Maintenance Study Including Re-induction Therapy for Patients Who Did Not Show a Clinical Effect in Study C87037 (NCT00291668)

Study Overview
=================
Brief Summary
-----------------
This 26-week extension study evaluates the efficacy and safety of certolizumab pegol administered subcutaneously every 4 weeks (dosed at Weeks 16, 20, 24, 28 and 32) in subjects with active Crohn's disease who had no clinical response at Week 6 to induction therapy in the 6-week double-blind main study, C87037 (NCT00291668), but subsequently showed clinical response at Week 14 to repeated induction therapy (dosed at Weeks 8, 10 and 12) in this extension study.

Detailed Description
-----------------
This study is an open-label extension study which follows on from the 6-week double-blind main study C87037 (NCT00291668). All 'Week' numbers quoted are relative to the start of the double-blind main study. The first visit in this extension study is at Week 8, and the final efficacy assessment in this extension study, 26 weeks later, is at Week 34.

Official Title
-----------------
A Multi-center, Open-label Study to Investigate the Efficacy and Safety of CDP870 in Active Crohn's Disease Patients, Who Showed no Clinical Efficacy in a Remission Induction Study (Study C87037) But Showed Clinical Efficacy After Additional Remission Induction Therapy Was Applied, at Week 26 After Subcutaneous Administration of CDP870 400 mg From Week 8 Until Week 24 at 4-week Intervals

Conditions
-----------------
Crohn's Disease

Intervention / Treatment
-----------------
* Biological: Certolizumab pegol
* Biological: Certolizumab pegol
* Biological: Certolizumab pegol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who gave written informed consent and who did not show clinical efficacy at Week 6 of the double-blind main study (NCT00291668) [reduction in Crohn's Disease Activity Index (CDAI) score of ≥100 points from Week 0, or remission (CDAI ≤150)] Exclusion Criteria: Subjects who experienced aggravation of Crohn's Disease during the double-blind main study (NCT00291668) and required treatment change

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 64 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CZP 400 mg / Placebo<br>Certolizumab pegol (CZP) 400 mg in this extension study / Placebo in double-blind main study (NCT00291668) | Biological: Certolizumab pegol<br>* Certolizumab pegol (CZP) 400 mg administered subcutaneously in a liquid formulation at Weeks 8, 10, 12, 16, 20, 24, 28 and 32 relative to the start of the 6-week double-blind main study C87037 (NCT00291668) where subjects received Placebo at Weeks 0, 2 and 4.<br>* Other names: CZP;|
| Experimental: CZP 400 mg / CZP 200 mg<br>Certolizumab pegol (CZP) 400 mg in this extension study / Certolizumab pegol (CZP) 200 mg in double-blind main study (NCT00291668) | Biological: Certolizumab pegol<br>* Certolizumab pegol (CZP) 400 mg administered subcutaneously in a liquid formulation at Weeks 8, 10, 12, 16, 20, 24, 28 and 32 relative to the start of the 6-week double-blind main study C87037 (NCT00291668) where subjects received Certolizumab pegol (CZP) 200 mg at Weeks 0, 2 and 4.<br>* Other names: CZP;|
| Experimental: CZP 400 mg / CZP 400 mg<br>Certolizumab pegol (CZP) 400 mg in this extension study / Certolizumab pegol (CZP) 400 mg in double-blind main study (NCT00291668) | Biological: Certolizumab pegol<br>* Certolizumab pegol (CZP) 400 mg administered subcutaneously in a liquid formulation at Weeks 8, 10, 12, 16, 20, 24, 28 and 32 relative to the start of the 6-week double-blind main study C87037 (NCT00291668) where subjects received Certolizumab pegol (CZP) 400 mg at Weeks 0, 2 and 4.<br>* Other names: CZP;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 34 | Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. | Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 8 | Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity. | Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study. | 
| Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 10 | Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity. | Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study. | 
| Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 12 | Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity. | Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study. | 
| Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 14 | Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity. | Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study. | 
| Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 16 | Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity. | Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study. | 
| Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 20 | Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity. | Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study. | 
| Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 24 | Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity. | Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study. | 
| Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 28 | Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity. | Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study. | 
| Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 32 | Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity. | Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study. | 
| Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 34 | Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity. | Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study. | 
| Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals) | Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity. | Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study. | 
| Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 8 | Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. | Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study. | 
| Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 10 | Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. | Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study. | 
| Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 12 | Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. | Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study. | 
| Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 14 | Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. | Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study. | 
| Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 16 | Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. | Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study. | 
| Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 20 | Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. | Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study. | 
| Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 24 | Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. | Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study. | 
| Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 28 | Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. | Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study. | 
| Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 32 | Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. | Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study. | 
| Percentage of Crohn's Disease Activity Index (CDAI) Responders at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals) | Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. | Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study. | 
| Percentage of Subjects Achieving Remission at Week 8 | Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. | Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study. | 
| Percentage of Subjects Achieving Remission at Week 10 | Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. | Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study. | 
| Percentage of Subjects Achieving Remission at Week 12 | Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. | Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study. | 
| Percentage of Subjects Achieving Remission at Week 14 | Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. | Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study. | 
| Percentage of Subjects Achieving Remission at Week 16 | Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. | Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study. | 
| Percentage of Subjects Achieving Remission at Week 20 | Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. | Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study. | 
| Percentage of Subjects Achieving Remission at Week 24 | Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. | Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study. | 
| Percentage of Subjects Achieving Remission at Week 28 | Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. | Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study. | 
| Percentage of Subjects Achieving Remission at Week 32 | Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. | Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study. | 
| Percentage of Subjects Achieving Remission at Week 34 | Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. | Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study. | 
| Percentage of Subjects Achieving Remission at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals) | Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. | Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study. | 
| Time to Disease Progression | Time to disease progression is defined as the earliest of: time to an increase from Week 14 of ≥100 points in Crohn's Disease Activity Index (CDAI) score and CDAI>175 points for at least 2 consecutive visits, time to use of rescue therapy, or, time to subject withdrawal from the study. | Week 14 to Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is the visit at which response to re-induction is assessed and 'Week 34' is 26 weeks after the first visit in this extension study. | 
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 8 | The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life. | Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study. | 
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 10 | The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life. | Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study. | 
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 12 | The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life. | Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study. | 
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 14 | The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life. | Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study. | 
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 16 | The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life. | Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study. | 
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 20 | The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life. | Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study. | 
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 24 | The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life. | Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study. | 
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 28 | The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life. | Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study. | 
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 32 | The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life. | Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study. | 
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 34 | The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life. | Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study. | 
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals) | The Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life. | Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study. | 
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 8 | The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study. | 
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 10 | The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study. | 
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 12 | The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study. | 
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 14 | The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study. | 
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 16 | The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study. | 
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 20 | The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study. | 
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 24 | The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study. | 
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 28 | The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study. | 
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 32 | The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study. | 
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 34 | The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study. | 
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals) | The Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study. | 
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 8 | The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study. | 
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 10 | The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study. | 
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 12 | The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study. | 
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 14 | The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study. | 
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 16 | The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study. | 
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 20 | The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study. | 
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 24 | The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study. | 
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 28 | The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study. | 
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 32 | The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study. | 
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 34 | The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study. | 
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals) | The Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study. | 
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 8 | The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study. | 
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 10 | The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study. | 
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 12 | The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study. | 
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 14 | The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study. | 
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 16 | The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study. | 
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 20 | The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study. | 
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 24 | The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study. | 
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 28 | The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study. | 
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 32 | The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study. | 
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 34 | The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study. | 
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals) | The Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study. | 
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 8 | The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study. | 
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 10 | The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study. | 
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 12 | The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study. | 
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 14 | The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study. | 
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 16 | The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study. | 
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 20 | The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study. | 
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 24 | The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study. | 
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 28 | The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study. | 
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 32 | The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study. | 
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 34 | The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study. | 
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals) | The Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study. | 
| C-Reactive Protein (CRP) Level at Week 0 |  | Week 0 (relative to the start of the 6-week double-blind main study (N00291668)). 'Week 0' is the Baseline visit in the double-blind main study. | 
| C-Reactive Protein (CRP) Level at Week 8 |  | Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study. | 
| C-Reactive Protein (CRP) Level at Week 10 |  | Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study. | 
| C-Reactive Protein (CRP) Level at Week 12 |  | Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study. | 
| C-Reactive Protein (CRP) Level at Week 14 |  | Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study. | 
| C-Reactive Protein (CRP) Level at Week 16 |  | Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study. | 
| C-Reactive Protein (CRP) Level at Week 20 |  | Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study. | 
| C-Reactive Protein (CRP) Level at Week 24 |  | Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study. | 
| C-Reactive Protein (CRP) Level at Week 28 |  | Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study. | 
| C-Reactive Protein (CRP) Level at Week 32 |  | Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study. | 
| C-Reactive Protein (CRP) Level at Week 34 |  | Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study. | 
| C-Reactive Protein (CRP) Level at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals) |  | Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study. | 
| Ratio of C-Reactive Protein (CRP) Level at Week 8 to CRP Level at Week 0 | The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 8 divided by the CRP Level at Week 0 | Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study. | 
| Ratio of C-Reactive Protein (CRP) Level at Week 10 to CRP Level at Week 0 | The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 10 divided by the CRP Level at Week 0 | Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study. | 
| Ratio of C-Reactive Protein (CRP) Level at Week 12 to CRP Level at Week 0 | The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 12 divided by the CRP Level at Week 0 | Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study. | 
| Ratio of C-Reactive Protein (CRP) Level at Week 14 to CRP Level at Week 0 | The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 14 divided by the CRP Level at Week 0 | Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study. | 
| Ratio of C-Reactive Protein (CRP) Level at Week 16 to CRP Level at Week 0 | The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 16 divided by the CRP Level at Week 0 | Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study. | 
| Ratio of C-Reactive Protein (CRP) Level at Week 20 to CRP Level at Week 0 | The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 20 divided by the CRP Level at Week 0 | Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study. | 
| Ratio of C-Reactive Protein (CRP) Level at Week 24 to CRP Level at Week 0 | The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 24 divided by the CRP Level at Week 0 | Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study. | 
| Ratio of C-Reactive Protein (CRP) Level at Week 28 to CRP Level at Week 0 | The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 28 divided by the CRP Level at Week 0 | Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study. | 
| Ratio of C-Reactive Protein (CRP) Level at Week 32 to CRP Level at Week 0 | The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 32 divided by the CRP Level at Week 0 | Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study. | 
| Ratio of C-Reactive Protein (CRP) Level at Week 34 to CRP Level at Week 0 | The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 34 divided by the CRP Level at Week 0 | Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study. | 
| Ratio of C-Reactive Protein (CRP) Level at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals) to CRP Level at Week 0 | The ratio is calculated as the C-Reactive Protein (CRP) Level at Last Visit (Week 34 for completers or the Withdrawal Visit for premature withdrawals)divided by the CRP Level at Week 0 | Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study. | 
| Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 8 | 70-point responders are subjects achieving a reduction in Crohn's Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. | Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study. | 
| Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 10 | 70-point responders are subjects achieving a reduction in Crohn's Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. | Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study. | 
| Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 12 | 70-point responders are subjects achieving a reduction in Crohn's Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. | Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study. | 
| Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 14 | 70-point responders are subjects achieving a reduction in Crohn's Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. | Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study. | 
| Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 16 | 70-point responders are subjects achieving a reduction in Crohn's Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. | Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study. | 
| Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 20 | 70-point responders are subjects achieving a reduction in Crohn's Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. | Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study. | 
| Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 24 | 70-point responders are subjects achieving a reduction in Crohn's Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. | Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study. | 
| Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 28 | 70-point responders are subjects achieving a reduction in Crohn's Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. | Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study. | 
| Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 32 | 70-point responders are subjects achieving a reduction in Crohn's Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. | Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study. | 
| Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 34 | 70-point responders are subjects achieving a reduction in Crohn's Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. | Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study. | 
| Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals) | 70-point responders are subjects achieving a reduction in Crohn's Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. | Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Crohn's Disease, CDP870, Certolizumab pegol, CZP