Follow-up to Welcome Study C87042 [NCT00308581] Examining Certolizumab Pegol (CDP870) in Subjects With Crohn's Disease

Study Overview
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Brief Summary
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The study will continue to assess the safety of certolizumab pegol (CDP870) as well as examine the evolution of long term efficacy in Crohn's disease patients who completed study C87042 [NCT00308581]. It will also assess the effect of subcutaneous CDP870 400 mg on direct cost parameters.

Official Title
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Open Label Long Term Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy With Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor Alpha (TNF) in Patients Suffering From Crohn's Disease and Having Completed C87042 Study.

Conditions
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Crohn's Disease

Intervention / Treatment
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* Biological: Certolizumab pegol (CDP870)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients having completed study C87042 [NCT00308581] (previously treated with infliximab) Exclusion Criteria: Subject withdraw from C87042 [NCT00308581] study Subject who received treatment other than certolizumab pegol and other than medications permitted in C87042 [NCT00308581] study Subjects from countries where certolizumab pegol is authorized in Crohn's disease treatment Female patients of childbearing age who are NOT practicing (in the Investigator's opinion) effective birth control. All female patients must test negative on a serum pregnancy test before study entry and negative on urine testing immediately before every certolizumab pegol administration

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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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: Certolizumab pegol 400 mg<br>400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks | Biological: Certolizumab pegol (CDP870)<br>* 400 mg subcutaneous (sc) injection of Certolizumab pegol (CDP870) every 2 (Q2W) or 4 (Q4W) weeks<br>* Other names: Cimzia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of at Least One Study-emergent Adverse Event During the Study (Maximum 164 Weeks) | Study-emergent adverse events are defined as treatment-emergent adverse events with an onset date on or after the first study drug administration date of this study but not later than 12 weeks (84 days) after last injection. Results are presented as the percentage of subjects with at least one treatment-emergent adverse event during this study. | Maximum 164 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maintenance of Response at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals] Among the Subjects in Clinical Response at Baseline of This Study (Week 26 of Study C87042). | Clinical response is defined as at least a 100 point decrease from Baseline of study C87042 (NCT00308581) in Crohn's Disease Activity Index (CDAI). Subjects maintained their clinical response at Last Visit if they did not meet criteria for loss of response [CDAI score >150 points and a minimum increase in CDAI of 70 points versus Baseline of study C87042 (NCT00308581)] at 2 consecutive visits. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. Results are presented as the percentage of subjects maintaining response at Last visit. | Baseline (corresponding to Week 26 of study C87042 (NCT00308581) and Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals] | 
| Clinical Response at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals] | Clinical response is defined as at least a 100 point decrease from Baseline of study C87042 (NCT00308581) in Crohn's Disease Activity Index (CDAI). CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. Results are presented as the percentage of subjects achieving clinical response at Last visit. | Baseline of study C87042 (NCT00308581) and Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals] | 
| Remission at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals] | Remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. Results are presented as the percentage of subjects in remission at Last visit. | Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals] | 
| Change From Baseline of Study C87042 (NCT00308581) in Crohn's Disease Activity Index (CDAI) at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals] | CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. | Baseline of study C87042 (NCT00308581) and Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals] | 
| Time to Loss of Response After Baseline of Study C87042 (NCT00308581) on Subjects Who Were in Clinical Response at Baseline of This Study | Clinical response at Baseline of this study of at least a 100 point decrease from Baseline of study C87042 in Crohn's Disease Activity Index (CDAI) Loss of response = both a CDAI score >150 points and a minimum increase in CDAI of 70 points versus Baseline (Week 26 of study C87042) as confirmed at 2 consecutive visits. Subjects losing response will be considered as having the event on the date of the first visit where response was lost. Subjects who discontinued the study without having lost response will be censored on the date of discontinuation (i.e. date of last visit performed). | Maximum 154 weeks | 
| Occurrence of at Least 1 Hospital Stay During the Treatment Period | The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit. Results are presented as the percentage of subjects with at least 1 hospital stay during the treatment period. | Maximum 152 weeks | 
| Occurrence of at Least 1 Hospital Stay During the Follow-Up Period | Follow-up period starts the day after the last injection up to 84 days after last injection. Results are presented as the percentage of subjects with at least 1 hospital stay during the follow-up period. | Maximum 12 weeks | 
| Occurrence of at Least 1 Hospital Stay During the During the Overall Period | Overall period corresponds to both treatment and follow-up periods in C87046. Results are presented as the percentage of subjects with at least 1 hospital stay during the overall period. | Maximum 164 weeks | 
| Length of Hospital Stays During the Treatment Period | The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit. | Maximum 152 weeks | 
| Length of Hospital Stays During the Follow-Up Period | Follow-up period starts the day after the last injection up to 84 days after last injection. | Maximum 12 weeks | 
| Length of Hospital Stays During the Overall Period | Overall period corresponds to both treatment and follow-up periods in C87046. | Maximum 164 weeks | 
| Occurrence of at Least 1 Emergency Room Visit During the Treatment Period | The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit. Results are presented as the percentage of subjects with at least 1 emergency room visit during the treatment period. | Maximum 152 weeks | 
| Occurrence of at Least 1 Emergency Room Visit During the Follow-Up Period | Follow-up period starts the day after the last injection up to 84 days after last injection. Results are presented as the percentage of subjects with at least 1 emergency room visit during the follow-up period. | Maximum 12 weeks | 
| Occurrence of at Least 1 Emergency Room Visit During the Overall Period | Overall period corresponds to both treatment and follow-up periods in C87046. Results are presented as the percentage of subjects with at least 1 emergency room visit during the overall period. | Maximum 164 weeks | 
| Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Treatment Period | The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit. Medication categories are anti tumor necrosis factor (anti-TNFs), immunosuppressants, corticosteroids, 5 aminosalicylic acid (5-ASA) and antibiotics. Results are presented as the percentage of subjects with at least 1 concomitant medication potentially influencing Crohn's disease during the treatment period. | Maximum 152 weeks | 
| Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Follow-Up Period | Follow-up period start the day after the last injection up to 84 days after last injection. Medication categories are anti tumor necrosis factor (anti-TNFs), immunosuppressants, corticosteroids, 5 aminosalicylic acid (5-ASA) and antibiotics. Results are presented as the percentage of subjects with at least 1 concomitant medication potentially influencing Crohn's disease during the follow-up period. | Maximum 12 weeks | 
| Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Overall Period | Overall period corresponds to both treatment and follow-up periods in C87046. Medication categories are anti tumor necrosis factor (anti-TNFs), immunosuppressants, corticosteroids, 5 aminosalicylic acid (5-ASA) and antibiotics. Results are presented as the percentage of subjects with at least 1 concomitant medication potentially influencing Crohn's disease during the overall period. | Maximum 164 weeks | 
| Occurrence of at Least 1 General Concomitant Medication During the Treatment Period | The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit. Results are presented as the number of subjects who used at least 1 concomitant medication during the treatment period. | Maximum 152 weeks | 
| Occurrence of at Least 1 General Concomitant Medication During the Follow-Up Period | Follow-up period start the day after the last injection up to 84 days after last injection. Results are presented as the number of subjects who used at least 1 concomitant medication during the follow-up period. | Maximum 12 weeks | 
| Occurrence of at Least 1 General Concomitant Medication During the Overall Period | Overall period corresponds to both treatment and follow-up periods in C87046. Results are presented as the number of subjects who used at least 1 concomitant medication during the overall period. | Maximum 164 weeks | 
| Occurrence of at Least 1 Concurrent Medical Procedure During the Treatment Period. | The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit. Results are presented as the number of subjects who had at least 1 concurrent medical procedure during the treatment period. | Maximum 152 weeks | 
| Occurrence of at Least 1 Concurrent Medical Procedure During the Follow-Up Period | Follow-up period start the day after the last injection up to 84 days after last injection. Results are presented as the number of subjects who had at least 1 concurrent medical procedure during the follow-up period. | Maximum 12 weeks | 
| Occurrence of at Least 1 Concurrent Medical Procedure During the Overall Period | Overall period corresponds to both treatment and follow-up periods in C87046. Results are presented as the number of subjects who had at least 1 concurrent medical procedure during the overall period. | Maximum 164 weeks | 

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