Clinical trial NCT00329420: Maintenance Study Including Re-induction Therapy for Patients Who Did Not Show a Clinical Effect in Study C87037 (NCT00291668)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Crohn's Disease
Keywords: Crohn's Disease
CDP870
Certolizumab pegol
CZP
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2006-05-24
Enrollment: 46
Sex: ALL
Minimum age (years): 16
Maximum age (years): 64
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 34
timeFrame: 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 outcomes:
measure: Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 8
timeFrame: 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.
measure: Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 10
timeFrame: 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.
measure: Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 12
timeFrame: 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.
measure: Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 14
timeFrame: 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.
measure: Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 16
timeFrame: 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.
measure: Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 20
timeFrame: 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.
measure: Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 24
timeFrame: 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.
measure: Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 28
timeFrame: 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.
measure: Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 32
timeFrame: 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.
measure: Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 34
timeFrame: 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.
measure: 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)
timeFrame: 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.
measure: Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 8
timeFrame: 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.
measure: Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 10
timeFrame: 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.
measure: Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 12
timeFrame: 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.
measure: Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 14
timeFrame: 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.
measure: Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 16
timeFrame: 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.
measure: Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 20
timeFrame: 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.
measure: Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 24
timeFrame: 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.
measure: Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 28
timeFrame: 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.
measure: Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 32
timeFrame: 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.
measure: Percentage of Crohn's Disease Activity Index (CDAI) Responders at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)
timeFrame: 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.
measure: Percentage of Subjects Achieving Remission at Week 8
timeFrame: 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.
measure: Percentage of Subjects Achieving Remission at Week 10
timeFrame: 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.
measure: Percentage of Subjects Achieving Remission at Week 12
timeFrame: 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.
measure: Percentage of Subjects Achieving Remission at Week 14
timeFrame: 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.
measure: Percentage of Subjects Achieving Remission at Week 16
timeFrame: 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.
measure: Percentage of Subjects Achieving Remission at Week 20
timeFrame: 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.
measure: Percentage of Subjects Achieving Remission at Week 24
timeFrame: 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.
measure: Percentage of Subjects Achieving Remission at Week 28
timeFrame: 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.
measure: Percentage of Subjects Achieving Remission at Week 32
timeFrame: 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.
measure: Percentage of Subjects Achieving Remission at Week 34
timeFrame: 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.
measure: Percentage of Subjects Achieving Remission at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)
timeFrame: 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.
measure: Time to Disease Progression
timeFrame: 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.
measure: Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 8
timeFrame: 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.
measure: Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 10
timeFrame: 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.
measure: Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 12
timeFrame: 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.
measure: Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 14
timeFrame: 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.
measure: Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 16
timeFrame: 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.
measure: Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 20
timeFrame: 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.
measure: Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 24
timeFrame: 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.
measure: Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 28
timeFrame: 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.
measure: Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 32
timeFrame: 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.
measure: Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 34
timeFrame: 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.
measure: 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)
timeFrame: 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.
measure: Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 8
timeFrame: 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.
measure: Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 10
timeFrame: 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.
measure: Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 12
timeFrame: 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.
measure: Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 14
timeFrame: 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.
measure: Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 16
timeFrame: 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.
measure: Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 20
timeFrame: 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.
measure: Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 24
timeFrame: 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.
measure: Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 28
timeFrame: 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.
measure: Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 32
timeFrame: 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.
measure: Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 34
timeFrame: 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.
measure: 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)
timeFrame: 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.
measure: Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 8
timeFrame: 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.
measure: Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 10
timeFrame: 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.
measure: Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 12
timeFrame: 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.
measure: Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 14
timeFrame: 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.
measure: Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 16
timeFrame: 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.
measure: Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 20
timeFrame: 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.
measure: Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 24
timeFrame: 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.
measure: Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 28
timeFrame: 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.
measure: Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 32
timeFrame: 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.
measure: Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 34
timeFrame: 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.
measure: 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)
timeFrame: 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.
measure: Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 8
timeFrame: 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.
measure: Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 10
timeFrame: 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.
measure: Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 12
timeFrame: 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.
measure: Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 14
timeFrame: 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.
measure: Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 16
timeFrame: 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.
measure: Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 20
timeFrame: 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.
measure: Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 24
timeFrame: 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.
measure: Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 28
timeFrame: 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.
measure: Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 32
timeFrame: 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.
measure: Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 34
timeFrame: 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.
measure: 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)
timeFrame: 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.
measure: Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 8
timeFrame: 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.
measure: Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 10
timeFrame: 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.
measure: Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 12
timeFrame: 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.
measure: Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 14
timeFrame: 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.
measure: Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 16
timeFrame: 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.
measure: Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 20
timeFrame: 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.
measure: Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 24
timeFrame: 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.
measure: Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 28
timeFrame: 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.
measure: Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 32
timeFrame: 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.
measure: Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 34
timeFrame: 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.
measure: 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)
timeFrame: 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.
measure: C-Reactive Protein (CRP) Level at Week 0
timeFrame: 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.
measure: C-Reactive Protein (CRP) Level at Week 8
timeFrame: 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.
measure: C-Reactive Protein (CRP) Level at Week 10
timeFrame: 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.
measure: C-Reactive Protein (CRP) Level at Week 12
timeFrame: 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.
measure: C-Reactive Protein (CRP) Level at Week 14
timeFrame: 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.
measure: C-Reactive Protein (CRP) Level at Week 16
timeFrame: 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.
measure: C-Reactive Protein (CRP) Level at Week 20
timeFrame: 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.
measure: C-Reactive Protein (CRP) Level at Week 24
timeFrame: 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.
measure: C-Reactive Protein (CRP) Level at Week 28
timeFrame: 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.
measure: C-Reactive Protein (CRP) Level at Week 32
timeFrame: 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.
measure: C-Reactive Protein (CRP) Level at Week 34
timeFrame: 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.
measure: C-Reactive Protein (CRP) Level at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)
timeFrame: 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.
measure: Ratio of C-Reactive Protein (CRP) Level at Week 8 to CRP Level at Week 0
timeFrame: 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.
measure: Ratio of C-Reactive Protein (CRP) Level at Week 10 to CRP Level at Week 0
timeFrame: 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.
measure: Ratio of C-Reactive Protein (CRP) Level at Week 12 to CRP Level at Week 0
timeFrame: 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.
measure: Ratio of C-Reactive Protein (CRP) Level at Week 14 to CRP Level at Week 0
timeFrame: 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.
measure: Ratio of C-Reactive Protein (CRP) Level at Week 16 to CRP Level at Week 0
timeFrame: 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.
measure: Ratio of C-Reactive Protein (CRP) Level at Week 20 to CRP Level at Week 0
timeFrame: 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.
measure: Ratio of C-Reactive Protein (CRP) Level at Week 24 to CRP Level at Week 0
timeFrame: 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.
measure: Ratio of C-Reactive Protein (CRP) Level at Week 28 to CRP Level at Week 0
timeFrame: 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.
measure: Ratio of C-Reactive Protein (CRP) Level at Week 32 to CRP Level at Week 0
timeFrame: 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.
measure: Ratio of C-Reactive Protein (CRP) Level at Week 34 to CRP Level at Week 0
timeFrame: 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.
measure: 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
timeFrame: 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.
measure: Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 8
timeFrame: 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.
measure: Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 10
timeFrame: 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.
measure: Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 12
timeFrame: 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.
measure: Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 14
timeFrame: 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.
measure: Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 16
timeFrame: 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.
measure: Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 20
timeFrame: 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.
measure: Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 24
timeFrame: 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.
measure: Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 28
timeFrame: 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.
measure: Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 32
timeFrame: 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.
measure: Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 34
timeFrame: 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.
measure: 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)
timeFrame: 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.
Other outcomes:
Locations:
city: Aichi-Gun
country: Japan
state: Aichi
city: Nagoya
country: Japan
state: Aichi
city: Toyoake
country: Japan
state: Aichi
city: Toyohashi
country: Japan
state: Aichi
city: Kashiwa
country: Japan
state: Chiba
city: Sakura
country: Japan
state: Chiba
city: Chikusino
country: Japan
state: Fukuoka
city: Asahikawa
country: Japan
state: Hokkaido
city: Sapporo
country: Japan
state: Hokkaido
city: Nishinomiya
country: Japan
state: Hyogo
city: Yokohama
country: Japan
state: Kanagawa
city: Miyazaki-gun
country: Japan
state: Miyazaki
city: Kurashiki
country: Japan
state: Okayama
city: Tyuto-gun
country: Japan
state: Okianawa
city: Osaka Suita
country: Japan
state: Osaka
city: Shiga Otsu
country: Japan
state: Shiga
city: Shinjyuku/Tokyo
country: Japan
state: Tokyo
city: Shinjyuku
country: Japan
state: Tokyo
city: Fukuoka
country: Japan
city: Kagoshima
country: Japan
city: Nagasaki
country: Japan
city: Niigata
country: Japan
city: Osaka
country: Japan
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: