Clinical trial NCT00329550: Maintenance Study of Certolizumab Pegol (CZP) in Crohn's Disease
Official title: A 26-week, Multi-center, Open-label Study to Investigate the Efficacy and Safety of CDP870 in Active Crohn's Disease Patients, Who Showed Clinical Efficacy in a Remission Induction Study (Study C87037 [NCT00291668]), 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: Certolizumab pegol
Cimzia
CZP
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2006-05-24
Enrollment: 40
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 is a multi-centre, open-label extension study in subjects who showed clinical response to induction therapy in the treatment of subjects with active Crohn's disease in the double-blind main study C87037 (NCT00291668).

Detailed description: In the double-blind main study subjects were dosed at Weeks 0, 2 and 4, with the primary outcome, clinical response, being assessed at Week 6. Subjects who showed clinical response at Week 6 were eligible to enter this open-label extension study. The first visit in this extension study was 2 weeks after Week 6, i.e., Week 8. Subjects in this extension study were dosed at Weeks 8, 12, 16, 20 and 24, with the primary outcome, clinical response, being assessed at Week 26. All week numbers quoted are relative to the start of the double-blind main study.

Eligibility criteria: Inclusion Criteria:

* Subjects who participated in main double-blind induction study C87037 (NCT00291668) and showed clinical efficacy

Exclusion Criteria:

* Subjects who experienced aggravation of Crohn's disease during main double-blind induction study C87037 (NCT00291668) and required treatment change

Primary outcomes:
measure: Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 26
timeFrame: Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 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 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 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 26
timeFrame: Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 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 26 for Completers or the Withdrawal Visit for Premature Withdrawals]
timeFrame: Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 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 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 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 Last Visit [Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals]
timeFrame: Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 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 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 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 26
timeFrame: Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.
measure: Percentage of Subjects Achieving Remission at Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals)
timeFrame: Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.
measure: Time to Disease Progression
timeFrame: Week 6 to Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 6' is the last visit in the double-blind main study and 'Week 26' is 18 weeks after the first visit in this extension study.
measure: Change From Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score
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 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score
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 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score
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 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score
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 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score
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 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score
timeFrame: Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.
measure: Change From Week 0 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score
timeFrame: Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.
measure: Change From Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score
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 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score
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 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score
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 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score
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 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score
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 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score
timeFrame: Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.
measure: Change From Week 0 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score
timeFrame: Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.
measure: Change From Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score
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 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score
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 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score
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 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score
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 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score
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 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score
timeFrame: Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.
measure: Change From Week 0 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score
timeFrame: Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.
measure: Change From Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score
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 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score
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 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score
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 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score
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 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score
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 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score
timeFrame: Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.
measure: Change From Week 0 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score
timeFrame: Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.
measure: Change From Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score
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 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score
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 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score
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 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score
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 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score
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 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score
timeFrame: Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.
measure: Change From Week 0 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score
timeFrame: Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 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 (NCT00291668)). '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 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 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 26
timeFrame: Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.
measure: C-Reactive Protein (CRP) Level at Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals)
timeFrame: Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.
measure: Ratio of C-Reactive Protein (CRP) Level at Week 8 to 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 12 to 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 16 to 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 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 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 26 to Week 0
timeFrame: Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.
measure: Ratio of C-Reactive Protein (CRP) Level at Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) to Week 0
timeFrame: Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.
measure: Percentage of Subjects at Week 8 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From 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: Percentage of Subjects at Week 12 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From 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: Percentage of Subjects at Week 16 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From 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: Percentage of Subjects at Week 20 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From 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: Percentage of Subjects at Week 24 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From 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: Percentage of Subjects at Week 26 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0
timeFrame: Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.
measure: Percentage of Subjects at Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0
timeFrame: Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 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: Okinawa
city: Suita
country: Japan
state: Osaka
city: 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: PRINCIPAL_INVESTIGATOR
References: