Maintenance Study Including Re-induction Therapy for Patients Who Did Not Show a Clinical Effect in Study C87037 (NCT00291668)
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
2 other identifiers
interventional
46
1 country
23
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2006
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 22, 2006
CompletedFirst Posted
Study publicly available on registry
May 24, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedResults Posted
Study results publicly available
November 10, 2009
CompletedMarch 18, 2015
February 1, 2015
2 years
May 22, 2006
May 1, 2009
February 27, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (122)
Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 8
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
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
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
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
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.
- +117 more secondary outcomes
Study Arms (3)
CZP 400 mg / Placebo
EXPERIMENTALCertolizumab pegol (CZP) 400 mg in this extension study / Placebo in double-blind main study (NCT00291668)
CZP 400 mg / CZP 200 mg
EXPERIMENTALCertolizumab pegol (CZP) 400 mg in this extension study / Certolizumab pegol (CZP) 200 mg in double-blind main study (NCT00291668)
CZP 400 mg / CZP 400 mg
EXPERIMENTALCertolizumab pegol (CZP) 400 mg in this extension study / Certolizumab pegol (CZP) 400 mg in double-blind main study (NCT00291668)
Interventions
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.
Eligibility Criteria
You may qualify if:
- Subjects who gave written informed consent and who did not show clinical efficacy at Week 6 of the double-blind main study (NCT00291668) \[reduction in Crohn's Disease Activity Index (CDAI) score of ≥100 points from Week 0, or remission (CDAI ≤150)\]
You may not qualify if:
- Subjects who experienced aggravation of Crohn's Disease during the double-blind main study (NCT00291668) and required treatment change
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (23)
Unknown Facility
Aichi-Gun, Aichi-ken, Japan
Unknown Facility
Nagoya, Aichi-ken, Japan
Unknown Facility
Toyoake, Aichi-ken, Japan
Unknown Facility
Toyohashi, Aichi-ken, Japan
Unknown Facility
Kashiwa, Chiba, Japan
Unknown Facility
Sakura, Chiba, Japan
Unknown Facility
Chikusino, Fukuoka, Japan
Unknown Facility
Fukuoka, Fukuoka, Japan
Unknown Facility
Asahikawa, Hokkaido, Japan
Unknown Facility
Sapporo, Hokkaido, Japan
Unknown Facility
Nishinomiya, Hyōgo, Japan
Unknown Facility
Kagoshima, Kagoshima-ken, Japan
Unknown Facility
Yokohama, Kanagawa, Japan
Unknown Facility
Miyazaki-gun, Miyazaki, Japan
Unknown Facility
Nagasaki, Nagasaki, Japan
Unknown Facility
Niigata, Niigata, Japan
Unknown Facility
Kurashiki, Okayama-ken, Japan
Unknown Facility
Tyuto-gun, Okianawa, Japan
Unknown Facility
Osaka, Osaka, Japan
Unknown Facility
Osaka Suita, Osaka, Japan
Unknown Facility
Shiga Otsu, Shiga, Japan
Unknown Facility
Shinjyuku/Tokyo, Tokyo, Japan
Unknown Facility
Shinjyuku, Tokyo, Japan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Due to the small number of subjects in this study, the percentages of subjects with adverse events may be misleading.
Results Point of Contact
- Title
- UCB Clinical Trial Call Center
- Organization
- UCB Pharma
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
+1 877 822 9493 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2006
First Posted
May 24, 2006
Study Start
May 1, 2006
Primary Completion
May 1, 2008
Study Completion
May 1, 2008
Last Updated
March 18, 2015
Results First Posted
November 10, 2009
Record last verified: 2015-02