Follow-up to Welcome Study C87042 [NCT00308581] Examining Certolizumab Pegol (CDP870) in Subjects With Crohn's Disease
Welcome2
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.
2 other identifiers
interventional
233
12 countries
65
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2006
Typical duration for phase_3
65 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 2, 2006
CompletedFirst Posted
Study publicly available on registry
June 6, 2006
CompletedStudy Start
First participant enrolled
October 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedResults Posted
Study results publicly available
July 12, 2011
CompletedAugust 7, 2018
August 1, 2011
3.5 years
June 2, 2006
April 13, 2011
July 10, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (23)
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).
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]
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]
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]
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
Maximum 154 weeks
- +18 more secondary outcomes
Study Arms (1)
Certolizumab pegol 400 mg
EXPERIMENTAL400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Interventions
400 mg subcutaneous (sc) injection of Certolizumab pegol (CDP870) every 2 (Q2W) or 4 (Q4W) weeks
Eligibility Criteria
You may qualify if:
- Patients having completed study C87042 \[NCT00308581\] (previously treated with infliximab)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (65)
Unknown Facility
Gainesville, Florida, United States
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Atlanta, Georgia, United States
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Chicago, Illinois, United States
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Indianapolis, Indiana, United States
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Louisville, Kentucky, United States
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Baton Rouge, Louisiana, United States
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Lincoln, Nebraska, United States
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New York, New York, United States
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Chapel Hill, North Carolina, United States
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Charleston, North Carolina, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Portland, Oregon, United States
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Charleston, South Carolina, United States
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Germantown, Tennessee, United States
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Nashville, Tennessee, United States
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Houston, Texas, United States
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Seattle, Washington, United States
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Innsbruck, Austria
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Vienna, Austria
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Bonheiden, Belgium
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Brussels, Belgium
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Genk, Belgium
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Ghent, Belgium
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Leuven, Belgium
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Liège, Belgium
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Roeselare, Belgium
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Edmonton, Alberta, Canada
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Vancouver, British Columbia, Canada
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London, Ontario, Canada
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Toronto, Ontario, Canada
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Calgary, Canada
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Clichy, France
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Lille, France
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Nice, France
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Paris, France
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Pessac, France
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Berlin, Germany
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Hamburg, Germany
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Herne, Germany
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Kiel, Germany
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Leipzig, Germany
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Minden, Germany
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Munich, Germany
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München, Germany
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Bologna, Italy
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Milan, Italy
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Padua, Italy
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Palermo, Italy
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Roma, Italy
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Torino, Italy
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Eindhoven, Netherlands
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Heerlen, Netherlands
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Barcelona, Spain
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Madrid, Spain
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Santiago de Compostela, Spain
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Seville, Spain
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Valencia, Spain
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Stockholm, Sweden
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Bern, Switzerland
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Lausanne, Switzerland
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Bristol, United Kingdom
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London, United Kingdom
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Oxford, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB Clinical Trial Call Center
- Organization
- UCB, Inc
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 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
June 2, 2006
First Posted
June 6, 2006
Study Start
October 1, 2006
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
August 7, 2018
Results First Posted
July 12, 2011
Record last verified: 2011-08