Examining the Long Term Safety, Efficacy, and Corticosteroid-sparing Effect of Certolizumab Pegol in Crohn's Disease (COSPAR II)
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|ClinicalTrials.gov Identifier: NCT00356408|
Recruitment Status : Completed
First Posted : July 26, 2006
Results First Posted : May 25, 2011
Last Update Posted : August 9, 2018
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|Condition or disease||Intervention/treatment||Phase|
|Crohn's Disease||Biological: Certolizumab pegol||Phase 3|
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||106 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Multi-center Trial to Examine the Long Term Safety, Efficacy, and Corticosteroid-sparing Effect of Certolizumab Pegol in Patients With Moderate to Severe Crohn's Disease Previously Enrolled in C87059 (COSPAR I, NCT00349752).|
|Study Start Date :||January 2007|
|Actual Primary Completion Date :||February 2010|
|Actual Study Completion Date :||February 2010|
Experimental: CDP870 400 mg
Certolizumab pegol (CDP870) 400 mg (2 injections of 1 mL) every 4 weeks from Week 2 until Week 34, or until CDP870 is available for a Crohn's disease indication in the patient's country. Subjects who were Non-completers of C87059 (COSPAR I, NCT00349752) receive an additional CDP870 400 mg dose at Week 2
Biological: Certolizumab pegol
Certolizumab pegol (CDP870), an anti-tumor necrosis factor (TNF)α, humanized antibody Fab' fragment - polyethylene glycol conjugate, solution for injection, in 10 mM sodium acetate buffer and 125 mM sodium chloride, pH 4.7, supplied in 3 mL vials with a fill of 1.4 mL (an extractable volume of 1 mL corresponds to a dose of 200 mg).
Dosing is every 4 weeks from Week 2 until Week 34, or until CDP870 is available for a Crohn's disease indication in the patient's country. Subjects who were Non-completers of C87059 (COSPAR I, NCT00349752) receive an additional CDP870 400 mg dose at Week 2.
- Occurrence of at Least One Treatment-emergent Adverse Event During This Study (Maximum 122 Weeks) [ Time Frame: During this study (maximum 122 weeks) ]Results are presented as the number of subjects with at least one treatment-emergent adverse event during this study.
- Disease Remission (Crohn's Disease Activity Index, CDAI≤150) at Week 34 in Patients Who Completed/Did Not Complete C87059 (COSPAR I, NCT00349752) and Remained Off Corticosteroids. [ Time Frame: Week 34 in this study ]Crohn's disease activity index (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 disease remission at Week 34.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Patients previously enrolled in C87059 (COSPAR I, NCT00349752)
- Subject withdrawn or discontinued from C87059 (COSPAR I, NCT00349752) study under specific conditions
- Subject who received treatment other than study medication and other than medications permitted in C87059 (COSPAR I, NCT00349752)
- Subjects from countries where certolizumab pegol is authorized in Crohn's disease treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00356408
|Study Director:||UCB Clinical Trial Call Center||+1 877 822 9493 (UCB)|
|Responsible Party:||UCB Pharma|
|Other Study ID Numbers:||
2006-003871-11 ( EudraCT Number )
|First Posted:||July 26, 2006 Key Record Dates|
|Results First Posted:||May 25, 2011|
|Last Update Posted:||August 9, 2018|
|Last Verified:||April 2011|
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