Examining the Long Term Safety, Efficacy, and Corticosteroid-sparing Effect of Certolizumab Pegol in Crohn's Disease

Study Overview
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Brief Summary
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This is an open-label extension study designed to measure the safety, efficacy, and corticosteroid-sparing effect of certolizumab pegol (CDP870) in patients with moderate to severe Crohn's disease previously enrolled in C87059 (COSPAR I, NCT00349752).

Official Title
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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).

Conditions
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Crohn's Disease

Intervention / Treatment
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* Biological: Certolizumab pegol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients previously enrolled in C87059 (COSPAR I, NCT00349752) Exclusion Criteria: Subject withdrawn or discontinued from C87059 (COSPAR I, NCT00349752) study under specific conditions Subject who received treatment other than study medication and other than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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CDP870 400 mg<br>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<br>* 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.<br>* Other names: Cimzia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of at Least One Treatment-emergent Adverse Event 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. | During this study (maximum 122 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Week 34 in this study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CDP870, certolizumab pegol, Crohn's Disease