Phase 3
Completed N=103
Examining the Long Term Safety, Efficacy, and Corticosteroid-sparing Effect of Certolizumab Pegol in Crohn's Disease
Source: ClinicalTrials.gov NCT00356408 ↗Enrolled (actual)
103
Serious AEs
14.6%
Results posted
May 2011
Primary outcomePrimary: Occurrence of at Least One Treatment-emergent Adverse Event During This Study (Maximum 122 Weeks) — 12; 15; 32; 30 subjects
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Occurrence of at Least One Treatment-emergent Adverse Event During This Study (Maximum 122 Weeks) |
12; 15; 32; 30 | — |
| SECONDARY 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. |
28.6; 37.5; 35.0; 3.0 | — |
Eligibility Criteria
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- Subject withdrawn or discontinued from C87059 (COSPAR I, NCT00349752) study under specific conditions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
Data sourced from ClinicalTrials.gov (NCT00356408). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.