Phase 3
Completed N=439
Study to Evaluate Efficacy and Safety of Certolizumab Pegol for Induction of Remission in Patients With Crohn's Disease
Crohn Disease
Source: ClinicalTrials.gov NCT00552058 ↗
Enrolled (actual)
439
Serious AEs
4.6%
Results posted
Dec 2010
Primary outcomePrimary: Percentage of Subjects in Clinical Remission at Week 6 — 31.6; 25.4 percentage of subjects
Summary
The primary objective of the study is to evaluate efficacy of certolizumab pegol in inducing clinical remission in patients with moderate to severe Crohn's disease as compared with placebo based on Crohn's Disease Activity Index (CDAI) score at Week 6.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects in Clinical Remission at Week 6 |
31.6; 25.4 | — |
| SECONDARY Percentage of Subjects Achieving a Clinical Response at Week 6 |
40.5; 34.0 | — |
| SECONDARY Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 6 |
36.7; 28.7 | — |
| SECONDARY Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 6 |
-96.7; -73.1 | — |
| SECONDARY Change in Harvey Bradshaw Index (HBI) Score From Week 0 to Week 6 |
-3.3; -2.6 | — |
| SECONDARY Percentage of Subjects in Clinical Remission at Week 2 |
23.3; 15.8 | — |
| SECONDARY Percentage of Subjects in Clinical Remission at Week 4 |
26.5; 19.1 | — |
| SECONDARY Percentage of Subjects Achieving a Clinical Response at Week 2 |
33.0; 20.1 | — |
| SECONDARY Percentage of Subjects Achieving a Clinical Response at Week 4 |
35.3; 26.3 | — |
| SECONDARY Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 2 |
-72.6; -41.8 | — |
| SECONDARY Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 4 |
-88.8; -65.7 | — |
| SECONDARY Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 2 |
25.6; 18.2 | — |
| SECONDARY Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 4 |
33.5; 23.9 | — |
| SECONDARY Percentage of Subjects in Subgroup With Less Than 10 mg/L C-reactive Protein (CRP) at Entry Who Are in Clinical Remission at Week 6 |
30.3; 30.1 | — |
| SECONDARY Percentage of Subjects in Subgroup With 10 mg/L or Greater C-reactive Protein (CRP) at Entry Who Are in Clinical Remission at Week 6 |
33.3; 19.8 | — |
| SECONDARY Percentage of Subjects in Subgroup With Less Than 10 mg/L C-reactive Protein (CRP) at Entry Achieving a Clinical Response at Week 6 |
37.7; 35.4 | — |
| SECONDARY Percentage of Subjects in Subgroup With 10 mg/L or Greater C-reactive Protein (CRP) at Entry Achieving a Clinical Response at Week 6 |
44.1; 32.3 | — |
Eligibility Criteria
Inclusion Criteria
- male/female
- 18 - 75 years inclusive
- diagnosis of Crohn's disease confirmed
- moderate to severe disease activity (Crohn's Disease Activity Index (CDAI) 225 - 450)
- no previous treatment with anti-tumor necrosis factor (anti-TNF) medications
Exclusion Criteria
- previous participation in a certolizumab pegol study
- general exclusion criteria as common for studies in this indication
Data sourced from ClinicalTrials.gov (NCT00552058). 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.