Phase 2
N=94
Clinical Study of CDP870/Certolizumab Pegol in Patients With Active Crohn's Disease
Crohn's Disease
Bottom Line
View on ClinicalTrials.gov: NCT00291668 ↗Enrolled (actual)
94
Serious AEs
7.4%
Results posted
Aug 2020
Primary outcome: Primary: Crohn's Disease Activity Index (CDAI) Response (Clinical Response or Remission) at Week 6 — 25.0; 43.3; 48.4 percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Certolizumab Pegol (Biological); Placebo (Other)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- UCB Pharma
- Primary completion
- Nov 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Crohn's Disease Activity Index (CDAI) Response (Clinical Response or Remission) at Week 6 |
25.0; 43.3; 48.4 | — |
| SECONDARY Crohn's Disease Activity Index (CDAI) Score at Week 2 |
255.9; 214.2; 224.9 | — |
| SECONDARY Crohn's Disease Activity Index (CDAI) Score at Week 4 |
243.1; 199.7; 204.6 | — |
| SECONDARY Crohn's Disease Activity Index (CDAI) Score at Week 6 |
232.4; 211.0; 198.1 | — |
| SECONDARY Percentage of Subjects Who Achieve CDAI Response at Week 2 |
15.6; 40.0; 32.3 | — |
| SECONDARY Percentage of Subjects Who Achieve CDAI Response at Week 4 |
21.9; 46.7; 38.7 | — |
| SECONDARY Percentage of Subjects Who Achieve a Reduction in CDAI Scores of at Least 70 Points at Week 2 |
28.1; 46.7; 45.2 | — |
| SECONDARY Percentage of Subjects Who Achieve a Reduction in CDAI Scores of at Least 70 Points at Week 4 |
25.0; 56.7; 54.8 | — |
| SECONDARY Percentage of Subjects Who Achieve a Reduction in CDAI Scores of at Least 70 Points at Week 6 |
43.8; 53.3; 61.3 | — |
| SECONDARY Percentage of Subjects Who Achieve Remission (CDAI <= 150) at Week 2 |
3.1; 20.0; 16.1 | — |
| SECONDARY Percentage of Subjects Who Achieve Remission (CDAI <= 150) at Week 4 |
6.3; 26.7; 22.6 | — |
| SECONDARY Percentage of Subjects Who Achieve Remission (CDAI <= 150) at Week 6 |
15.6; 26.7; 32.3 | — |
| SECONDARY Percentage of Subjects Who Achieve Clinical Response (Reduction in CDAI Scores of at Least 100 Points) at Week 2 |
15.6; 36.7; 29.0 | — |
| SECONDARY Percentage of Subjects Who Achieve Clinical Response (Reduction in CDAI Scores of at Least 100 Points) at Week 4 |
18.8; 36.7; 32.3 | — |
| SECONDARY Percentage of Subjects Who Achieve Clinical Response (Reduction in CDAI Scores of at Least 100 Points) at Week 6 |
21.9; 36.7; 41.9 | — |
| SECONDARY Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 2 |
171.3; 166.1; 169.7 | — |
| SECONDARY Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 4 |
172.6; 169.4; 170.3 | — |
| SECONDARY Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 6 |
173.1; 165.6; 170.8 | — |
| SECONDARY Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 2 |
54.4; 53.4; 54.7; 22.4; 22.4; 22.7 | — |
| SECONDARY Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 4 |
55.4; 54.0; 55.5; 23.3; 23.4; 22.9 | — |
| SECONDARY Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 6 |
55.4; 51.8; 55.8; 23.3; 22.4; 23.4 | — |
| SECONDARY Concentration of C-reactive Protein (CRP) Value at Week 2 |
22.15; 13.58; 13.86 | — |
| SECONDARY Concentration of C-reactive Protein (CRP) Value at Week 4 |
23.47; 12.87; 12.02 | — |
| SECONDARY Concentration of C-reactive Protein (CRP) Value at Week 6 |
23.32; 15.10; 12.62 | — |
| SECONDARY C-reactive Protein (CRP) Ratio to Baseline at Week 2 |
0.85; 0.58; 0.50 | — |
| SECONDARY C-reactive Protein (CRP) Ratio to Baseline at Week 4 |
1.04; 0.53; 0.44 | — |
| SECONDARY C-reactive Protein (CRP) Ratio to Baseline at Week 6 |
1.03; 0.63; 0.46 | — |
Summary
This is a multi-centre, randomized, double-blind, dose response clinical study of CDP870 in patients with Crohn's disease.
Eligibility Criteria
Inclusion Criteria
Inclusion Criteria
- Patients who are diagnosed with Crohn's disease (according to the Crohn's disease diagnostic criteria developed by the research group on intractable inflammatory bowel disorders [Shimoyama group, January 25, 2002]) at least 24 weeks before the starting date of the observation period
- Patients with Crohn's Disease Activity Index (CDAI) score ranging from 220 to 450 inclusive during the observation period
- C-reactive protein (CRP) of 1 mg/dL or higher in the laboratory test performed at the start of the observation period
Exclusion Criteria
- Stoma patient
- Patients with a history of severe hypersensitivity or anphylactic reaction to anti-TNF alpha antibody
- Patients who participated in a clinical study with CDP870
- Pregnant or lactating patients, patients of childbearing potential, or patients who will attempt pregnancy during the study period
- Patients who are judged inappropriate for enrollment by the principal investigator or subinvestigators
Exclusion Criteria
Data sourced from ClinicalTrials.gov (NCT00291668). 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.