Phase 3
N=310
A follow-on Safety Study in Subjects With Crohn's Disease Who Have Previously Been Withdrawn From the Double-blind Study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] Due to an Exacerbation of Crohn's Disease
Crohn's Disease
Bottom Line
View on ClinicalTrials.gov: NCT00160706 ↗Enrolled (actual)
310
Serious AEs
44.5%
Results posted
Jul 2013
Primary outcome: Primary: Percentage of Subjects With at Least One Adverse Event (AE) During the Duration of This Study CDP870-034 (up to 84 Months) — 94.2 percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Certolizumab Pegol (CDP870) (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- UCB Pharma SA
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With at Least One Adverse Event (AE) During the Duration of This Study CDP870-034 (up to 84 Months) |
94.2 | — |
| PRIMARY Percentage of Subjects With at Least One Serious Adverse Event (SAE) During the Duration of This Study CDP870-034 (up to 84 Months) |
44.5 | — |
| SECONDARY Percentage of Subjects Achieving Harvey Bradshaw Index (HBI) Remission (HBI ≤ 4) at Study Completion Visit or (Early) Withdrawal Visit |
34.6 | — |
| SECONDARY Percentage of Subjects in Harvey Bradshaw Index (HBI) Response (HBI Change ≥ 3) at Study Completion Visit or (Early) Withdrawal Visit From Week 0 of Feeder Study CDP870-031 or CDP870-032 |
52.8 | — |
| SECONDARY Percentage of Subjects in Harvey Bradshaw Index (HBI) Response (HBI Change ≥ 3) at Study Completion Visit or (Early) Withdrawal Visit From Week 0 of CDP870-034 |
65.6 | — |
| SECONDARY Plasma Concentration of Certolizumab Pegol at Study Completion Visit or (Early) Withdrawal Visit |
5.870 | — |
| SECONDARY Percentage of Subjects With Positive Anti-CZP Anti-body Status at Any Time From Week 0 of the Feeder Studies CDP870-031 or CDP870-032 to the Study Completion Visit in CDP870-034 |
23.6 | — |
| SECONDARY C-Reactive Protein (CRP) Level at Study Completion Visit or (Early) Withdrawal Visit |
10.78 | — |
| SECONDARY Fecal Calprotectin Level at Week 256 or (Early) Withdrawal Visit, if it is Earlier Than Week 256 |
460.784 | — |
Summary
A follow-on safety study in subjects with Crohn's Disease who have previously been withdrawn from the double-blind study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] due to an exacerbation of Crohn's Disease.
Eligibility Criteria
Inclusion Criteria
- Participation in either of the CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] clinical studies in which the subject completed the Week 2 assessment in CDP870-031 [NCT00152490] or the Week 6 randomization in CDP870-032 [NCT00152425] but whose Crohn's Disease was significantly worse as determined by the investigator and whose Clinical Disease Activity Index (CDAI) score at entry to this study is either (subjects may have received active or placebo treatment):
- At least 70 points higher then Baseline (Week 0 CDP870-031 [NCT00152490]; Week 6 CDP870 032 [NCT00152425] responders) OR
- Higher than Baseline (Week 0 CDP870-031 [NCT00152490]; Week 6 CDP870-032 [NCT00152425] responders) with an absolute score of at least 350 points
- Subjects must be able to understand the information provided to them and give written informed consent
Exclusion Criteria
- Any exclusion criterion that would have prevented the subject's participation in the qualifying pivotal study (CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425]), although the upper limit of 450 in the CDAI score is not applicable. In addition the criterion that excludes previous participation in a clinical trial of Certolizumab Pegol does not apply
Data sourced from ClinicalTrials.gov (NCT00160706). 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.