Phase 3 N=595 Treatment

A follow-on Safety Study of CDP870 in Subjects With Crohn's Disease (CD) Who Have Completed a 26-week Double Blind Study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425]

Crohn's Disease

Bottom Line

View on ClinicalTrials.gov: NCT00160524 ↗

Enrolled (actual)

595

Serious AEs

40.3%

Results posted

Oct 2013

Primary outcome: Primary: Percentage of Subjects With at Least One Adverse Event (AE) During the Duration of the Study CDP870-033 (up to 84 Months) — 88.2 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: Aug 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Subjects With at Least One Adverse Event (AE) During the Duration of the Study CDP870-033 (up to 84 Months)	88.2	—
PRIMARY Percentage of Subjects With at Least One Serious Adverse Event (SAE) During the Duration of This Study CDP870-033 (up to 84 Months)	40.3	—
SECONDARY Percentage of Subjects Achieving Harvey Bradshaw Index (HBI) Remission (HBI ≤ 4) at Study Completion Visit or (Early) Withdrawal Visit	54.7	—
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	21.7	—
SECONDARY Plasma Concentration of Certolizumab Pegol at Study Completion Visit or (Early) Withdrawal Visit	5.578	—
SECONDARY Percentage of Subjects With Positive Anti-CZP Anti-body Status at Any Time From Week 0 of the Feeder Study CDP870-031 or CDP870-032 to the Study Completion Visit in CDP870-033	22.6	—
SECONDARY C-Reactive Protein (CRP) Level at Study Completion Visit or (Early) Withdrawal Visit	7.93	—
SECONDARY Faecal Calprotectin Level at Week 258 Visit or (Early) Withdrawal Visit, if it is Earlier Than Week 258	302.540	—

Summary

An open-label follow-on safety study of CDP870 (400 mg every 4 weeks) in patients with Crohn's Disease who have completed a 26-week blinded study (CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425]).

Eligibility Criteria

Inclusion Criteria

Participation in either of the CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] clinical studies in which the subject completed the trial at Week 26. Subjects may have received active or placebo or both treatments in the prior study
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 criterion that excludes previous participation in a clinical trial of Certolizumab Pegol does not apply. In addition there are no limits on the Clinical Disease Activity Index (CDAI) score at entry

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00160524). 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.