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]

Phase 3

Completed

Conditions: Crohn's Disease

Registration Number: NCT00160524

Lead Sponsor: UCB Pharma SA

Brief 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 \[NCT00152425\]).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 596

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With at Least One Adverse Event (AE) During the Duration of the Study CDP870-033 (up to 84 Months)	Up to 84 months from Study Entry (Week 0) to the Study End (Week 364) and the Safety Follow-up (Week 374)	An AE is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Percentage of Subjects With at Least One Serious Adverse Event (SAE) During the Duration of This Study CDP870-033 (up to 84 Months)	Up to 84 months from Study Entry (Week 0) to the Study End (Week 364) and the Safety Follow-up (Week 374)	An SAE is defined as any untoward medical occurrence that occurs at any dose which results in death, is life threatening, requires hospitalization, results in persistent/significant disability/incapacity, is an infection that requires parenteral antibiotics, is a congenital anomaly/birth defect, or is an important medical event.

Secondary Outcome Measures

Name	Time	Method
Plasma Concentration of Certolizumab Pegol at Study Completion Visit or (Early) Withdrawal Visit	Study Completion Visit (Week 364) / (Early) Withdrawal Visit	Plasma samples for determination of Certolizumab Pegol were taken prior to Certolizumab Pegol administration.
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	From Week 0 of study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] to Study Completion Visit (Week 364) of CDP870-033 (up to 90 months)	Subjects are counted as antibody positive to Certolizumab Pegol if they have at least one positive result from Week 0 in one of the previous studies CDP870-031 \[NCT00152490\] or CDP870-032 \[NCT00152425\] to the Last Visit in this study. A positive result is defined as Anti-CZP antibody levels \> 2.4 units/mL.
C-Reactive Protein (CRP) Level at Study Completion Visit or (Early) Withdrawal Visit	Study Completion Visit (Week 364) / (Early) Withdrawal Visit
Percentage of Subjects Achieving Harvey Bradshaw Index (HBI) Remission (HBI ≤ 4) at Study Completion Visit or (Early) Withdrawal Visit	Study Completion Visit (Week 364) / (Early) Withdrawal Visit	HBI remission is defined as total HBI score of 4 points or less. HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (8 items, score 1 per item) lower scores indicating better well being. The first three parameters are scored for the previous day.
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	From Week 0 of study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] to Study Completion Visit (Week 364) of this study (up to 90 months) or (Early) Withdrawal Visit	Response is defined as decrease in total Harvey Bradshaw Index (HBI) score of 3 or more points. HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (8 items, score 1 per item) lower scores indicating better well-being. The first three parameters are scored for the previous day.
Faecal Calprotectin Level at Week 258 Visit or (Early) Withdrawal Visit, if it is Earlier Than Week 258	Week 258 / (Early) Withdrawal Visit, if it is earlier than Week 258

Trial Locations

Locations (206): 45102
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Birmingham, Alabama, United States
45028
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Huntsville, Alabama, United States
45144
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Tucson, Arizona, United States
45095
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Orange, California, United States
45006
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San Diego, California, United States
45131
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San Diego, California, United States
45130
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Colorado Springs, Colorado, United States
45094
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Gainesville, Florida, United States
45029
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Jacksonville, Florida, United States
45087
🇺🇸
Miami, Florida, United States
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45102
🇺🇸Birmingham, Alabama, United States