A follow-on Safety Study in Subjects With Crohn's Disease Who Have Previously Been Withdrawn From the Double-blind Study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] Due to an Exacerbation of Crohn's Disease

UCB Pharma SA310 enrolled

Overview

A follow-on safety study in subjects with Crohn's Disease who have previously been withdrawn from the double-blind study CDP870-031 \[NCT00152490\] or CDP870-032 \[NCT00152425\] due to an exacerbation of Crohn's Disease.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

310

Conditions

Crohn's Disease

Interventions

Certolizumab Pegol (CDP870)BIOLOGICAL

Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360. Up to 84 months of therapy in this study.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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): 1. At least 70 points higher then Baseline (Week 0 CDP870-031 \[NCT00152490\]; Week 6 CDP870 032 \[NCT00152425\] responders) OR 2. 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

Locations (141)

Outcomes

Primary Outcomes

Percentage of Subjects With at Least One Adverse Event (AE) During the Duration of This Study CDP870-034 (up to 84 Months)

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.

Time frame: Up to 84 months from Study Entry (Week 0) to the Study End (Week 362 ) and the Safety Follow-up (Week 372)

Percentage of Subjects With at Least One Serious Adverse Event (SAE) During the Duration of This Study CDP870-034 (up to 84 Months)

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.

Time frame: Up to 84 months from Study Entry (Week 0) to the Study End (Week 362 ) and the Safety Follow-up (Week 372)

Secondary Outcomes

Percentage of Subjects Achieving Harvey Bradshaw Index (HBI) Remission (HBI ≤ 4) at Study Completion Visit or (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.

Time frame: Study Completion Visit (Week 362) / (Early) Withdrawal Visit

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

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.

Data from ClinicalTrials.gov

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45102

Birmingham, Alabama, United States

45028

Huntsville, Alabama, United States

45044

Little Rock, Arkansas, United States

45095

Orange, California, United States

45101

San Francisco, California, United States

45130

Colorado Springs, Colorado, United States

45094

Gainesville, Florida, United States

45005

Hialeah, Florida, United States

45087

Miami, Florida, United States

45004

North Miami Beach, Florida, United States

...and 131 more locations