Clinical trial NCT00349752: Corticosteroid Sparing Effect of Certolizumab in Crohn's Disease
Official title: A Phase IIIb Multicenter, Double-blind, Placebo-controlled,Randomized Trial to Examine the Corticosteroid-sparing Effect of Certolizumab Pegol in Patients With Moderate to Severe Crohn's Disease.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Crohn's Disease
Keywords: certolizumab pegol
Cimzia
Crohn's Disease
Inflammatory Bowel Disease
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2006-07-10
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The current study is designed to measure the corticosteroid-sparing effect of certolizumab pegol using a defined schedule of corticosteroid tapering in subjects with moderate to severe Crohn's disease. Subjects had to be in remission (CDAI\<=150) and receiving corticosteroids at a dose no higher than 30 mg/day prednisone or equivalent during the week prior to randomization.


Eligibility criteria: Inclusion Criteria:

* Men and women
* Age 18 years or older with moderate to severe Crohn's disease (Crohn's Disease Activity Index (CDAI) score of ≥ 220 ≤450)

Exclusion Criteria:

* Active or draining fistula present at screening
* Lactating and/or pregnant female subjects
* A history of any health condition that could potentially interfere with the disease and/or the treatment
* A history of an adverse reaction to polyethylene glycol (PEG) or a protein medicinal product
* Any other condition which in the Investigator's judgment would make the patient unsuitable for inclusion in the study
* History of drug or alcohol abuse in the prior year
* Receipt of any experimental therapy within or outside a clinical trial in the 3 months prior to Visit 0

Primary outcomes:
measure: Percentage of Subjects Who Have Been Withdrawn From Prednisone or Prednisolone Therapy According to the Corticosteroid Tapering Schedule and Have Remained Off Corticosteroids and in Disease Remission at Week 38
timeFrame: Week 38
Secondary outcomes:
measure: Percentage of Subjects With Continuous Remission Off Steroids at Week 38
timeFrame: Week 38
measure: Cumulative Percentage of Subjects With Relapse/Treatment Failure at Week 38
timeFrame: Week 38
measure: Time to Relapse/Treatment Failure During the 38-week Double-blind Treatment Period
timeFrame: During the 38-week double-blind treatment period
measure: Per-subject Median Weekly Dose of Corticosteroids Over the 38-week Double-blind Treatment Period
timeFrame: Over the 38-week double-blind treatment period
measure: Per-subject Cumulative Dose of Corticosteroids Over the 48-week Study Period
timeFrame: Over the 48-week study period
measure: Change From the 6-week run-in Period in Per-subject Median Weekly Dose of Corticosteroids Over the 38-week Double-blind Treatment Period
timeFrame: 6-week run-in period, 38-week double-blind treatment period
measure: Crohn's Disease Activity Index (CDAI) Score at Week 38
timeFrame: Week 38
measure: Change From Baseline in CDAI Score at Week 38
timeFrame: Week 0, Week 38
measure: Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 38
timeFrame: Week 38
measure: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 38
timeFrame: Week 0, Week 38
Other outcomes:
Locations:
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city: Vancouver
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city: London
country: Canada
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city: Toronto
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country: Canada
state: Saskatchewan
city: Frankfurt
country: Germany
city: Heidleberg
country: Germany
city: Jena
country: Germany
city: Magdeburg
country: Germany
city: Ulm
country: Germany
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: