Corticosteroid Sparing Effect of Certolizumab in Crohn's Disease

Crohn's Disease Clinical Trial

— COSPAR1  

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00349752
• Other study ID #: C87059
• Secondary ID: 2006-003870-88
• Status: Terminated
• Phase: Phase 3
• Start date: November 2006
• Est. completion date: July 2009

Study information

• Verified date: October 2010
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 174
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Biological:
• certolizumab pegol 400 mg
Certolizumab pegol 400 mg provided in solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36. Two vials will be required for each dosing.

Other:
• Placebo
Placebo (commercially available sodium chloride 0.9% (preservative free)) provided for subcutaneous injection in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36. Two vials will be required for each dosing.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Countries where clinical trial is conducted

United States,  Canada,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease.	Week 38
Secondary	Percentage of Subjects With Continuous Remission Off Steroids at Week 38	The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease. A subject with continuous remission off steroids at Week 38 is a subject in remission (CDAI =< 150) from the visit when he stops taking steroids to Week 38 and is off corticosteroids until Week 38.	Week 38
Secondary	Cumulative Percentage of Subjects With Relapse/Treatment Failure at Week 38	A subject with relapse/ treatment failure has a Crohn's Disease Activity Index (CDAI) > 150 and an increase in CDAI of >= 70 points versus Week 0. [The CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease.]	Week 38
Secondary	Time to Relapse/Treatment Failure During the 38-week Double-blind Treatment Period	A subject with relapse/ treatment failure has a Crohn's Disease Activity Index (CDAI) > 150 and an increase in CDAI of >= 70 points versus Week 0. [The CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease.]	During the 38-week double-blind treatment period
Secondary	Per-subject Median Weekly Dose of Corticosteroids Over the 38-week Double-blind Treatment Period	The median weekly dose of corticosteroids is calculated for each subject, and these per-subject median values are further summarized by treatment group. The mean of the per-subject median doses in each treatment group is presented here.	Over the 38-week double-blind treatment period
Secondary	Per-subject Cumulative Dose of Corticosteroids Over the 48-week Study Period	The cumulative dose of corticosteroids over the 48-week study period is calculated for each subject individually. The mean of these values for each treatment group is presented here.	Over the 48-week study period
Secondary	Change From the 6-week run-in Period in Per-subject Median Weekly Dose of Corticosteroids Over the 38-week Double-blind Treatment Period	The run in period lasted a minimum of 1 week and a maximum of 6 weeks. During this period subjects were treated with any dose or type of systemic corticosteroids the Investigator felt was appropriate. To be eligible for study randomization, subjects must have been in remission (CDAI =150 points) and receiving corticosteroids at a dose no higher than 30 mg/day prednisone or equivalent during the week prior to randomization. Subjects who did not meet these criteria were not randomized and were withdrawn from the study.	6-week run-in period, 38-week double-blind treatment period
Secondary	Crohn's Disease Activity Index (CDAI) Score at Week 38	The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Week 38
Secondary	Change From Baseline in CDAI Score at Week 38	The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Week 0, Week 38
Secondary	Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 38	The total IBDQ score will be derived as the sum of the responses (each ranging from 1 to 7) to all 32 questions on the IBDQ and can therefore range from 32 to 224. A higher score indicates a better quality of life. IBDQ remission is defined as a subject having an IBDQ total score >= 170 points.	Week 38
Secondary	Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 38	The total IBDQ score will be derived as the sum of the responses (each ranging from 1 to 7) to all 32 questions on the IBDQ and can therefore range from 32 to 224. A higher scores indicates a better quality of life. IBDQ response is defined as an increase from baseline in the IBDQ total score >= 16 points.	Week 0, Week 38

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