Corticosteroid Sparing Effect of Certolizumab in Crohn's Disease - Full Text View

Sponsor:	UCB, Inc.
Information provided by (Responsible Party):	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT00349752

Purpose

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.

Condition	Intervention	Phase
Crohn's Disease	Biological: certolizumab pegol 400 mg Other: Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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.

Resource links provided by NLM:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

Drug Information available for: Certolizumab pegol Corticosteroids

U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:

Percentage of Subjects Who Have Been Withdrawn From Prednisone or Prednisolone Therapy According to the Corticosteroid Tapering Schedule and Have Remained Off Corticosteroids and in Disease Remission at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 [ Time Frame: Week 38 ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Percentage of Subjects With Continuous Remission Off Steroids at Week 38 [ Time Frame: Week 38 ] [ Designated as safety issue: No ]
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.
Cumulative Percentage of Subjects With Relapse/Treatment Failure at Week 38 [ Time Frame: Week 38 ] [ Designated as safety issue: No ]
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.]
Time to Relapse/Treatment Failure During the 38-week Double-blind Treatment Period [ Time Frame: During the 38-week double-blind treatment period ] [ Designated as safety issue: No ]
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.]
Per-subject Median Weekly Dose of Corticosteroids Over the 38-week Double-blind Treatment Period [ Time Frame: Over the 38-week double-blind treatment period ] [ Designated as safety issue: No ]
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.
Per-subject Cumulative Dose of Corticosteroids Over the 48-week Study Period [ Time Frame: Over the 48-week study period ] [ Designated as safety issue: No ]
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.
Change From the 6-week run-in Period in Per-subject Median Weekly Dose of Corticosteroids Over the 38-week Double-blind Treatment Period [ Time Frame: 6-week run-in period, 38-week double-blind treatment period ] [ Designated as safety issue: No ]
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.
Crohn's Disease Activity Index (CDAI) Score at Week 38 [ Time Frame: Week 38 ] [ Designated as safety issue: No ]
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.
Change From Baseline in CDAI Score at Week 38 [ Time Frame: Week 0, Week 38 ] [ Designated as safety issue: No ]
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.
Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 38 [ Time Frame: Week 38 ] [ Designated as safety issue: No ]
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.
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 38 [ Time Frame: Week 0, Week 38 ] [ Designated as safety issue: No ]
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.

Enrollment:	174
Study Start Date:	November 2006
Study Completion Date:	July 2009
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Certolizumab pegol 400 mg Certolizumab pegol 400 mg	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 Names: Cimzia CDP870 CZP
Placebo Comparator: Placebo Placebo	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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00349752

Show 68 Study Locations

Sponsors and Collaborators

UCB, Inc.

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

More Information

Additional Information:

Product Information This link exits the ClinicalTrials.gov site

FDA Safety Alerts and Recalls This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT00349752 History of Changes
Other Study ID Numbers:	C87059
Study First Received:	June 30, 2006
Results First Received:	July 1, 2010
Last Updated:	August 30, 2011
Health Authority:	United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices; Canada: Health Canada

Keywords provided by UCB, Inc.:

certolizumab pegol
Cimzia
Crohn's Disease
Inflammatory Bowel Disease

Additional relevant MeSH terms:

Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

Intestinal Diseases
Immunoglobulin Fab Fragments
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012