Back to resultsCorticosteroid Sparing Effect of Certolizumab in Crohn's Disease (COSPAR1)
Primary Purpose
Crohn's Disease
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
certolizumab pegol 400 mg
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Crohn's Disease focused on measuring certolizumab pegol, Cimzia, Crohn's Disease, Inflammatory Bowel Disease
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Certolizumab pegol 400 mg
Placebo
Arm Description
Certolizumab pegol 400 mg
Placebo
Outcomes
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Percentage of Subjects Who Have Been Withdrawn From Prednisone or Prednisolone Therapy According to the Corticosteroid Tapering Schedule and Have Remained Off Corticosteroids and in Disease Remission at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
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
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
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
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
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
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
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
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
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
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00349752
Brief Title
Corticosteroid Sparing Effect of Certolizumab in Crohn's Disease
Acronym
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.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Terminated
Why Stopped
Recruitment was stopped early due to slow enrolment of this population. With no safety concerns, the study continued normally for subjects already recruited
Study Start Date
November 2006 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Pharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
certolizumab pegol, Cimzia, Crohn's Disease, Inflammatory Bowel Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
174 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Certolizumab pegol 400 mg
Arm Type
Experimental
Arm Description
Certolizumab pegol 400 mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Biological
Intervention Name(s)
certolizumab pegol 400 mg
Other Intervention Name(s)
Cimzia, CDP870, CZP
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Week 38
Secondary Outcome Measure Information:
Title
Percentage of Subjects With Continuous Remission Off Steroids at Week 38
Description
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.
Time Frame
Week 38
Title
Cumulative Percentage of Subjects With Relapse/Treatment Failure at Week 38
Description
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 Frame
Week 38
Title
Time to Relapse/Treatment Failure During the 38-week Double-blind Treatment Period
Description
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 Frame
During the 38-week double-blind treatment period
Title
Per-subject Median Weekly Dose of Corticosteroids Over the 38-week Double-blind Treatment Period
Description
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.
Time Frame
Over the 38-week double-blind treatment period
Title
Per-subject Cumulative Dose of Corticosteroids Over the 48-week Study Period
Description
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.
Time Frame
Over the 48-week study period
Title
Change From the 6-week run-in Period in Per-subject Median Weekly Dose of Corticosteroids Over the 38-week Double-blind Treatment Period
Description
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.
Time Frame
6-week run-in period, 38-week double-blind treatment period
Title
Crohn's Disease Activity Index (CDAI) Score at Week 38
Description
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.
Time Frame
Week 38
Title
Change From Baseline in CDAI Score at Week 38
Description
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.
Time Frame
Week 0, Week 38
Title
Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 38
Description
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.
Time Frame
Week 38
Title
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 38
Description
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.
Time Frame
Week 0, Week 38
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
+1 877 822 9493 (UCB)
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
Country
United States
City
Montgomery
State/Province
Alabama
Country
United States
City
Tucson
State/Province
Arizona
Country
United States
City
La Jolla
State/Province
California
Country
United States
City
Oceanside
State/Province
California
Country
United States
City
Orange
State/Province
California
Country
United States
City
Palo Alto
State/Province
California
Country
United States
City
Roseville
State/Province
California
Country
United States
City
Golden
State/Province
Colorado
Country
United States
City
Clearwater
State/Province
Florida
Country
United States
City
Gainesville
State/Province
Florida
Country
United States
City
Hialeah
State/Province
Florida
Country
United States
City
Jacksonville
State/Province
Florida
Country
United States
City
North Miami Beach
State/Province
Florida
Country
United States
City
Sarasota
State/Province
Florida
Country
United States
City
Winter Park
State/Province
Florida
Country
United States
City
Marietta
State/Province
Georgia
Country
United States
City
Savannah
State/Province
Georgia
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Bloomington
State/Province
Indiana
Country
United States
City
Topeka
State/Province
Kansas
Country
United States
City
Bowling Green
State/Province
Kentucky
Country
United States
City
Louisville
State/Province
Kentucky
Country
United States
City
Metairie
State/Province
Louisiana
Country
United States
City
Annapolis
State/Province
Maryland
Country
United States
City
Newton
State/Province
Massachusetts
Country
United States
City
Chesterfield
State/Province
Michigan
Country
United States
City
Dearborn
State/Province
Michigan
Country
United States
City
Troy
State/Province
Michigan
Country
United States
City
Rochester
State/Province
Minnesota
Country
United States
City
Ocean Springs
State/Province
Mississippi
Country
United States
City
Kansas City
State/Province
Missouri
Country
United States
City
Mexico
State/Province
Missouri
Country
United States
City
New York
State/Province
New York
Country
United States
City
Syracuse
State/Province
New York
Country
United States
City
Chapel Hill
State/Province
North Carolina
Country
United States
City
Charlotte
State/Province
North Carolina
Country
United States
City
Raleigh
State/Province
North Carolina
Country
United States
City
Cincinnati
State/Province
Ohio
Country
United States
City
Cleveland
State/Province
Ohio
Country
United States
City
Dayton
State/Province
Ohio
Country
United States
City
Tulsa
State/Province
Oklahoma
Country
United States
City
Columbia
State/Province
South Carolina
Country
United States
City
Germantown
State/Province
Tennessee
Country
United States
City
Austin
State/Province
Texas
Country
United States
City
Irving
State/Province
Texas
Country
United States
City
Salt Lake City
State/Province
Utah
Country
United States
City
Burlington
State/Province
Vermont
Country
United States
City
Chesapeake
State/Province
Virginia
Country
United States
City
Richmond
State/Province
Virginia
Country
United States
City
Seattle
State/Province
Washington
Country
United States
City
Madison
State/Province
Wisconsin
Country
United States
City
Milwaukee
State/Province
Wisconsin
Country
United States
City
Monroe
State/Province
Wisconsin
Country
United States
City
Calgary
State/Province
Alberta
Country
Canada
City
Edmonton
State/Province
Alberta
Country
Canada
City
Abbotsford
State/Province
British Columbia
Country
Canada
City
Vancouver
State/Province
British Columbia
Country
Canada
City
Winnipeg
State/Province
Manitoba
Country
Canada
City
Halifax
State/Province
Nova Scotia
Country
Canada
City
London
State/Province
Ontario
Country
Canada
City
Toronto
State/Province
Ontario
Country
Canada
City
Saskatoon
State/Province
Saskatchewan
Country
Canada
City
Frankfurt
Country
Germany
City
Heidleberg
Country
Germany
City
Jena
Country
Germany
City
Magdeburg
Country
Germany
City
Ulm
Country
Germany
12. IPD Sharing Statement
Links:
URL
http://www.fda.gov/Safety/Recalls/default.htm
Description
FDA Safety Alerts and Recalls
Learn more about this trial
Corticosteroid Sparing Effect of Certolizumab in Crohn's Disease
We'll reach out to this number within 24 hrs