Corticosteroid Sparing Effect of Certolizumab in Crohn's Disease (COSPAR1)

July 10, 2018 updated by: UCB Pharma

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.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

174

Phase

  • Phase 3

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada
      • Edmonton, Alberta, Canada
    • British Columbia
      • Abbotsford, British Columbia, Canada
      • Vancouver, British Columbia, Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
    • Ontario
      • London, Ontario, Canada
      • Toronto, Ontario, Canada
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada
  • Germany
      • Frankfurt, Germany
      • Heidleberg, Germany
      • Jena, Germany
      • Magdeburg, Germany
      • Ulm, Germany
  • United States
    • Alabama
      • Birmingham, Alabama, United States
      • Montgomery, Alabama, United States
    • Arizona
      • Tucson, Arizona, United States
    • California
      • La Jolla, California, United States
      • Oceanside, California, United States
      • Orange, California, United States
      • Palo Alto, California, United States
      • Roseville, California, United States
    • Colorado
      • Golden, Colorado, United States
    • Florida
      • Clearwater, Florida, United States
      • Gainesville, Florida, United States
      • Hialeah, Florida, United States
      • Jacksonville, Florida, United States
      • North Miami Beach, Florida, United States
      • Sarasota, Florida, United States
      • Winter Park, Florida, United States
    • Georgia
      • Marietta, Georgia, United States
      • Savannah, Georgia, United States
    • Illinois
      • Chicago, Illinois, United States
    • Indiana
      • Bloomington, Indiana, United States
    • Kansas
      • Topeka, Kansas, United States
    • Kentucky
      • Bowling Green, Kentucky, United States
      • Louisville, Kentucky, United States
    • Louisiana
      • Metairie, Louisiana, United States
    • Maryland
      • Annapolis, Maryland, United States
    • Massachusetts
      • Newton, Massachusetts, United States
    • Michigan
      • Chesterfield, Michigan, United States
      • Dearborn, Michigan, United States
      • Troy, Michigan, United States
    • Minnesota
      • Rochester, Minnesota, United States
    • Mississippi
      • Ocean Springs, Mississippi, United States
    • Missouri
      • Kansas City, Missouri, United States
      • Mexico, Missouri, United States
    • New York
      • New York, New York, United States
      • Syracuse, New York, United States
    • North Carolina
      • Chapel Hill, North Carolina, United States
      • Charlotte, North Carolina, United States
      • Raleigh, North Carolina, United States
    • Ohio
      • Cincinnati, Ohio, United States
      • Cleveland, Ohio, United States
      • Dayton, Ohio, United States
    • Oklahoma
      • Tulsa, Oklahoma, United States
    • South Carolina
      • Columbia, South Carolina, United States
    • Tennessee
      • Germantown, Tennessee, United States
    • Texas
      • Austin, Texas, United States
      • Irving, Texas, United States
    • Utah
      • Salt Lake City, Utah, United States
    • Vermont
      • Burlington, Vermont, United States
    • Virginia
      • Chesapeake, Virginia, United States
      • Richmond, Virginia, United States
    • Washington
      • Seattle, Washington, United States
    • Wisconsin
      • Madison, Wisconsin, United States
      • Milwaukee, Wisconsin, United States
      • Monroe, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 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.
Experimental: 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
  • CZP
  • CDP870

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Subjects With Continuous Remission Off Steroids at Week 38
Time Frame: 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
Cumulative Percentage of Subjects With Relapse/Treatment Failure at Week 38
Time Frame: 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
Time to Relapse/Treatment Failure During the 38-week Double-blind Treatment Period
Time Frame: 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
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
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
Per-subject Cumulative Dose of Corticosteroids Over the 48-week Study Period
Time Frame: 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
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
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
Crohn's Disease Activity Index (CDAI) Score at Week 38
Time Frame: 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
Change From Baseline in CDAI Score at Week 38
Time Frame: Week 0, 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
Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 38
Time Frame: 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
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 38
Time Frame: Week 0, 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Pharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

June 30, 2006

First Submitted That Met QC Criteria

July 6, 2006

First Posted (Estimate)

July 10, 2006

Study Record Updates

Last Update Posted (Actual)

August 9, 2018

Last Update Submitted That Met QC Criteria

July 10, 2018

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C87059
  • 2006-003870-88 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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