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

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ClinicalTrials.gov Identifier: NCT00349752
Recruitment Status : Terminated (Recruitment was stopped early due to slow enrolment of this population. With no safety concerns, the study continued normally for subjects already recruited)
First Posted : July 10, 2006
Results First Posted : December 1, 2010
Last Update Posted : September 5, 2014
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

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.

Condition or disease Intervention/treatment Phase
Crohn's Disease Biological: certolizumab pegol 400 mg Other: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 174 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.
Study Start Date : November 2006
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.]

  3. 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.]

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00349752


  Show 68 Study Locations
Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)

Additional Information:
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00349752     History of Changes
Other Study ID Numbers: C87059
2006-003870-88 ( EudraCT Number )
First Posted: July 10, 2006    Key Record Dates
Results First Posted: December 1, 2010
Last Update Posted: September 5, 2014
Last Verified: October 2010

Keywords provided by UCB Pharma:
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
Certolizumab Pegol
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents