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Corticosteroid Sparing Effect of Certolizumab

This study is currently recruiting participants.
Verified by UCB, August 2008

Sponsored by: UCB
Information provided by: UCB
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 patients with moderate to severe Crohn's disease.


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

Genetics Home Reference related topics:   Crohn disease   

MedlinePlus related topics:   Crohn's Disease   

ChemIDplus related topics:   Corticosteroids    Certolizumab pegol   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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.

Further study details as provided by UCB:

Primary Outcome Measures:
  • Compare certolizumab pegol and placebo treatments in patients successfully withdrawn from prednisone or prednisolone: tapering schedule of the protocol, remained off corticosteroids, in disease remission (CDAI≤150 at week 36 of treatment. [ Time Frame: duration of trial ]

Secondary Outcome Measures:
  • Proportion of patients with continuous remission [ Time Frame: duration of trial ]
  • Proportion of patients with relapse [ Time Frame: duration of trial ]
  • Time to relapse [ Time Frame: duration of trial ]
  • Corticosteroids use over the duration of the study [ Time Frame: duration of the trial ]
  • Safety [ Time Frame: duration of the trial ]

Estimated Enrollment:   440
Study Start Date:   September 2006
Estimated Study Completion Date:   August 2009
Estimated Primary Completion Date:   August 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
Certolizumab pegol
Biological: certolizumab pegol
400 mg liquid CP administered as 2 subcutaneous injections of 200mg every 2 weeks for the first three injections and then every 4 weeks for the duration of the trial.
2: Placebo Comparator Other: Placebo
placebo administered as 2 x 1ml subcutaneous injections every 2 weeks for the first three injections and then every 4 weeks for the duration of the trial

  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 (CDAI score of ≥ 220 ≤450).

Exclusion Criteria:

  • Active or draining fistula present at screening.
  • Lactating and/or pregnant female patients.
  • 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

Contacts
Contact: UCB Clinical Trial Call Center     +1 877 822 9493    

Show 101 study locations  Show 101 Study Locations

Sponsors and Collaborators
UCB

Investigators
Study Director:     UCB Clinical Trial Call Center     +1 877 822 9493 (UCB)    
  More Information

Responsible Party:   UCB ( Study Director )
Study ID Numbers:   C87059, CDP870/C87059, COSPAR I
First Received:   June 30, 2006
Last Updated:   August 12, 2008
ClinicalTrials.gov Identifier:   NCT00349752
Health Authority:   United States: Food and Drug Administration;   Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by UCB:
certolizumab pegol (Cimzia)  
Crohn's Disease  
Inflammatory Bowel Disease  
Ileitis  
Colitis
Enteritis
Ileocolitis

Study placed in the following topic categories:
Digestive System Diseases
Gastrointestinal Diseases
Ileitis
Enteritis
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Intestinal Diseases
Colitis

ClinicalTrials.gov processed this record on August 20, 2008




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