Corticosteroid Sparing Effect of Certolizumab - Full Text View

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

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.

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:

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Compare certolizumab pegol and placebo treatments in patients successfully withdrawn from prednisone or prednisolone: tapering schedule of the protocol, remained off corticosteroids, in disease remission (CDAI≤150 at week 36 of treatment.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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of patients with continuous remission [ Time Frame: duration of trial ] [ Designated as safety issue: No ]
Proportion of patients with relapse [ Time Frame: duration of trial ] [ Designated as safety issue: No ]
Time to relapse [ Time Frame: duration of trial ] [ Designated as safety issue: No ]
Corticosteroids use over the duration of the study [ Time Frame: duration of the trial ] [ Designated as safety issue: No ]
Safety [ Time Frame: duration of the trial ] [ Designated as safety issue: No ]

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

Arms	Assigned Interventions
CDP870: 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.
Placebo: 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

Show 71 Study Locations

Sponsors and Collaborators

UCB

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

More Information

No publications provided

Responsible Party:	UCB ( Study Director )
Study ID Numbers:	C87059, CDP870/C87059, COSPAR I
Study First Received:	June 30, 2006
Last Updated:	March 26, 2009
ClinicalTrials.gov Identifier:	NCT00349752 History of Changes
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:

Immunoglobulin Fab Fragments
Crohn's Disease
Immunologic Factors
Ileitis
Gastrointestinal Diseases
Enteritis
Inflammatory Bowel Diseases
Intestinal Diseases

Ileal Diseases
Antibodies
Digestive System Diseases
Crohn Disease
Gastroenteritis
Colitis
Immunoglobulins

Additional relevant MeSH terms:

Immunoglobulin Fab Fragments
Immunologic Factors
Ileitis
Gastrointestinal Diseases
Enteritis
Physiological Effects of Drugs
Inflammatory Bowel Diseases

Intestinal Diseases
Ileal Diseases
Pharmacologic Actions
Digestive System Diseases
Crohn Disease
Gastroenteritis

ClinicalTrials.gov processed this record on July 06, 2009