A Study to Test the Effect of CDP870 in the Treatment of Crohn's Disease Over 26 Weeks, Comparing CDP870 to a Dummy Drug (Placebo) - Full Text View

Purpose

A 26 week study to examine the efficacy, safety and pharmacokinetics of CDP870 in Crohn's disease

Condition	Intervention	Phase
Crohn's Disease	Drug: Certolizumab Pegol (CDP870)	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind
Official Title:	A Phase III Multi-national, Multi-centre, Double-blind Placebo-controlled Parallel Group, 26 Week Study to Assess the Safety and Efficacy of the Humanised Anti-TNF PEG Conjugate, CDP870 400 mg sc, (Dosed at Weeks 0, 2, 4 Then 4-weekly to Week 24), in the Treatment of Patients With Active 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

U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:

In the population with CRP ≥ 10 mg/L at baseline
Clinical response at week 6
Clinical response at week 6 and week 26

Secondary Outcome Measures:

In the population with CRP ≥ 10 mg/L at baseline - % patients in clinical remission at Week 6; % patients in clinical remission at both Week 6 and Week 26; % patients with IBDQ response at Week 6; % patients with IBDQ response at both Week 6 and Week 2

Estimated Enrollment:	604
Study Start Date:	December 2003
Study Completion Date:	May 2005
Primary Completion Date:	May 2005 (Final data collection date for primary outcome measure)

Detailed Description:

Receiving immunosuppressants (azathioprine/6-MP/methotrexate) at Week 0 or not.

604 patients will be enrolled with 1006 patients screened (to allow for 25% screen failures between screening and Week 0 and expected presentation at Screening of 60% of patients with CRP < 10 mg/L and 40% of patients with CRP ≥ 10 mg/L).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Definitive diagnosis of Crohn's disease confirmed (at least 3 months prior to study entry) either by radiological, endoscopic or histological evidence, affecting the terminal ileum (L1), colon (L2) or ileocolon (L3*. *Vienna Classification (1998)
Active Crohn's disease (≥ 220 and ≤ 450) scored over the 7 days prior to the first dose of study drug.
Male and female aged 18 years or above at screening.
Patients who meet all concomitant medication criteria in the protocol specified table. For all drugs being taken at screening, the patient should be able to remain on a stable dose throughout the duration of the study, although steroids may be tapered starting at Weeks 8 to 12.

Exclusion Criteria:

Crohn's Disease Related
Fistula abscess present at screening.
Stricturing type disease with symptoms or signs of non-inflammatory mechanical obstruction or bowel perforation in last 3 months.
Short bowel syndrome.
Functional colostomy or ileostomy (note: patients who have had a temporary stoma in the past, which has been reversed, are eligible to enter the study).
Positive stool laboratory results for enteric pathogens.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00152490

Sponsors and Collaborators

UCB, Inc.

Investigators

Study Director:

UCB Clinical Trial Call Center

UCB, Inc.

More Information

Publications:

Sandborn WJ, Feagan BG, Stoinov S, Honiball PJ, Rutgeerts P, Mason D, Bloomfield R, Schreiber S; PRECISE 1 Study Investigators. Certolizumab pegol for the treatment of Crohn's disease. N Engl J Med. 2007 Jul 19;357(3):228-38.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lewis JD. Anti-TNF antibodies for Crohn's disease--in pursuit of the perfect clinical trial. N Engl J Med. 2007 Jul 19;357(3):296-8. No abstract available.

ClinicalTrials.gov Identifier:	NCT00152490 History of Changes
Other Study ID Numbers:	C87031
Study First Received:	September 8, 2005
Last Updated:	February 22, 2010
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration Austria: Federal Ministry for Health and Women Belarus: Ministry of Health Belgium: Directorate general for the protection of Public health: Medicines Bulgaria: Bulgarian Drug Agency Canada: Health Canada Czech Republic: State Institute for Drug Control Estonia: The State Agency of Medicine Georgia: Ministry of Health Germany: Paul-Ehrlich-Institut Hong Kong: Department of Health Hungary: National Institute of Pharmacy Italy: Ministry of Health Latvia: State Agency of Medicines Norway: Norwegian Medicines Agency Poland: Ministry of Health Russia: Pharmacological Committee, Ministry of Health Slovenia: Agency for Medicinal Products - Ministry of Health South Africa: Medicines Control Council Sweden: Medical Products Agency Ukraine: State Pharmacological Center - Ministry of Health United States: Food and Drug Administration

Keywords provided by UCB, Inc.:

Crohn's disease, CDP870, CDAI, clinical response, remission,
Certolizumab Pegol, Cimzia

Additional relevant MeSH terms:

Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

Intestinal Diseases
Immunoglobulin Fab Fragments
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013