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)

Crohn's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00152490
• Other study ID #: C87031
• Status: Completed
• Phase: Phase 3
• First received: September 8, 2005
• Last updated: September 6, 2013
• Start date: December 2003
• Est. completion date: May 2005

Study information

• Verified date: February 2010
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationAustria: Federal Ministry for Health and WomenBelarus: Ministry of HealthBelgium: Federal Agency for Medicines and Health Products, FAMHPBulgaria: Bulgarian Drug AgencyCanada: Health CanadaCzech Republic: State Institute for Drug ControlEstonia: The State Agency of MedicineGeorgia: Ministry of HealthGermany: Paul-Ehrlich-InstitutHong Kong: Department of HealthHungary: National Institute of PharmacyItaly: Ministry of HealthLatvia: State Agency of MedicinesNorway: Norwegian Medicines AgencyPoland: Ministry of HealthRussia: Pharmacological Committee, Ministry of HealthSlovenia: Agency for Medicinal Products - Ministry of HealthSouth Africa: Medicines Control CouncilSweden: Medical Products AgencyUkraine: State Pharmacological Center - Ministry of HealthUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 604
• Est. completion date: May 2005
• Est. primary completion date: May 2005
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• Certolizumab Pegol (CDP870)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

References & Publications (3)

Reilly MC, Gerlier L, Brabant Y, Brown M. Validity, reliability, and responsiveness of the work productivity and activity impairment questionnaire in Crohn's disease. Clin Ther. 2008 Feb;30(2):393-404. doi: 10.1016/j.clinthera.2008.02.016. — View Citation

Rutgeerts P, Schreiber S, Feagan B, Keininger DL, O'Neil L, Fedorak RN; CDP870 Crohn's Disease Study Group. Certolizumab pegol, a monthly subcutaneously administered Fc-free anti-TNFalpha, improves health-related quality of life in patients with moderate — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In the population with CRP = 10 mg/L at baseline
Primary	Clinical response at week 6
Primary	Clinical response at week 6 and week 26
Secondary	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

External Links

•   Clinical Study Summary on UCB.com