Clinical Study of CDP870/Certolizumab Pegol in Patients With Active Crohn's Disease

• Conditions: Crohn’s Disease; MedDRA version: 17.1Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2014-004399-42-Outside-EU/EEA
• Lead Sponsor: CB Japan Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-05
• Last Update Posted: 9 March 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

- Patients who are diagnosed with Crohn's disease (according to the Crohn’s disease diagnostic criteria developed by the research group on intractable inflammatory bowel disorders [Shimoyama group, January 25, 2002]) at least 24 weeks before the starting date of the observation period
- Patients with Crohn’s Disease Activity Index (CDAI) score ranging from 220 to 450 inclusive during the observation period
- C-reactive protein (CRP) of 1 mg/dL or higher in the laboratory test performed at the start of the observation period

Are the trial subjects under 18? yes
Number of subjects for this age range: 30
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

- Stoma patient
- Patients with a history of severe hypersensitivity or anphylactic reaction to anti-TNF alpha antibody
- Patients who participated in a clinical study with CDP870
- Pregnant or lactating patients, patients of childbearing potential, or patients who will attempt pregnancy during the study period
- Patients who are judged inappropriate for enrollment by the principal investigator or subinvestigators

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: Week 6;Main Objective: The primary objective of the study was to estimate the dose response in subjects with active Crohn’s Disease (CD), and to evaluate the efficacy of certolizumab pegol in these subjects. <br>;Secondary Objective: Secondary objectives were to evaluate the safety and tolerability of certolizumab pegol in subjects with active CD and to obtain data on the plasma certolizumab pegol concentrations and anti-certolizumab pegol antibody levels up to Week 16 following dosing at Weeks 0, 2, and 4 (induction period). <br>;Primary end point(s): Crohn’s Disease Activity Index (CDAI) response (clinical response or remission) at Week 6 <br>