Long-term Treatment Study of Certolizumab Pegol Without Coadministration of Methotrexate in Japanese Rheumatoid Arthritis (RA) Patients

NCT ID: NCT00850343

Last Updated: 2014-11-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 208 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2013-05-31

Brief Summary

The objectives of this study are to evaluate the safety and efficacy of certolizumab pegol when administered without coadministration of methotrexate over the long term in Japanese RA patients who transferred from Study 275-08-003 (NCT00791921), and to evaluate the effects of different dosing regimens on the safety and efficacy of certolizumab pegol in American College of Rheumatology 20% (ACR20) responders who completed Study 275-08-003.

Detailed Description

This study was initiated by Otsuka Pharmaceutical Co., Ltd and transferred to Astellas on 12/04/2012.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Certolizumab pegol 200 mg

Participants received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.

Group Type: EXPERIMENTAL

Certolizumab pegol

Intervention Type: DRUG

Subcutaneous (SC) injection

Certolizumab pegol 400 mg

Participants received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.

Group Type: EXPERIMENTAL

Certolizumab pegol

Intervention Type: DRUG

Subcutaneous (SC) injection

Interventions

Certolizumab pegol

Subcutaneous (SC) injection

Intervention Type: DRUG

Other Intervention Names

Cimzia; CDP870

Eligibility Criteria

Inclusion Criteria

• Subjects who participated in Study 275-08-003 and meet all of the criteria described below.

• Patients who did not reach ACR20, and prematurely discontinued Study 275-08-003 at Week 16 or completed Study 275-08-003 by Week 24.

Exclusion Criteria

• Patients who experienced an important protocol deviation as mentioned below during Study 275-08-003.
• Patients who received live or attenuated vaccines during Study 275-08-003 (Except for influenza or pneumococcal vaccines).
• Patients who were found to have tuberculosis on a chest X-ray during Study 275-08-003.
• Patients who required treatment for the same infection at two or more different times during Study 275-08-003
• Women who are pregnant, are lactating, of childbearing potential and wish to conceive during the study and post-study 3 months.
• Patients whom the investigator has decided to be inappropriate for participation in the study

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UCB Japan Co. Ltd.

INDUSTRY

Sponsor Role: collaborator

Astellas Pharma Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chubu Region, , Japan

Chugoku Region, , Japan

Hokkaido Region, , Japan

Kanto Region, , Japan

Kinki Region, , Japan

Kyushu Region, , Japan

Shikoku Region, , Japan

Tohoku Region, , Japan

Countries

Japan

Other Identifiers

JapicCTI-090701

Identifier Type: -

Identifier Source: secondary_id

CDP870-275-08-004

Identifier Type: -

Identifier Source: org_study_id