Long-term Treatment Study of Certolizumab Pegol (CDP870) as Add-on Medication to Methotrexate in Japanese Rheumatoid Arthritis (RA) Patients

NCT ID: NCT00851318

Last Updated: 2014-11-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 285 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2013-06-30

Brief Summary

The objectives of this study are to evaluate the safety and efficacy of certolizumab pegol as add-on medication to methotrexate over the long term in Japanese RA patients transferred from Study 275-08-001 (NCT00791999), 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 275-08-001.

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 in combination with methotrexate 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

Methotrexate

Intervention Type: DRUG

Methotrexate dose between 6 to 8 mg/week.

Certolizumab pegol 400 mg

Participants received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate 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

Methotrexate

Intervention Type: DRUG

Methotrexate dose between 6 to 8 mg/week.

Interventions

Certolizumab pegol

Subcutaneous (SC) injection

Intervention Type: DRUG

Methotrexate

Methotrexate dose between 6 to 8 mg/week.

Intervention Type: DRUG

Other Intervention Names

CDP870; Cimzia

Eligibility Criteria

Inclusion Criteria

• Subjects who participated in Study 275-08-001 and meet all of the criteria described below.

• Patients who did not reach ACR20, and prematurely discontinued Study 275-08-001 at Week 16 or completed Study 275-08-001 by Week 24.
• Patients who are able to receive treatment with MTX, by Week 52.

Exclusion Criteria

• Patients who experienced an important protocol deviation as mentioned below during Study 275-08-001.
• Patients who received live or attenuated vaccines during Study 275-08-001(Except for influenza or pneumococcal vaccines).
• Patients who were found to have tuberculosis on a chest X-ray during Study 275-08-001.
• Patients who required treatment for the same infection at two or more different times during Study 275-08-001
• 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-090700

Identifier Type: -

Identifier Source: secondary_id

CDP870-275-08-002

Identifier Type: -

Identifier Source: org_study_id