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

Astellas

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: Certolizumab pegol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00850343

CDP870-275-08-004

JapicCTI-090701

Details and patient eligibility

About

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.

Full description

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

Enrollment: 208 patients

Sex: All

Ages: 20 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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208 participants in 2 patient groups

Certolizumab pegol 200 mg

Experimental group

Description:

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.

Treatment:

Drug: Certolizumab pegol

Certolizumab pegol 400 mg

Experimental group

Description:

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.

Treatment:

Drug: Certolizumab pegol