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

Astellas

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: Methotrexate; Drug: Certolizumab pegol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00851318

JapicCTI-090700

CDP870-275-08-002

Details and patient eligibility

About

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.

Full description

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

Enrollment: 285 patients

Sex: All

Ages: 20 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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285 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 in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.

Treatment:

Drug: Certolizumab pegol

Drug: Methotrexate

Certolizumab pegol 400 mg

Experimental group

Description:

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.

Treatment:

Drug: Certolizumab pegol

Drug: Methotrexate