Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis Certolizumab Pegol Cimzia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 285
Healthy volunteers: no

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.

Arms:
arm 1: 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. arm 2: 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.

Interventions: intervention 1: Certolizumab pegol intervention 2: Methotrexate
Intervention descriptions: intervention 1: Subcutaneous (SC) injection intervention 2: Methotrexate dose between 6 to 8 mg/week.

Protocol document: