Clinical trial NCT00850343: Long-term Treatment Study of Certolizumab Pegol Without Coadministration of Methotrexate in Japanese Rheumatoid Arthritis (RA) Patients
Official title: A Multicenter, Open-label, Long-term Safety Study of CDP870 to Evaluate the Safety and Efficacy of CDP870 Administered Without Coadministration of Methotrexate (MTX) Over the Long Term in Patients With Active Rheumatoid Arthritis Transferred From the Efficacy Confirmatory Study (Study 275-08-003)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Certolizumab Pegol
Cimzia
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: UCB Japan Co. Ltd.
First posted: 2009-02-25
Enrollment: 208
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
Secondary outcomes:
measure: Percentage of Participants With American College of Rheumatology 20% (ACR20) Response
timeFrame: Baseline (of Study 275-08-003), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)
measure: Percentage of Participants With American College of Rheumatology 50% (ACR50) Response
timeFrame: Baseline (of Study 275-08-003), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)
measure: Percentage of Participants With American College of Rheumatology 70% (ACR70) Response
timeFrame: Baseline (of Study 275-08-003), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)
measure: Change From Baseline in Disease Activity Score (DAS) 28
timeFrame: Baseline (of Study 275-08-003), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)
measure: Change From Baseline in Modified Total Sharp Score (mTSS)
timeFrame: Baseline (of Study 275-08-003), Week 0 (of this study) and Week 100
Other outcomes:
Locations:
city: Chubu Region
country: Japan
city: Chugoku Region
country: Japan
city: Hokkaido Region
country: Japan
city: Kanto Region
country: Japan
city: Kinki Region
country: Japan
city: Kyushu Region
country: Japan
city: Shikoku Region
country: Japan
city: Tohoku Region
country: Japan
Study officials:
References: