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

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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)

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

Trial contacts and locations

8

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Data sourced from clinicaltrials.gov

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