Overview

Efficacy and Safety of Adalimumab 80 mg Every Other Week With Methotrexate

Status:
Unknown status

Trial end date:
1969-12-31

Target enrollment:
0

Participant gender:
All

Summary

In Japan, as well as in other countries, the dose of adalimumab (ADA) is limited to 40 mg every other week when used in combination with methotrexate (MTX) for patients with rheumatoid arthritis (RA). However, ADA 80 mg with MTX may be required for some RA patients, especially for those with high disease activity. Therefore, we tried to increase the ADA dose to 80 mg every other week with concomitant MTX, only if the disease activity did not decrease below moderate activity defined by DAS28 < 3.2. The primary endpoint was the rate of patients who achieved disease remission (DAS28 < 2.6) at 30 weeks with this predifined treatment strategy.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Keio University

Collaborator:

Saitama Medical University

Treatments:

Adalimumab

Criteria

Inclusion Criteria:

- patients with rheumatoid arthritis receiving MTX ≧ 6 mg/week for at least 3 months
disease activity : DAS28 > 5.1

Exclusion Criteria:

- allergy to ADA present active infection including TB history of demyelinating disease,
HBV infection and malignancy