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

Rheumatoid Arthritis Clinical Trial

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01270035
Study type Interventional
Source Keio University
Contact Hideto Kameda, MD. PhD
Phone +81-3-5843-6179
Email kamehide@z6.keio.jp
Status Recruiting
Phase Phase 4
Start date January 2011
View Details
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