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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
To increase the ADA dose from 40 mg eow to 80 mg eow
Saitama Medical Center
Kawagoe, Saitama, Japan
NOT_YET_RECRUITINGKeio University Hospital
Shinanomachi, Tokyo, Japan
RECRUITINGThe rate of achieving remission at week 30
Time frame: 30 weeks
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