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

Sponsor
Keio University
Study ID
NCT01270035
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Adalimumab — DRUG
    To increase the ADA dose from 40 mg eow to 80 mg eow

Study Details

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.

Key Dates

Start date
Jan 31, 2011
Status verified
Dec 2010
Primary completion
Jan 31, 2014

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ADA 80 mg eow + MTX

Primary Outcome Measure

The rate of achieving remission at week 30 [ Time Frame: 30 weeks ]

Central Contacts

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