NCT01270035

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Keio University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Adalimumab	To increase the ADA dose from 40 mg eow to 80 mg eow

Timeline

• Start date: 2011-01-01
• Primary completion: 2014-01-01
• First posted: 2011-01-05
• Last updated: 2011-06-27

Locations

2 sites across 1 country: Japan