DRIVE
Phase 2
Completed
- Conditions
- Rheumatoid Arthritis
- Registration Number
- JPRN-jRCT2080221226
- Lead Sponsor
- DAIICHISANKYO Co.,Ltd.
- Brief Summary
In a placebo-controlled study, AMG 162 60 mg was subcutaneously administered for 12 months in RA patients on MTX therapy. AMG 162 showed a significant inhibitory effect on progression of bone erosion compared with that of placebo, and the change in bone erosion score were the smallest in the Q2M group, followed by the Q3M and Q6M groups. In the safety assessment, AMG 162 60 mg was well tolerated in the Q6M, Q3M and Q2M regimens.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 346
Inclusion Criteria
Ambulatory outpatients who are diagnosed with rheumatoid arthritis according to the American College of Rheumatology (ACR) criteria for rheumatoid arthritis classification (1987 revision)
Exclusion Criteria
-Functional class IV according by the ACR revised classification (1991)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>efficacy<br>confirmatory<br>Erosion Score<br>modified Sharp
- Secondary Outcome Measures
Name Time Method efficacy<br>pharmacokinetics<br>1:Total Sharp Score,Joint Space Narrowing score<br>2:Bone Mineral Density<br>3:Pharmacokinetics (Serum AMG 162 concentration)<br><br>1:modified Sharp<br>2:DXA