A Multiple-dose Study of the Safety and Tolerability of REGN88(SAR153191) in Rheumatoid Arthritis Subjects
NCT01011959 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2013-09-30
Summary
This is a randomized study of the safety and tolerability of multiple doses of REGN88 in rheumatoid arthritis patients who are receiving treatment with methotrexate.
Conditions
Interventions
- BIOLOGICAL
-
REGN88
This study will be conducted in 3 parts, and will include a total of 6 dose cohorts. Part B will not begin until the safety of Part A has been assessed. Part C will begin when enrollment into Part B is complete.
Sponsors & Collaborators
- collaborator INDUSTRY
- lead INDUSTRY
Principal Investigators
-
Allen Radin, MD · Regeneron Pharmaceuticals
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-12-31
- Primary Completion
- 2009-08-31
- Completion
- 2009-08-31
Countries
- United States
Study Locations
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