A Phase 1 interventional study of REGN88 and REGN88 in Rheumatoid Arthritis, sponsored by Regeneron Pharmaceuticals. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-09-30.
Sponsored by Regeneron Pharmaceuticals · Phase 1, Interventional, and Treatment
This study will test the safety and tolerability (how the body reacts to the drug) of REGN88 and placebo (an inactive substance that contains no medicine) in patients with Rheumatoid Arthritis.
This is a multi-center, randomized, double blind, placebo-controlled, single dose escalation study of the safety and tolerability of subcutaneously administered REGN88 in rheumatoid arthritis patients who are receiving concomitant methotrexate.
Three (3) sequential dose cohorts of 5 subjects (4:1 active: placebo) will be dosed SC with REGN88 or placebo. Subjects who complete the study will participate in 14 study visits over 16 weeks.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 15 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →Regeneron Pharmaceuticals is the lead sponsor of 400 studies on the registry; 91 are open to participants now.
Of its 120 completed or terminated interventional studies of FDA-regulated products, 77 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
First dose of SC REGN88
Biological: REGN88
Second dose of SC REGN88
Biological: REGN88
Third dose of SC REGN88
Biological: REGN88
Single SC Dose
Single SC Dose
Single SC Dose
To assess the safety and tolerability of a single dose of subcutaneously administered REGN88 in subjects with rheumatoid arthritis who are receiving concomitant treatment with methotrexate
Time frame: 113 Days
To assess the PK profile of a single subcutaneous (SC) dose of REGN88, and the immunogenicity of a single SC dose of REGN88
Time frame: 113 days
This study is completed, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.
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Regeneron Pharmaceuticals