A Multiple-dose Study of the Safety and Tolerability of REGN88(SAR153191) in Rheumatoid Arthritis Subjects

Completed · Phase 1

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT01011959

Run by

Regeneron Pharmaceuticals

People needed

60

Starts

2008-12-01

Expected to finish

2009-08-01

Last updated by the study team

2013-09-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with an established diagnosis of Rheumatoid Arthritis
• Patients currently treated with concomitant methotrexate for at least 12 weeks, with a stable dose for at least 6 weeks

You may not qualify if…

• Persistent chronic or current active infections
• Patients who have taken anakinra within 2 weeks
• Patients who have taken etanercept, cyclosporine, mycophenolate, tacrolimus, gold, penicillamine, sulfasalazine or hydroxychloroquine within 4 weeks
• Patients who have taken adalimumab within 6 weeks
• Patients who have taken abatacept, azathioprine, cyclophosphamide or infliximab within 12 weeks
• Patients who have taken leflunomide or rituximab within 6 months
• Patients who have had prior treatment with tocilizumab or any other anti-IL-6 medication
• Significant arthritis or other medical condition that could interfere with study evaluations
• Participation in any clinical research study evaluating another investigational drug within 30 days

Where it is running

• Study site — Santa Maria, California, United States
• Study site — Boca Raton, Florida, United States
• Study site — Clearwater, Florida, United States
• Study site — Daytona Beach, Florida, United States
• Study site — Delray Beach, Florida, United States
• Study site — Palm Harbor, Florida, United States
• Study site — Idaho Falls, Idaho, United States
• Study site — Worcester, Massachusetts, United States
• Study site — Lansing, Michigan, United States
• Study site — Flowood, Mississippi, United States
• Study site — Kalamzaoo, Missouri, United States
• Study site — St Louis, Missouri, United States
• Study site — Reno, Nevada, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Toledo, Ohio, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Duncansville, Pennsylvania, United States
• Study site — Greenville, South Carolina, United States
• Study site — Orangeburg, South Carolina, United States
• Study site — Hixson, Tennessee, United States
• Study site — Austin, Texas, United States
• Study site — Houston, Texas, United States
• Study site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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