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

Phase 1

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Biological: REGN88

• Registration Number: NCT01011959
• Lead Sponsor: Regeneron Pharmaceuticals

Brief 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.

Detailed Description

This is a multi-centered, randomized, double-blind, placebo-controlled, ascending parallel-group study of the safety and tolerability of REGN88 in patients with rheumatoid arthritis who are receiving concomitant methotrexate.

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 not begin until enrollment in Part B is complete.

Study Timeline

• Study Start: 2008-12
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Study First Submitted: 2009-11-10
• Study First Submitted QC: 2009-11-10
• Study First Posted: 2009-11-11
• Status Verified: 2011-06
• Last Update Submitted: 2013-09-27
• Last Update Posted: 2013-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 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

Read More

Exclusion Criteria

• 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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	REGN88	dose 1 vs. placebo
2	REGN88	dose 2 vs. placebo
3	REGN88	dose 3 vs. placebo
4	REGN88	dose 4 vs. placebo
5	REGN88	dose 5 vs. placebo
6	REGN88	dose 6 vs. placebo

Primary Outcome Measures

Name	Time	Method
Incidence of treatment-emergent adverse events in patients treated with REGN88 and placebo	10 weeks

Secondary Outcome Measures

Name	Time	Method
To evaluate exploratory efficacy endpoints	over 10 weeks