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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Ascending Parallel-group Study of the Safety and Tolerability of REGN88 in Subjects With Rheumatoid Arthritis Receiving Concomitant Methotrexate

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Biological: REGN88


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>dose 1 vs. placebo | Biological: REGN88<br>* 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.<br>|
| Active Comparator: 2<br>dose 2 vs. placebo | Biological: REGN88<br>* 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.<br>|
| Active Comparator: 3<br>dose 3 vs. placebo | Biological: REGN88<br>* 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.<br>|
| Active Comparator: 4<br>dose 4 vs. placebo | Biological: REGN88<br>* 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.<br>|
| Active Comparator: 5<br>dose 5 vs. placebo | Biological: REGN88<br>* 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.<br>|
| Active Comparator: 6<br>dose 6 vs. placebo | Biological: REGN88<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment-emergent adverse events in patients treated with REGN88 and placebo |  | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate exploratory efficacy endpoints |  | over 10 weeks |