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

Regeneron Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Rheumatoid Arthritis

Treatments: Biological: REGN88

Study type: Interventional

Funder types: Industry

Identifiers

NCT01011959

6R88-RA-0802

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

60 participants in 6 patient groups

1

Active Comparator group

Description:

dose 1 vs. placebo

Treatment:

Biological: REGN88

2

Active Comparator group

Description:

dose 2 vs. placebo

Treatment:

Biological: REGN88

3

Active Comparator group

Description:

dose 3 vs. placebo

Treatment:

Biological: REGN88

4

Active Comparator group

Description:

dose 4 vs. placebo

Treatment:

Biological: REGN88

5

Active Comparator group

Description:

dose 5 vs. placebo

Treatment:

Biological: REGN88

6

Active Comparator group

Description:

dose 6 vs. placebo

Treatment:

Biological: REGN88