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NCT Number: NCT01011959

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

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Santa Maria, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

REGN88

Biological

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.

Primary outcomes

  1. Incidence of treatment-emergent adverse events in patients treated with REGN88 and placebo

    Time frame: 10 weeks

Secondary outcomes

  1. To evaluate exploratory efficacy endpoints

    Time frame: over 10 weeks

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Collaborators

  • Sanofi

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Nov 11, 2009
Registry last updated
Sep 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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