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

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01011959
First received: November 10, 2009
Last updated: September 27, 2013
Last verified: June 2011

November 10, 2009
September 27, 2013
December 2008
August 2009   (final data collection date for primary outcome measure)
Incidence of treatment-emergent adverse events in patients treated with REGN88 and placebo [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01011959 on ClinicalTrials.gov Archive Site
To evaluate exploratory efficacy endpoints [ Time Frame: over 10 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Multiple-dose Study of the Safety and Tolerability of REGN88(SAR153191) in Rheumatoid Arthritis Subjects
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

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Rheumatoid Arthritis
Biological: REGN88
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.
  • Active Comparator: 1
    dose 1 vs. placebo
    Intervention: Biological: REGN88
  • Active Comparator: 2
    dose 2 vs. placebo
    Intervention: Biological: REGN88
  • Active Comparator: 3
    dose 3 vs. placebo
    Intervention: Biological: REGN88
  • Active Comparator: 4
    dose 4 vs. placebo
    Intervention: Biological: REGN88
  • Active Comparator: 5
    dose 5 vs. placebo
    Intervention: Biological: REGN88
  • Active Comparator: 6
    dose 6 vs. placebo
    Intervention: Biological: REGN88
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
August 2009
August 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01011959
6R88-RA-0802
No
Regeneron Pharmaceuticals
Regeneron Pharmaceuticals
Sanofi
Study Director: Allen Radin, MD Regeneron Pharmaceuticals
Regeneron Pharmaceuticals
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP