A Multiple-dose Study of the Safety and Tolerability of REGN88(SAR153191) in Rheumatoid Arthritis Subjects
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
REGN88
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
1
2
3
4
5
6
Arm Description
dose 1 vs. placebo
dose 2 vs. placebo
dose 3 vs. placebo
dose 4 vs. placebo
dose 5 vs. placebo
dose 6 vs. placebo
Outcomes
Primary Outcome Measures
Incidence of treatment-emergent adverse events in patients treated with REGN88 and placebo
Secondary Outcome Measures
To evaluate exploratory efficacy endpoints
Full Information
NCT ID
NCT01011959
First Posted
November 10, 2009
Last Updated
September 27, 2013
Sponsor
Regeneron Pharmaceuticals
Collaborators
Sanofi
1. Study Identification
Unique Protocol Identification Number
NCT01011959
Brief Title
A Multiple-dose Study of the Safety and Tolerability of REGN88(SAR153191) in Rheumatoid Arthritis Subjects
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regeneron Pharmaceuticals
Collaborators
Sanofi
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
dose 1 vs. placebo
Arm Title
2
Arm Type
Active Comparator
Arm Description
dose 2 vs. placebo
Arm Title
3
Arm Type
Active Comparator
Arm Description
dose 3 vs. placebo
Arm Title
4
Arm Type
Active Comparator
Arm Description
dose 4 vs. placebo
Arm Title
5
Arm Type
Active Comparator
Arm Description
dose 5 vs. placebo
Arm Title
6
Arm Type
Active Comparator
Arm Description
dose 6 vs. placebo
Intervention Type
Biological
Intervention Name(s)
REGN88
Intervention Description
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 Outcome Measure Information:
Title
Incidence of treatment-emergent adverse events in patients treated with REGN88 and placebo
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
To evaluate exploratory efficacy endpoints
Time Frame
over 10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allen Radin, MD
Organizational Affiliation
Regeneron Pharmaceuticals
Official's Role
Study Director
Facility Information:
City
Santa Maria
State/Province
California
Country
United States
City
Boca Raton
State/Province
Florida
Country
United States
City
Clearwater
State/Province
Florida
Country
United States
City
Daytona Beach
State/Province
Florida
Country
United States
City
Delray Beach
State/Province
Florida
Country
United States
City
Palm Harbor
State/Province
Florida
Country
United States
City
Idaho Falls
State/Province
Idaho
Country
United States
City
Worcester
State/Province
Massachusetts
Country
United States
City
Lansing
State/Province
Michigan
Country
United States
City
Flowood
State/Province
Mississippi
Country
United States
City
Kalamzaoo
State/Province
Missouri
Country
United States
City
St. Louis
State/Province
Missouri
Country
United States
City
Reno
State/Province
Nevada
Country
United States
City
Charlotte
State/Province
North Carolina
Country
United States
City
Cincinnati
State/Province
Ohio
Country
United States
City
Toledo
State/Province
Ohio
Country
United States
City
Oklahoma City
State/Province
Oklahoma
Country
United States
City
Duncansville
State/Province
Pennsylvania
Country
United States
City
Greenville
State/Province
South Carolina
Country
United States
City
Orangeburg
State/Province
South Carolina
Country
United States
City
Hixson
State/Province
Tennessee
Country
United States
City
Austin
State/Province
Texas
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Multiple-dose Study of the Safety and Tolerability of REGN88(SAR153191) in Rheumatoid Arthritis Subjects
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