A Multiple-dose Study of the Safety and Tolerability of REGN88(SAR153191) in Rheumatoid Arthritis Subjects
NCT ID: NCT01011959
Last Updated: 2013-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
60 participants
INTERVENTIONAL
2008-12-31
2009-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
dose 1 vs. placebo
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.
2
dose 2 vs. placebo
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.
3
dose 3 vs. placebo
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.
4
dose 4 vs. placebo
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.
5
dose 5 vs. placebo
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.
6
dose 6 vs. placebo
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients currently treated with concomitant methotrexate for at least 12 weeks, with a stable dose for at least 6 weeks
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sanofi
INDUSTRY
Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Allen Radin, MD
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Santa Maria, California, United States
Boca Raton, Florida, United States
Clearwater, Florida, United States
Daytona Beach, Florida, United States
Delray Beach, Florida, United States
Palm Harbor, Florida, United States
Idaho Falls, Idaho, United States
Worcester, Massachusetts, United States
Lansing, Michigan, United States
Flowood, Mississippi, United States
Kalamzaoo, Missouri, United States
St Louis, Missouri, United States
Reno, Nevada, United States
Charlotte, North Carolina, United States
Cincinnati, Ohio, United States
Toledo, Ohio, United States
Oklahoma City, Oklahoma, United States
Duncansville, Pennsylvania, United States
Greenville, South Carolina, United States
Orangeburg, South Carolina, United States
Hixson, Tennessee, United States
Austin, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
6R88-RA-0802
Identifier Type: -
Identifier Source: org_study_id