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

Purpose

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.

Condition	Intervention	Phase
Rheumatoid Arthritis	Biological: REGN88	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis

U.S. FDA Resources

Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:

Incidence of treatment-emergent adverse events in patients treated with REGN88 and placebo [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To evaluate exploratory efficacy endpoints [ Time Frame: over 10 weeks ] [ Designated as safety issue: No ]

Enrollment:	60
Study Start Date:	December 2008
Study Completion Date:	August 2009
Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 dose 1 vs. placebo	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: 2 dose 2 vs. placebo	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: 3 dose 3 vs. placebo	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: 4 dose 4 vs. placebo	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: 5 dose 5 vs. placebo	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: 6 dose 6 vs. placebo	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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01011959

Show 24 Study Locations

Sponsors and Collaborators

Regeneron Pharmaceuticals

Sanofi

Investigators

Study Director:

Allen Radin, MD

Regeneron Pharmaceuticals

More Information

No publications provided

Responsible Party:	Allen Radin, MD, Regeneron Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT01011959 History of Changes
Other Study ID Numbers:	6R88-RA-0802
Study First Received:	November 10, 2009
Last Updated:	June 1, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases

Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013