A Safety and Tolerability Study of REGN88(SAR153191) in Subjects With Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 1
Locations
Russian Federation
Study Type
Interventional
Intervention
REGN88
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria:
- Male or female ≥18 years of age
- Subjects must weigh >50 and <100 kg
- Diagnosis of Rheumatoid Arthritis (RA) as defined by the 1987 revised American College of Rheumatology (ACR) criteria with disease duration of no less than 6 months and ACR class I-III
Exclusion Criteria:
- A history of Listeriosis or active tuberculosis (TB)
- Persistent chronic or active recurring infection requiring treatment with antibiotics, antivirals, or antifungals within 4 weeks prior to the Screening Visit
- History of prior articular or prosthetic joint infection
- History of a hypersensitivity reaction, other than localized injection site reaction (ISR), to any biological molecule
- Significant concomitant illness such as, but not limited to cardiac, renal, neurological, endocrinological, metabolic or lymphatic disease that would adversely affect the subject's participation in this study
Sites / Locations
- Institute of Rheumatology under the Russian Academy of Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Dose 1
Dose 2
Dose 3
Dose 4
Arm Description
Active dose
Active dose
Active 3
Placebo dose
Outcomes
Primary Outcome Measures
hs-C reactive protein (hs-CRP)
Secondary Outcome Measures
Subject's Assessment of Pain and Subject's Global Assessment of Disease activity
Full Information
NCT ID
NCT01026519
First Posted
December 2, 2009
Last Updated
September 27, 2013
Sponsor
Regeneron Pharmaceuticals
Collaborators
Sanofi
1. Study Identification
Unique Protocol Identification Number
NCT01026519
Brief Title
A Safety and Tolerability Study of REGN88(SAR153191) in Subjects With Rheumatoid Arthritis
Official Title
A Single-dose, Double-Blind, Placebo-Controlled, Parallel Group Safety, Tolerability and Pharmacodynamic Study of Subcutaneous 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
September 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regeneron Pharmaceuticals
Collaborators
Sanofi
4. Oversight
5. Study Description
Brief Summary
This is a single-dose, double-blind, placebo-controlled, parallel group safety, tolerability and pharmacodynamic study of subcutaneously (SC) administered REGN88 in rheumatoid arthritis patients who are receiving concomitant methotrexate. Four (4) parallel groups of 8 subjects each with active rheumatoid arthritis will be dosed SC.
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dose 1
Arm Type
Experimental
Arm Description
Active dose
Arm Title
Dose 2
Arm Type
Experimental
Arm Description
Active dose
Arm Title
Dose 3
Arm Type
Experimental
Arm Description
Active 3
Arm Title
Dose 4
Arm Type
Placebo Comparator
Arm Description
Placebo dose
Intervention Type
Drug
Intervention Name(s)
REGN88
Intervention Description
Single dose of REGN88 and 43 day follow up.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo to match REGN88 administration
Primary Outcome Measure Information:
Title
hs-C reactive protein (hs-CRP)
Time Frame
43 Days
Secondary Outcome Measure Information:
Title
Subject's Assessment of Pain and Subject's Global Assessment of Disease activity
Time Frame
43 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female ≥18 years of age
Subjects must weigh >50 and <100 kg
Diagnosis of Rheumatoid Arthritis (RA) as defined by the 1987 revised American College of Rheumatology (ACR) criteria with disease duration of no less than 6 months and ACR class I-III
Exclusion Criteria:
A history of Listeriosis or active tuberculosis (TB)
Persistent chronic or active recurring infection requiring treatment with antibiotics, antivirals, or antifungals within 4 weeks prior to the Screening Visit
History of prior articular or prosthetic joint infection
History of a hypersensitivity reaction, other than localized injection site reaction (ISR), to any biological molecule
Significant concomitant illness such as, but not limited to cardiac, renal, neurological, endocrinological, metabolic or lymphatic disease that would adversely affect the subject's participation in this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allen Radin, MD
Organizational Affiliation
Regeneron Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Institute of Rheumatology under the Russian Academy of Medical Sciences
City
Moscow
Country
Russian Federation
12. IPD Sharing Statement
Learn more about this trial
A Safety and Tolerability Study of REGN88(SAR153191) in Subjects With Rheumatoid Arthritis
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