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A Safety and Tolerability Study of REGN88(SAR153191) in Subjects With Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT01026519
Recruitment Status : Completed
First Posted : December 4, 2009
Last Update Posted : September 30, 2013
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: REGN88 Other: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : September 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Dose 1
Active dose
Drug: REGN88
Single dose of REGN88 and 43 day follow up.
Experimental: Dose 2
Active dose
Drug: REGN88
Single dose of REGN88 and 43 day follow up.
Experimental: Dose 3
Active 3
Drug: REGN88
Single dose of REGN88 and 43 day follow up.
Placebo Comparator: Dose 4
Placebo dose
Other: Placebo
Placebo to match REGN88 administration



Primary Outcome Measures :
  1. hs-C reactive protein (hs-CRP) [ Time Frame: 43 Days ]

Secondary Outcome Measures :
  1. Subject's Assessment of Pain and Subject's Global Assessment of Disease activity [ Time Frame: 43 Days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female ≥18 years of age
  2. Subjects must weigh >50 and <100 kg
  3. 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:

  1. A history of Listeriosis or active tuberculosis (TB)
  2. Persistent chronic or active recurring infection requiring treatment with antibiotics, antivirals, or antifungals within 4 weeks prior to the Screening Visit
  3. History of prior articular or prosthetic joint infection
  4. History of a hypersensitivity reaction, other than localized injection site reaction (ISR), to any biological molecule
  5. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01026519


Locations
Russian Federation
Institute of Rheumatology under the Russian Academy of Medical Sciences
Moscow, Russian Federation
Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
Study Director: Allen Radin, MD Regeneron Pharmaceuticals

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01026519     History of Changes
Other Study ID Numbers: 6R88-RA-0803
First Posted: December 4, 2009    Key Record Dates
Last Update Posted: September 30, 2013
Last Verified: June 2011

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases