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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01026519
First Posted: December 4, 2009
Last Update Posted: September 30, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
December 2, 2009
December 4, 2009
September 30, 2013
September 2008
March 2009   (Final data collection date for primary outcome measure)
hs-C reactive protein (hs-CRP) [ Time Frame: 43 Days ]
Same as current
Complete list of historical versions of study NCT01026519 on ClinicalTrials.gov Archive Site
Subject's Assessment of Pain and Subject's Global Assessment of Disease activity [ Time Frame: 43 Days ]
Same as current
Not Provided
Not Provided
 
A Safety and Tolerability Study of REGN88(SAR153191) in Subjects With Rheumatoid Arthritis
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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Drug: REGN88
    Single dose of REGN88 and 43 day follow up.
  • Other: Placebo
    Placebo to match REGN88 administration
  • Experimental: Dose 1
    Active dose
    Intervention: Drug: REGN88
  • Experimental: Dose 2
    Active dose
    Intervention: Drug: REGN88
  • Experimental: Dose 3
    Active 3
    Intervention: Drug: REGN88
  • Placebo Comparator: Dose 4
    Placebo dose
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
May 2009
March 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Russian Federation
 
 
NCT01026519
6R88-RA-0803
Not Provided
Not Provided
Not Provided
Regeneron Pharmaceuticals
Regeneron Pharmaceuticals
Sanofi
Study Director: Allen Radin, MD Regeneron Pharmaceuticals
Regeneron Pharmaceuticals
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP