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

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01026519
First received: December 2, 2009
Last updated: September 27, 2013
Last verified: June 2011
  Purpose

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 Intervention Phase
Rheumatoid Arthritis
Drug: REGN88
Other: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • hs-C reactive protein (hs-CRP) [ Time Frame: 43 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subject's Assessment of Pain and Subject's Global Assessment of Disease activity [ Time Frame: 43 Days ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: September 2008
Study Completion Date: May 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01026519     History of Changes
Other Study ID Numbers: 6R88-RA-0803
Study First Received: December 2, 2009
Last Updated: September 27, 2013
Health Authority: Russia: Ethics Committee

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 August 28, 2014