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Completed

NCT Number: NCT01026519

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

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Institute of Rheumatology under the Russian Academy of Medical Sciences

Moscow, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

REGN88

Drug

Single dose of REGN88 and 43 day follow up.

Placebo

Other

Placebo to match REGN88 administration

Primary outcomes

  1. hs-C reactive protein (hs-CRP)

    Time frame: 43 Days

Secondary outcomes

  1. Subject's Assessment of Pain and Subject's Global Assessment of Disease activity

    Time frame: 43 Days

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Collaborators

  • Sanofi

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Dec 4, 2009
Registry last updated
Sep 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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