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

Phase 1

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: REGN88; Other: Placebo

• Registration Number: NCT01026519
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Primary Completion: 2009-03
• Study Completion: 2009-05
• Study First Submitted: 2009-12-02
• Study First Submitted QC: 2009-12-02
• Study First Posted: 2009-12-04
• Status Verified: 2011-06
• Last Update Submitted: 2013-09-27
• Last Update Posted: 2013-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose 3	REGN88	Active 3
Dose 4	Placebo	Placebo dose
Dose 1	REGN88	Active dose
Dose 2	REGN88	Active dose

Primary Outcome Measures

Name	Time	Method
hs-C reactive protein (hs-CRP)	43 Days

Secondary Outcome Measures

Name	Time	Method
Subject's Assessment of Pain and Subject's Global Assessment of Disease activity	43 Days

Trial Locations

Locations (1)

Institute of Rheumatology under the Russian Academy of Medical Sciences; 🇷🇺 Moscow, Russian Federation