Safety Study of a Single Dose of REGN88(SAR153191)in Patients With Rheumatoid Arthritis

Phase 1

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Biological: REGN88

• Registration Number: NCT01055899
• Lead Sponsor: Regeneron Pharmaceuticals

Brief Summary

This study will test the safety and tolerability (how the body reacts to the drug) of REGN88 and placebo (an inactive substance that contains no medicine) in patients with Rheumatoid Arthritis.

Detailed Description

This is a multi-center, randomized, double blind, placebo-controlled, single dose escalation study of the safety and tolerability of subcutaneously administered REGN88 in rheumatoid arthritis patients who are receiving concomitant methotrexate.

Three (3) sequential dose cohorts of 5 subjects (4:1 active: placebo) will be dosed SC with REGN88 or placebo. Subjects who complete the study will participate in 14 study visits over 16 weeks.

Study Timeline

• Study Start: 2008-07
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Study First Submitted: 2010-01-25
• Study First Submitted QC: 2010-01-25
• Study First Posted: 2010-01-26
• Status Verified: 2011-06
• Last Update Submitted: 2013-09-27
• Last Update Posted: 2013-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1. Male or female ≥ 18 years of age
2. Subjects must weigh > 50 kg 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
4. For women of childbearing potential, a negative serum pregnancy test at the Screening Visit (Visit 1) and a negative urine pregnancy test at Day -1
5. For men and women of childbearing potential, willingness to utilize adequate contraception and not become pregnant (or have their partner[s] become pregnant) during the full course of the study.

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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
6. Received administration of any live (attenuated) vaccine within 3 months prior to the Screening Visit

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dose 2	REGN88	Second dose of SC REGN88
Dose 1	REGN88	First dose of SC REGN88
Dose 3	REGN88	Third dose of SC REGN88

Primary Outcome Measures

Name	Time	Method
To assess the safety and tolerability of a single dose of subcutaneously administered REGN88 in subjects with rheumatoid arthritis who are receiving concomitant treatment with methotrexate	113 Days

Secondary Outcome Measures

Name	Time	Method
To assess the PK profile of a single subcutaneous (SC) dose of REGN88, and the immunogenicity of a single SC dose of REGN88	113 days