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

NCT ID: NCT01026519

Last Updated: 2013-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-05-31

Brief Summary

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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

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dose 1

Active dose

Group Type EXPERIMENTAL

REGN88

Intervention Type DRUG

Single dose of REGN88 and 43 day follow up.

Dose 2

Active dose

Group Type EXPERIMENTAL

REGN88

Intervention Type DRUG

Single dose of REGN88 and 43 day follow up.

Dose 3

Active 3

Group Type EXPERIMENTAL

REGN88

Intervention Type DRUG

Single dose of REGN88 and 43 day follow up.

Dose 4

Placebo dose

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo to match REGN88 administration

Interventions

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REGN88

Single dose of REGN88 and 43 day follow up.

Intervention Type DRUG

Placebo

Placebo to match REGN88 administration

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role collaborator

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Allen Radin, MD

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

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Institute of Rheumatology under the Russian Academy of Medical Sciences

Moscow, , Russia

Site Status

Countries

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Russia

Other Identifiers

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6R88-RA-0803

Identifier Type: -

Identifier Source: org_study_id