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Evaluation of SAR153191(REGN88) on Top of Methotrexate in Rheumatoid Arthritis Patients

2014-07-24 14:10:07 | BioPortfolio

Summary

Primary Objectives:

- To demonstrate that SAR153191 on top of Methotrexate (MTX) is effective on reduction of signs and symptoms of rheumatoid arthritis at 12 weeks (Part A)

- To demonstrate that SAR153191 on top of MTX is effective on reduction of signs and symptoms of rheumatoid arthritis at 24 weeks (Part B)

Secondary Objectives:

For Part B: to demonstrate that SAR153191 on top of MTX is effective on:

- inhibition of progression of structural damage at 52 weeks

- improvement in physical function at 52 weeks

- induction of a major clinical response at 52 weeks

To assess the safety of SAR153191 on top of MTX.

To document the pharmacokinetic profile of SAR153191 on top of MTX, in patients with active rheumatoid arthritis who are inadequate responders to MTX therapy.

Description

The maximum study duration for a patient is 22 weeks for Part A and 62 weeks for Part B.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Rheumatoid Arthritis

Intervention

SAR153191(REGN88), placebo

Location

Sanofi-Aventis Investigational Site Number 840007
Palm Desert
California
United States
92260

Status

Recruiting

Source

Sanofi-Aventis

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:10:07-0400

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Medical and Biotech [MESH] Definitions

Arthritis in children, with onset before 16 years of age. The terms juvenile rheumatoid arthritis (JRA) and juvenile idiopathic arthritis (JIA) refer to classification systems for chronic arthritis in children. Only one subtype of juvenile arthritis (polyarticular-onset, rheumatoid factor-positive) clinically resembles adult rheumatoid arthritis and is considered its childhood equivalent.

Rheumatoid arthritis of children occurring in three major subtypes defined by the symptoms present during the first six months following onset: systemic-onset (Still's Disease, Juvenile-Onset), polyarticular-onset, and pauciarticular-onset. Adult-onset cases of Still's disease (STILL'S DISEASE, ADULT-ONSET) are also known. Only one subtype of juvenile rheumatoid arthritis (polyarticular-onset, rheumatoid factor-positive) clinically resembles adult rheumatoid arthritis and is considered its childhood equivalent.

A variable mixture of the mono- and disodium salts of gold thiomalic acid used mainly for its anti-inflammatory action in the treatment of rheumatoid arthritis. It is most effective in active progressive rheumatoid arthritis and of little or no value in the presence of extensive deformities or in the treatment of other forms of arthritis.

Systemic-onset rheumatoid arthritis in adults. It differs from classical rheumatoid arthritis in that it is more often marked by acute febrile onset, and generalized lymphadenopathy and hepatosplenomegaly are more prominent.

Antibodies found in adult RHEUMATOID ARTHRITIS patients that are directed against GAMMA-CHAIN IMMUNOGLOBULINS.

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