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

02:57 EDT 19th April 2014 | 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

Medical and Biotech [MESH] Definitions

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.

A butyl-diphenyl-pyrazolidinedione that has anti-inflammatory, antipyretic, and analgesic activities. It has been used in ANKYLOSING SPONDYLITIS; RHEUMATOID ARTHRITIS; and REACTIVE ARTHRITIS.

Clinical Trials [689 Associated Clinical Trials listed on BioPortfolio]

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 pa...

A Multiple-dose Study of the Safety and Tolerability of REGN88(SAR153191) in Rheumatoid Arthritis Subjects

This is a randomized study of the safety and tolerability of multiple doses of REGN88 in rheumatoid arthritis patients who are receiving treatment with methotrexate.

Long Term Evaluation of SAR153191 (REGN88) on Top of Disease Modifying Anti-rheumatic Drugs in Rheumatoid Arthritis Patients

Primary Objective: - To assess the long term safety of SAR153191 on top of Disease Modifying Anti-Rheumatic Drugs (DMARDs) in patients with rheumatoid arthritis Secondary O...

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Extension Study for Long Term Evaluation of SAR153191 (REGN88) in Patients With Ankylosing Spondylitis

Primary Objective: - To assess the long term safety of SAR153191 in patients with ankylosing spondylitis Secondary Objective: - To assess the long term efficacy of SAR153191...

PubMed Articles [1975 Associated PubMed Articles listed on BioPortfolio]

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