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

09:42 EDT 29th March 2015 | 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

Clinical Trials [788 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.

Dose Ranging Study to Evaluate the Efficacy and Safety of SAR153191 (REGN88) in Patients With Ankylosing Spondylitis

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A Study Assessing the Efficacy and Safety of Sarilumab Added to MTX in Japanese Patients With Moderately to Severely Active Rheumatoid Arthritis (SARIL-RA-KAKEHASI)

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PubMed Articles [2064 Associated PubMed Articles listed on BioPortfolio]

NONSPECIFIC ULCERATIVE COLITIS IN COMBINATION WITH RHEUMATOID ARTHRITIS (CASE REPORT).

The rheumatoid arthritis in the structure of rheumatological diseases occupies about 10% and is one of the most widespread inflammatory diseases of joints. The joint damage often meeting by the nonspe...

Application of a prediction model for the progression of rheumatoid arthritis in patients with undifferentiated arthritis.

Different prediction rules have been applied to patients with undifferentiated arthritis (UA) to identify those that progress to rheumatoid arthritis (RA). The Leiden Prediction Rule (LPR) has proven ...

Contribution of dynamic radiographs in atlantoaxial subluxation in rheumatoid arthritis.

Cervical spine (CS) involvement is common during rheumatoid arthritis (RA) and it is distinguished by its potential gravity.

Increased risk of depression in patients with rheumatoid arthritis: a seven-year population-based cohort study.

Rheumatoid arthritis (RA) is a costly and crippling autoimmune disease that can lead to the development of depression, contributing to suboptimal clinical outcomes. However, no longitudinal studies ha...

Targeting cell migration in rheumatoid arthritis.

To provide an update of past failures, future prospects and key challenges facing the therapeutic targeting of chemokines and their receptors in rheumatoid arthritis.

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.

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