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

01:37 EDT 27th April 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

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PubMed Articles [2026 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.

Angiogenic gene expression and vascular density are reflected in ultrasonographic features of synovitis in early Rheumatoid Arthritis: an observational study.

Neovascularization contributes to the development of sustained synovial inflammation in the early stages of Rheumatoid Arthritis. Ultrasound (US) provides an indirect method of assessing synovial bloo...

Effects of phylloquinone supplementation on lipid profile in women with rheumatoid arthritis: a double blind placebo controlled study.

Rheumatoid arthritis (RA) is associated with an excess mortality from cardiovascular disease which is likely attributed to an atherogenic lipid profile. Among nutritional factors vitamin K has been re...

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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