Evaluation of SAR153191(REGN88) on Top of Methotrexate in Rheumatoid Arthritis Patients
- 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)
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.
The maximum study duration for a patient is 22 weeks for Part A and 62 weeks for Part B.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Sanofi-Aventis Investigational Site Number 840007
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT01061736
- Information obtained from ClinicalTrials.gov on July 15, 2010
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...
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.
Primary objective of the study: - to evaluate the efficacy by (ASAS20) (Assessment in Ankylosing Spondylitis Working Group responses criteria) of SAR153191 in patients with AS (Ankylosing...
Primary Objective: Assess the long term safety of sarilumab in patients with rheumatoid arthritis. Secondary Objective: Assess the long term efficacy of sarilumab in patients with...
Primary Objective: To evaluate the effect of a single 200 mg subcutaneous injection of sarilumab on the pharmacokinetics of simvastatin in patients with rheumatoid arthritis Second...
Rheumatoid arthritis patients are susceptible to interstitial lung disease, and joint manifestations of rheumatoid arthritis usually precede lung involvements by several years. Organizing pneumonia, a...
Oral gold (auranofin) has been used in 31 patients, 20 with active rheumatoid arthritis and 11 with active psoriatic arthritis. In rheumatoid arthritis the oral gold treatment was compared to parenter...
The co-occurrence of rheumatoid factor (RF) and anti-citrullinated protein antibody (ACPA) positivity in rheumatoid arthritis (RA) is well described. However, the mechanisms underlying the potential i...
Objective: To evaluate ixekizumab, an anti-IL-17A monoclonal antibody, in 2 rheumatoid arthritis (RA) populations: biologic therapy-naïve or tumor necrosis factor inhibitor inadequate responders (TNF...
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 ...
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.