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A Study of Tocilizumab [RoActemra/Actemra] Versus Adalimumab in Patients With Rheumatoid Arthritis

2014-08-27 03:13:52 | BioPortfolio

Summary

This randomized, blinded, parallel arm study will evaluate the efficacy and safety of tocilizumab [RoActemra/Actemra] versus adalimumab as monotherapy in patients with rheumatoid arthritis who are intolerant of methotrexate or where continued treatment with methotrexate is considered inappropriate. Patients will be randomized to receive either tocilizumab (8mg/kg intravenously) every 4 weeks plus placebo sc every 2 weeks, or adalimumab (40mg subcutaneously) every 2 weeks plus placebo iv every 4 weeks. Anticipated time on study treatment is 24 weeks. With regard to the blind, the study nurse will be unblinded due to the nature of the treatment administration, but the investigator and the patient will remain blinded. Target sample size is 200-400 patients.

Study Design

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

Conditions

Rheumatoid Arthritis

Intervention

tocilizumab [RoActemra/Actemra], adalimumab, placebo, placebo

Location

Aniston
Alabama
United States
36207

Status

Recruiting

Source

Hoffmann-La Roche

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:52-0400

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PubMed Articles [2179 Associated PubMed Articles listed on BioPortfolio]

Changes in Serum Interleukin-6 Levels as Possible Predictor of Efficacy of Tocilizumab Treatment in Rheumatoid Arthritis.

We aimed to evaluate the association between the change in serum IL-6 during the clinical course of tocilizumab (TCZ) therapy and rheumatoid arthritis (RA) disease activity or occurrence of adverse ev...

B-cell phenotype and IgD-CD27- memory B cells are affected by TNF-inhibitors and tocilizumab treatment in rheumatoid arthritis.

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Comparison of the risks of hospitalisation for cardiovascular events in patients with rheumatoid arthritis treated with tocilizumab and etanercept.

To verify if tocilizumab (TCZ) is associated with an increased risk of cardiovascular (CV) events compared with etanercept (ETN) in rheumatoid arthritis (RA).

Switching From Reference Adalimumab to SB5 (Adalimumab Biosimilar) in Patients With Rheumatoid Arthritis: 52-Week Phase 3 Randomized Study Results.

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Medical and Biotech [MESH] Definitions

A humanized monoclonal antibody that binds specifically to TNF-ALPHA and blocks its interaction with endogenous TNF RECEPTORS to modulate INFLAMMATION. It is used in the treatment of RHEUMATOID ARTHRITIS; PSORIATIC ARTHRITIS; CROHN'S DISEASE and ULCERATIVE COLITIS.

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.

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

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.

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