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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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A Study of Subcutaneous RoActemra/Actemra (Tocilizumab) in Patients With Active Rheumatoid Arthritis and Inadequate Response to Disease-Modifying Antirheumatic Drugs

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PubMed Articles [1993 Associated PubMed Articles listed on BioPortfolio]

Tocilizumab and the risk for cardiovascular disease: a direct comparison among biologic disease-modifying antirheumatic drugs for rheumatoid arthritis patients.

Multiple studies have observed seemingly unfavorable changes in lipid profiles associated with IL6 receptor antagonists (IL-6R) and some other rheumatoid arthritis (RA) therapies. The real-world cardi...

Remodeling of the HDL proteome with treatment response to abatacept or adalimumab in the AMPLE trial of patients with rheumatoid arthritis.

To evaluate changes in the high-density lipoprotein (HDL) proteome and HDL function in active rheumatoid arthritis (RA) patients initiating therapy with abatacept or adalimumab in the Abatacept Versus...

Heart Rate-corrected QT Interval Duration in Rheumatoid Arthritis and Its Reduction with Treatment with the Interleukin 6 Inhibitor Tocilizumab.

Individuals with rheumatoid arthritis (RA) are at a heightened risk of sudden cardiac death, an outcome increased in those with prolongation of the corrected electrocardiographic QT interval (QTc). We...

Usefulness of tocilizumab for treating rheumatoid arthritis with myelodysplastic syndrome: A case report and literature review.

Dysregulated immune function in rheumatoid arthritis (RA) might lead to the development of myelodysplastic syndrome (MDS). Serum interleukin-6 (IL-6) concentrations are increased in both RA and MDS pa...

Real-world Comparative Effectiveness of Tocilizumab Monotherapy vs. Tumor Necrosis Factor Inhibitors with Methotrexate in Patients with Rheumatoid Arthritis.

Controlled clinical studies have shown that the efficacy of tocilizumab (TCZ) monotherapy is superior to that of tumor necrosis factor inhibitor (TNFi) monotherapy and comparable to that of TCZ plus m...

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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