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This study will assess the onset and maintenance of effect of tocilizumab on relief in patients with active moderate or severe rheumatoid arthritis who have had an inadequate response to DMARDs or anti-TNF. For the first, double-blind, part of the study patients will be randomized to receive an iv infusion of either 8mg/kg tocilizumab or placebo. After 4 weeks this will be followed by 11 months treatment with tocilizumab 8mg/kg iv infusion every 4 weeks. Methotrexate or DMARD therapy will be continued throughout study treatment. Target sample size is >100.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
tocilizumab [RoActemra/Actemra], placebo, tocilizumab [RoActemra/Actemra]
Published on BioPortfolio: 2014-07-23T21:13:20-0400
This open-label, single-arm study will evaluate the efficacy and safety of subcu taneously administered RoActemra/Actemra (tocilizumab) in monotherapy and/or in combination with methotrexa...
This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with giant cell arteritis. Patient...
This open-label, multi-center, two-arm, uncontrolled and non-randomized study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis...
This multicenter study with a randomized, double-blind, parallel-group phase wil l evaluate the safety and efficacy of RoActemra/Actemra (tocilizumab) in combina tion with methotrexate ver...
This open-label, single-arm study will evaluate the safety, efficacy, and tolera bility of subcutaneously administered RoActemra/Actemra (tocilizumab) in monothe rapy or in combination wit...
We present tocilizumab desensitization of a 47-year-old woman affected by rheumatoid arthritis with full body delayed erythematous urticarial reaction. Skin test for tocilizumab gave cutaneous reactio...
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...
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...
Giant cell arteritis is a granulomatous immune-mediated vasculitis of medium and large vessels. It most commonly affects Caucasian females over the age of 50 and is the most common primary vasculitis ...
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...
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.
Antibodies found in adult RHEUMATOID ARTHRITIS patients that are directed against GAMMA-CHAIN IMMUNOGLOBULINS.
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.
Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
Necrotizing VASCULITIS of small and medium size vessels, developing as a complication in RHEUMATOID ARTHRITIS patients. It is characterized by peripheral vascular lesions, cutaneous ULCERS, peripheral GANGRENE, and MONONEURITIS MULTIPLEX.
Cytokine Tumour Necrosis Factor (TNF)
TNF is a compound that is classified as a cytokine which plays a central role in the cellular mechanisms of apoptosis or cell death. However, there are a number of different kinds of TNF, just under twenty, but the family of molecules have very similar a...
Arthroplasty Joint Disorders Orthopedics Spinal Cord Disorders Orthopedics is the science or practice of correcting deformities caused by disease or damage to the bones and joints of the skeleton. This specialized branch of surgery may ...