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A Study of Tocilizumab as Monotherapy and in Combination With Methotrexate Versus Methotrexate in Patients With Early Moderate to Severe Rheumatoid Arthritis

2014-08-27 03:18:14 | BioPortfolio

Summary

This randomized, double-blind, parallel group study will assess the safety, disease remission and prevention of structural joint damage on treatment with tocilizumab as monotherapy or in combination with methotrexate, versus methotrexate in patients with early moderate to severe rheumatoid arthritis. Patients will be randomized to receive either A) tocilizumab (8mg/kg iv every 4 weeks) plus placebo, or B) tocilizumab (8mg/kg iv every 4 weeks) plus methotrexate (7.5-20mg po weekly), or C) tocilizumab (4mg/kg iv every 4 weeks) plus methotrexate (7.5-20mg po weekly), or D) placebo plus methotrexate (7.5-20mg po weekly). Patients in groups C and D who have not achieved low disease activity at week 52 can receive tocilizumab 8mg/kg iv every 4 weeks. Anticipated time on study treatment is 104 weeks and target sample size is >1'000 individuals

Study Design

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

Conditions

Rheumatoid Arthritis

Intervention

tocilizumab [RoActemra/Actemra], tocilizumab [RoActemra/Actemra], methotrexate

Location

Aniston
Alabama
United States
36207

Status

Recruiting

Source

Hoffmann-La Roche

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:18:14-0400

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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.

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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.

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.

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.

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