A Prospective, Non-Interventional Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Active Rheumatoid Arthritis
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This prospective, observational study will evaluate the efficacy, safety and tolerability of RoActemra/Actemra (tocilizumab) in patients with moderate to severe active rheumatoid arthritis who have had an inadequate response or are intolerant to one or more conventional disease-modifying anti-rheumatic drugs. Data will be collected from patients initiated on RoActemra/Actemra treatment according to the local label at baseline, Weeks 4, 12 and 24, and at 3 and 6 months after the last dose of study drug.
A Prospective, Non-interventional Multi-center Observational Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Moderate to Severe Active Rheumatoid Arthritis in Routine Practice
Actual Study Start Date
April 18, 2013
Primary Completion Date
January 25, 2017
Study Completion Date
January 25, 2017
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Safety: Incidence of adverse events [ Time Frame: approximately 3 years ]
Secondary Outcome Measures
Percentage of patients achieving a clinically meaningful improvement in disease activity: DAS28 reduction of at least 1.2 units, low disease activity (DAS28 </= 3.2) or remission (DAS28 <2.6) [ Time Frame: approximately 3 years ]
Clinical/demographic patient characteristics at initiation of RoActemra/Actemra treatment [ Time Frame: approximately 3 years ]
Treatment regimens: Concomitant medications [ Time Frame: approximately 3 years ]
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Ages Eligible for Study:
21 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients with moderate to severe rheumatoid arthritis and an inadequate response or intolerant to previous therapy with conventional DMARDs
Adult patients, >/= 21 years of age
Moderate to severe active rheumatoid arthritis (DAS28 >/= 3.2)
Inadequate response to one or more conventional disease-modifying anti-rheumatic drugs (DMARDs)
Initiated on RoActemra/Actemra treatment in accordance with the prescribing information
Pregnant or lactating women
Contra-indication to RoActemra/Actemra treatment according to the local labelling
Previous treatment with tocilizumab
Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra
Women of childbearing potential not using effective methods of contraception as defined by protocol