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
Actual Primary Completion Date :
January 25, 2017
Actual 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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Layout table for eligibility information
Ages Eligible for Study:
21 Years and older (Adult, Older Adult)
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