An Observational Study on Long-Term Effectiveness and Safety of RoActemra/Actemra (Tocilizumab) in Daily Practice in Patients With Rheumatoid Arthritis (ICHIBAN)

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT01194401
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This prospective, multi-center observational study will assess the long-term efficacy and safety of RoActemra/Actemra in daily practice in patients with active moderate to severe rheumatoid arthritis who have an inadequate response or are intolerant to one or more disease-modifying antirheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists. Data will be collected from patients initiated on RoActemra/Actemra treatment according to label by decision of the treating physician. Anticipated time for data collection from each patient will be 2 years.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-01
• Study First Submitted QC: 2010-09-01
• Study First Posted: 2010-09-03
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3404

Inclusion Criteria

• Adult patients, >/= 18 years of age
• Active moderate to severe rheumatoid arthritis
• Inadequate response or intolerant to previous therapy with one or more disease-modifying antirheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists
• Prescription of RoActemra/Actemra according to label

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Exclusion Criteria

N/A

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients with clinical remission defined as disease activity score DAS28 < 2.6	5 years

Secondary Outcome Measures

Name	Time	Method
Time to good or moderate response according to EULAR criteria	5 years
Dose-modifications and discontinuations of RoActemra/Actemra	5 years
Efficacy of other possible RA therapies in case of inadequate response to RoActemra/Actemra (DAS28, EULAR criteria)	5 years
Safety of other possible RA therapies in case of inadequate response to RoActemra/Actemra (adverse events)	5 years
Safety: Incidence of adverse events	5 years
Proportion of patients with good or moderate response according to EULAR criteria	5 years
Factors related to response (C-reactive protein, rheumatoid factor, inadequate response to DMARDs or anti-TNF, duration of illness)	5 years
Time to DAS28 remission	5 years