An Observational Study in Rheumatoid Arthritis Patients Treated With RoActemra/Actemra (Tocilizumab)

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT01565122
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This multi-center, observational study will evaluate the clinical practice patterns, efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Data will be collected from each eligible patient initiated on RoActemra/Actemra treatment by their treating physician according to approved label for up to 12 months from start of treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-26
• Study First Submitted QC: 2012-03-26
• Study First Posted: 2012-03-28
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

• Adult patients, >/= 18 years of age
• Moderate to severe rheumatoid arthritis
• Patients for whom the treating physician has made the decision to commence RoActemra/Actemra treatment. In Group A RoActemra/Actemra has been prescribed within 8 weeks prior to the enrolment visit. In Group B RoActemra/Actemra has been started more than 8 weeks before inclusion in the study, but not before January 2011

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Exclusion Criteria

• RoActemra/Actemra treatment more than 8 weeks prior to inclusion visit for Group A, before January 2011 for Group B
• Previous RoActemra/Actemra treatment in a clinical trial or for compassionate use
• 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
• History of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients on RoActemra/Actemra treatment at 6 months	approximately 2.5 years

Secondary Outcome Measures

Name	Time	Method
Rates of dose modifications/interruptions	approximately 2.5 years
Clinical/demographic patient characteristics at initiation of RoActemra/Actemra treatment	approximately 2.5 years
Efficacy: Response according to joint count evaluation by DAS28/EULAR/SDAI/CDAI/ACR	approximately 2.5 years
Efficacy: Monotherapy versus combination therapy	approximately 2.5 years
Safety: Incidence of adverse events	approximately 2.5 years
Quality of life: Patient global assessment of disease activity/VAS-Fatigue/VAS-Pain scales	approximately 2.5 years