A Non-Interventional Study of RoActemra/Actemra (Tocilizumab) Treatment in Patients With Rheumatoid Arthritis

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT01952509
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This multicenter, observational study will evaluate the use and efficacy of RoActemra/Actemra (tocilizumab) in routine clinical practice in patients with moderate to severe rheumatoid arthritis. Eligible patients initiated on RoActemra/Actemra treatment in accordance with the local label will be followed for 6 months.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-10
• Study First Submitted QC: 2013-09-24
• Study First Posted: 2013-09-30
• Study Start: 2013-10
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 169

Inclusion Criteria

• Adult patients, >/= 18 years of age
• Moderate to severe rheumatoid arthritis according to the revised (1987) ACR criteria
• Patients in whom the treating physician has made the decision to commence RoActemra/Actemra treatment (in accordance with the local label); this can include patients who have received RoActemra/Actemra treatment within 8 weeks prior to the enrolment visit

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Exclusion Criteria

• Patients who have received RoActemra/Actemra more than 8 weeks prior to the enrolment visit
• Patients who have previously received RoActemra/Actemra in a clinical trial or for compassionate use
• Patients who have received 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
• Patients with a 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 at 6 months after treatment initiation	approximately 2 years

Secondary Outcome Measures

Name	Time	Method
Rates of dose modifications/interruptions	approximately 2 years
Clinical/demographic patient characteristics at initiation of RoActemra/Actemra treatment	approximately 2 years
Proportion of patients on RoActemra/Actemra monotherapy at study entry and at Month 6	approximately 2 years
Efficacy: Response according to total joint count evaluation by DAS28/EULAR/SDAI/CDAI/ACR	approximately 2 years
Safety: Incidence of adverse events	approximately 2 years
Health Assessment Questionnaire Disability Index	approximately 2 years
Visual Analogue Scale - Fatigue	approximately 2 years
Visual Analogue Scale - severity of pain	approximately 2 years
Visual Analogue Scale - morning stiffness	aproximately 2 years
Patient Global Assessment of disease activity	approximately 2 years