A Non-Interventional Study in Patients With Rheumatoid Arthritis Who Are Treated With RoActemra/Actemra (Tocilizumab)

Withdrawn

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT01893255
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2013-07-02
• Study First Submitted QC: 2013-07-05
• Study First Posted: 2013-07-08
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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
• Patients who for any reason do not take methotrexate and the treating physician has made a decision to prescribe RoActemra/Actemra as monotherapy
• Patients who were previously on a TNF inhibitor as monotherapy, and the treating physician has made a decision to prescribe RoActemra/Actemra as monotherapy
• Concomitant treatment with corticosteroids (orally and intra-articularly) and/or NSAIDs is allowed

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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 receiving concomitant DMARD treatment for rheumatoid arthritis (e.g. hydroxychloroquine, sulfasalazine, methotrexate, leflunomide, gold compounds, cyclosporine)
• Patients who have received treatment with an 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	Month 6

Secondary Outcome Measures

Name	Time	Method
Clinical/demographic patient characteristics at initiation of RoActemra/Actemra treatment	approximately 6 months
Rates of dose modifications/interruptions	approximately 6 months
Efficacy: Response according to total joint count evaluation by DAS28/EULAR/SDAI/CDAI/ACR	approximately 6 months
Physician's Global Assessment of Disease Activity	approximately 6 months
Safety: Incidence of adverse events	approximately 6 months
Patient reported outcomes (Patient Global Assessment of disease activity, HAQ-DI, VAS-Fatigue, severity of pain and morning stiffness)	approximately 6 months