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

Terminated

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT01643863
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This multi-center observational study will evaluate the use of RoActemra/Actemra (tocilizumab) in monotherapy in patients with rheumatoid arthritis. Eligible patients initiated on RoActemra/Actemra treatment according to the licensed label will be followed for 6 months.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-07-16
• Study First Submitted QC: 2012-07-16
• Study First Posted: 2012-07-18
• Study Start: 2012-08
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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 monotherapy, in case of methotrexate intolerance or when continuous methotrexate treatment is inadequate (in accordance with the local label), and who have received (or started) RoActemra/Actemra monotherapy treatment within 8 weeks prior to the enrolment visit.
• Concomitant corticosteroids (oral or intra-articular) or non-steroidal anti-inflammatory drugs (NSAIDs) are allowed

Exclusion Criteria

• Patients in whom RoActemra/Actemra is contraindicated according to the approved Summary of Product Characteristics
• 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
• Concomitant DMARD treatment for rheumatoid arthritis (e.g. hydroxychloroquine, sulfasalazine, methotrexate, leflunomide, gold compounds, cyclosporine) when starting treatment with RoActemra/Actemra
• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients on RoActemra/Actemra at 6 months	approximately 20 months

Secondary Outcome Measures

Name	Time	Method
Clinical/demographic patient characteristics at initiation of RoActemra/Actemra treatment	approximately 20 months
Rates of dose modifications/interruptions	approximately 20 months
Introduction/use of disease-modifying anti-rheumatic drugs (DMARDs)	approximately 20 months
Safety: Incidence of adverse events\n	approximately 20 months
Efficacy: Response according to total joint count evaluation by DAS28/EULAR/SDAI/CDAI/ACR	approximately 20 months
Patient reported outcomes: Health Assessment Questionnaires	approximately 20 months
Time to reduction/withdrawal of corticosteroids	approximately 20 months
Physician Global Assessment of disease activity	approximately 20 months