A Multi-National, Multi-Center Non-Interventional Study in Rheumatoid Arthritis (RA) Patients Who Are Treated With Tocilizumab

Hoffmann-La Roche0 sites200 target enrollmentFebruary 2012

ConditionsRheumatoid Arthritis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Enrollment: 200
Primary Endpoint: Percentage of Participants on Tocilizumab Treatment at 6 Months After Treatment Initiation
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

This multi-center, non-interventional study will evaluate the pattern of usage in clinical practice, efficacy and safety of tocilizumab in patients with rheumatoid arthritis. Patients initiated on treatment with tocilizumab according to the licensed Canadian product monograph recommendations will be followed for 12 months from the start of treatment.

Registry

clinicaltrials.gov

Start Date

February 2012

End Date

October 2014

Last Updated

9 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adult patients, \>/= 18 years of age
•Moderate to severe rheumatoid arthritis according to revised (1987) American college of rheumatology (ACR) criteria
•Initiated on tocilizumab treatment by the treating physician in accordance with the Canadian product monograph
•Informed consent to data being subject to computerized data processing
•Participant must fulfill the reimbursement criteria for treatment with tocilizumab under provincial or private health insurance coverage

Exclusion Criteria

•Received tocilizumab prior to enrolment visit
•Previously received tocilizumab in a clinical trial or for compassionate use
•Enrolled in an ongoing clinical trial and/or received treatment with any investigational agent within 4 weeks, or 5 half-lives of the investigational agent, whichever is longer, before starting treatment with tocilizumab
•Participation in another clinical trial or industry sponsored observational study
•History of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis, with the exception of concomitant secondary Sjörgen's syndrome

Outcomes

Primary Outcomes

Percentage of Participants on Tocilizumab Treatment at 6 Months After Treatment Initiation

Time Frame: At 6 months

Secondary Outcomes

Change From Baseline in C-Reactive Protein (CRP)(From baseline to Month 12)
Change From Baseline in Tender Joint Count (TJC)(From baseline to Month 12)
Change From Baseline in Disease Activity Score 28 (DAS28)(From baseline to Month 12)
Number of Participants With Changes in Severity of Extra-Articular Manifestations at 12 Months(At 12 months)
Change From Baseline in Swollen Joint Count (SJC)(From baseline to Month 12)
Change From Baseline in Erythrocyte Sedimentation Rate (ESR)(From baseline to Month 12)
Change From Baseline in Patient Global Assessment of Disease Activity (Visual Analog Scale, VAS)(From baseline to Month 12)
Change From Baseline in Physician Global Assessment of Disease Activity (Visual Analog Scale, VAS)(From baseline to Month 12)
Change From Baseline in Patient Assessment of Fatigue (Visual Analog Scale, VAS)(From baseline to Month 12)
Percentage of Participants With Changes in Extra-Articular Manifestations at 12 Months(At 12 months)
Change From Baseline in Duration of Morning Stiffness (Visual Analog Scale, VAS)(From baseline to Month 12)
Change From Baseline in Patient Assessment of Pain (Visual Analog Scale, VAS)(From baseline to Month 12)