An Observational, Non-interventional, Multi-national Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab

Hoffmann-La Roche0 sites51 target enrollmentMarch 2012

ConditionsRheumatoid Arthritis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Enrollment: 51
Primary Endpoint: Proportion of patients on RoActemra/Actemra treatment at 6 months
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2012

End Date

May 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
•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

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

Outcomes

Primary Outcomes

Proportion of patients on RoActemra/Actemra treatment at 6 months

Time Frame: approximately 2.5 years

Secondary Outcomes

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