An Observational Study in Rheumatoid Arthritis Patients Treated With RoActemra/Actemra (Tocilizumab)

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01565122

Enrollment

Registered

2012-03-28

Start date

2012-03-31

Completion date

2014-05-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Proportion of patients on RoActemra/Actemra treatment at 6 months	approximately 2.5 years

Secondary

Measure	Time frame
Clinical/demographic patient characteristics at initiation of RoActemra/Actemra treatment	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
Safety: Incidence of adverse events	approximately 2.5 years
Quality of life: Patient global assessment of disease activity/VAS-Fatigue/VAS-Pain scales	approximately 2.5 years
Efficacy: Monotherapy versus combination therapy	approximately 2.5 years

Countries

Finland

Outcome results