A Retrospective Observational Study on Compliance in Patients With Rheumatoid Arthritis on Treatment With RoActemra/Actemra (Tocilizumab) in Clinical Practice (REMISSION II)

Multicenter REtrospective Study to Evaluate coMpliance to Therapy and Drug survIval of Tocilizumab (TCZ) in patientS With Moderate to Severe actIve rheumatOid Arthritis in routiNe Daily Clinical Practice (REMISSION II Study)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01649817

Enrollment

183

Registered

2012-07-25

Start date

2012-05-31

Completion date

2013-05-31

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 multicenter, retrospective observational study will evaluate compliance an reasons for withdrawal in patients with moderate to severe active rheumatoid arthritis on treatment with intravenous RoActemra/Actemra (tocilizumab) in daily clinical practice. Data will be collected from each eligible patient over a period of 6 months.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

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 according to the revised 1987 ACR criteria at baseline * RoActemra/Actemra treatment must have been initiated 6 months prior to ICF signing * Patient eligible according to the summary of product characteristics (SPC) and routine clinical practice/European recommendations for the use of biologic DMARDs for the treatment of rheumatoid arthritis

Exclusion criteria

* Rheumatic autoimmune disease other than RA * Participation in interventional clinical trials during the observational period

Design outcomes

Primary

Measure	Time frame
Percentage of patients on RoActemra/Actemra at 6 months after initiating treatment	12 months

Secondary

Measure	Time frame
Frequency of withdrawal (according to reasons)	12 months
Frequency of dose modifications	12 months
Change in disease activity (DAS28)	from baseline to Month 6 or withdrawal, whichever comes first

Countries

Greece

Outcome results