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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01615419

Enrollment

Registered

2012-06-08

Start date

2012-05-31

Completion date

2013-11-30

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 use in clinical practice and efficacy of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Eligible patients initiated on RoActemra/Actemra treatment according to the approved label will be followed for 6 months.

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 , according to the revised ACR criteria * Patients initiated on RoActemra/Actemra treatment (in accordance with the local label) on their treating physicians decision

Exclusion criteria

* RoActemra/Actemra treatment more than 8 weeks prior to enrolment visit * 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 investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra * History of autoimmune disease or of any joint inflammatory disease other than RA

Design outcomes

Primary

Measure	Time frame
Proportion of patients on RoActemra/Actemra treatment at 6 months	approximately 2 years

Secondary

Measure	Time frame
Rates of dose modifications/interruptions	approximately 2 years
Clinical/demographic patient characteristics at initiation of treatment	approximately 2 years
Efficacy: Response according to total joint count evaluation by DAS28/EULAR/SDAI/CDAI/ACR	approximately 2 years
Efficacy: Monotherapy versus combination therapy	approximately 2 years
Use of disease-modifying anti-rheumatic drugs (DMARDs)	approximately 2 years

Countries

Greece

Outcome results