A Non-Interventional Study of RoActemra/Actemra (Tocilizumab) Treatment in Patients With Rheumatoid Arthritis

Multinational, Multicenter, Non Interventional Study, in Patients With Rheumatoid Arthritis (RA) Treated With Tocilizumab.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01952509

Enrollment

169

Registered

2013-09-30

Start date

2013-10-31

Completion date

2016-09-30

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 multicenter, observational study will evaluate the use and efficacy of RoActemra/Actemra (tocilizumab) in routine clinical practice in patients with moderate to severe rheumatoid arthritis. Eligible patients initiated on RoActemra/Actemra treatment in accordance with the local 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 (1987) ACR criteria * Patients in whom the treating physician has made the decision to commence RoActemra/Actemra treatment (in accordance with the local label); this can include patients who have received RoActemra/Actemra treatment within 8 weeks prior to the enrolment visit

Exclusion criteria

* Patients who have received RoActemra/Actemra more than 8 weeks prior to the enrolment visit * Patients who have previously received RoActemra/Actemra in a clinical trial or for compassionate use * Patients who have received 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 * Patients with a 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 at 6 months after treatment initiation	approximately 2 years

Secondary

Measure	Time frame
Clinical/demographic patient characteristics at initiation of RoActemra/Actemra treatment	approximately 2 years
Proportion of patients on RoActemra/Actemra monotherapy at study entry and at Month 6	approximately 2 years
Efficacy: Response according to total joint count evaluation by DAS28/EULAR/SDAI/CDAI/ACR	approximately 2 years
Safety: Incidence of adverse events	approximately 2 years
Rates of dose modifications/interruptions	approximately 2 years
Visual Analogue Scale - Fatigue	approximately 2 years
Visual Analogue Scale - severity of pain	approximately 2 years
Visual Analogue Scale - morning stiffness	aproximately 2 years
Patient Global Assessment of disease activity	approximately 2 years
Health Assessment Questionnaire Disability Index	approximately 2 years

Countries

Costa Rica, Dominican Republic, Guatemala, Panama

Outcome results