Multicenter, Post-marketing, Non-interventional, Observational Study in RA Patients Treated With RoActemra/Actemra (Tocilizumab)

A 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

NCT02101307

Enrollment

400

Registered

2014-04-02

Start date

2014-07-09

Completion date

2017-05-22

Last updated

2017-12-29

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 non-interventional study will observe the usage and efficacy of RoActemra/Actemra in patients with rheumatoid arthritis (RA) who have recently begun treatment. The treatment regimen will be directed by the treating physician according to clinical practice. Patients are expected to be observed for approximately 6 months after beginning treatment.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients at least 18 years of age * Patients with a diagnosis of moderate to severe RA according to the revised (1987) ACR criteria * Patient 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 * Patient has given informed consent

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 investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra * Patients with a 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 6 months after treatment initiation	6 months

Secondary

Measure	Time frame
Record of RA treatment history	6 months
Treatment patterns during observation period, assessed by alteration in dosing regimen	6 months
Proportion of patients with systemic manifestation of RA	At Baseline
Incidence of adverse events	6 months
Health-related quality of life as assessed by questionnaire	6 months
Efficacy as assessed by total joint count evaluation	6 months

Countries

China

Outcome results