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

Tocilizumab (RoActemra) poST Marketing Observational Study in DMARD-IR Patients to Assess Efficacy and Safety in routiNE Clinical Practice - STONE

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01277328

Enrollment

Registered

2011-01-14

Start date

2010-05-31

Completion date

2014-08-31

Last updated

2016-09-15

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 observational, prospective, open-label, multi-center study will evaluate the effectiveness in disease reduction and the safety of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Data will be collected for 11 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 * Patients with rheumatoid arthritis eligible for RoActemra

Exclusion criteria

* Hypersensitivity to RoActemra * Active, severe infections

Design outcomes

Primary

Measure	Time frame
Mean change in Disease Activity Score 28 (DAS28)	11 months

Secondary

Measure	Time frame
Proportion of patients with a change in Disease Activity Score 28 (DAS28)	5 months
European League Against Rheumatism (EULAR) response rates	20 weeks
Proportion of patients with disease remission	20 weeks
Proportion of patients with low disease activity	20 weeks
Incidence of adverse events	11 months

Countries

Romania

Outcome results