An Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to DMARDs

DAS Evaluation of RA Activity in Patients Treated With Tocilizumab

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01388309

Enrollment

Registered

2011-07-06

Start date

2011-07-31

Completion date

2013-03-31

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 observational study will evaluate in clinical practice the change in Disease Activity Score (DAS28) in patients with rheumatoid arthritis and an inadequate response to DMARDs who are initiated on treatment with RoActemra/Actemra (tocilizumab). Data will be collected from eligible patients (on 8 mg/kg or 4 mg/kg intravenously every 4 weeks, with or without methotrexate) for 12 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 active rheumatoid arthritis * Inadequate response or intolerance to previous therapy with one or more traditional DMARDs

Exclusion criteria

* Pregnant or lactating women * Active infection * Positive for hepatitis B, hepatitis C or HIV infection * Concomitant anti-TNF drugs * Contraindications to treatment with RoActemra/Actemra

Design outcomes

Primary

Measure	Time frame
Disease activity score (DAS28)	12 months

Secondary

Measure	Time frame
DAS 28 (subgroup on monotherapy)	12 months
DAS 28 (subgroup on 4 mg/kg dose)	12 months
Safety: Incidence of adverse events	12 months

Countries

Slovakia

Outcome results