An Observational Study of Glucocorticoid Use in Patients With Rheumatoid Arthritis on Treatment With RoActemra/Actemra (Tocilizumab)

Evaluation of Glucocorticoid Sparing Effect in Patients Receiving RoActemra® for Rheumatoid Arthritis in Real Life.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01392001

Enrollment

322

Registered

2011-07-12

Start date

2011-03-31

Completion date

2013-04-30

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 observational study will evaluate the glucocorticoid sparing effect after 12 months of treatment with RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Data will be collected for 12 months after the initiation of treatment with RoActemra/Actemra from patients who had been on treatment with \>5 mg prednisone or equivalent for at least 3 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 for whom the rheumatologist decided to introduce RoActemra * Patients taking more than 5 mg/day of oral prednisone (or equivalent) for at least 3 months

Exclusion criteria

* Participation in a clinical trial in rheumatoid arthritis

Design outcomes

Primary

Measure	Time frame
Percentage of patients receiving </= 5 mg/day prednisone (or equivalent) after 12 months of treatment with RoActemra/Actemra	approximately 29 months

Secondary

Measure	Time frame
Efficacy: Disease activity score (DAS 28)	approximately 29 months
Co-medications: dosage and treatment schedules	approximately 29 months
Patient reported outcome: European League against Rheumatism - Rheumatoid Arthritis Impact of Disease score (EULAR-RAID)/Health Assessment Questionnaire - Disease Index (HAQ-DI)	approximately 29 months
Safety: Incidence of adverse events	approximately 29 months

Countries

France

Outcome results