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

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT01392001
• Lead Sponsor: Hoffmann-La Roche

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 .

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-07-08
• Study First Submitted QC: 2011-07-11
• Study First Posted: 2011-07-12
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 322

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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
Efficacy: Disease activity score (DAS 28)	approximately 29 months
Co-medications: dosage and treatment schedules	approximately 29 months
Safety: Incidence of adverse events	approximately 29 months