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

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT01564901
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This prospective, observational, multicenter study will assess the efficacy and safety of RoActemra/Actemra (tocilizumab) on the use of glucocorticoids in patients with moderate to severe rheumatoid arthritis and an inadequate response to previous disease-modifying antirheumatic drugs or anti-TNF. Data will be collected for 36 weeks.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-02-16
• Study First Submitted QC: 2012-03-27
• Study First Posted: 2012-03-28
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• Adults patients, over 18 years of age
• Patients with moderate to severe rheumatoid arthritis (RA)
• Patients on a stable dose of prednisone or equivalent (>/=7.5 mg/day) for at least 4 weeks before study inclusion

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Exclusion Criteria

• Patients previously treated with RoActemra/Actemra
• Any contraindication to RoActemra/Actemra

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients on treatment with RoActemra/Actemra who achieve prednisone (or equivalent) dose reduction of </= 5mg/day	Week 36

Secondary Outcome Measures

Name	Time	Method
Proportion of patients treated with RoActemra/Actemra who reach Week 36 with a reduced glucocorticoid dose	Week 36
Proportion of patients treated with RoActemra/Actemra not receiving glucocorticoids	Week 36
Proportion of concomitant disease-modifying anti-rheumatic drug (DMARD) use	Week 36
Proportion of patients with inadequate response to prior treatment with disease-modifying antirheumatic drugs at baseline, who reach a prednisone (or equivalent) dose reduction of </= 5 mg/day	Week 36
Change from baseline in glucocorticoid dose	Week 36
Change from baseline in corticosteroid dose	Week 36
Percentage change in Disease Activity Score 28 (DAS28)	Week 36
Proportion of patients with inadequate response to prior treatment with anti-TNF at baseline, who reach a glucocorticoid dose reduction of </= 5 mg/day	Week 36
Proportion of patients meeting the physician's recommendaitons for glucocorticoid dose reduction	Week 36
Percentage change in Simplified Disease Activity Index (SDAI) score	Week 36
Safety: Incidence of adverse events	36 weeks