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

Hoffmann-La Roche23 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Rheumatoid Arthritis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 Exclusion Criteria: * Patients previously treated with RoActemra/Actemra * Any contraindication to RoActemra/Actemra

Locations (13)

Unnamed facility

Vitoria-Gasteiz, Alava, Spain

Unnamed facility

Alicante, Alicante, Spain

Unnamed facility

Elche, Alicante, Spain

Unnamed facility

Palma de Mallorca, Balearic Islands, Spain

Outcomes

Primary Outcomes

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

Time frame: Week 36

Secondary Outcomes

Change from baseline in glucocorticoid dose

Time frame: Week 36

Change from baseline in corticosteroid dose

Time frame: Week 36

Proportion of patients treated with RoActemra/Actemra who reach Week 36 with a reduced glucocorticoid dose

Time frame: Week 36

Proportion of patients treated with RoActemra/Actemra not receiving glucocorticoids

Time frame: Week 36

Proportion of concomitant disease-modifying anti-rheumatic drug (DMARD) use

Time frame: 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

Time frame: 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

Time frame: Week 36

Proportion of patients meeting the physician's recommendaitons for glucocorticoid dose reduction

Time frame: Week 36

Percentage change in Disease Activity Score 28 (DAS28)

Data from ClinicalTrials.gov

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