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

A Prospective Observational Study to Assess the Impact of RoActemra® on the Use of Glucocorticoids in Patients With Rheumatoid Arthritis Treated With the Standard of Care.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01564901

Enrollment

Registered

2012-03-28

Start date

2012-01-31

Completion date

2012-10-31

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 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.

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

* 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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Change from baseline in corticosteroid dose	Week 36
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
Proportion of patients meeting the physician's recommendaitons for glucocorticoid dose reduction	Week 36
Percentage change in Disease Activity Score 28 (DAS28)	Week 36
Percentage change in Simplified Disease Activity Index (SDAI) score	Week 36
Safety: Incidence of adverse events	36 weeks
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

Countries

Spain

Outcome results