Overview

This trial is active, not recruiting.

Condition rheumatoid arthritis
Sponsor Hoffmann-La Roche
Trial size 3404 participants
Trial identifier NCT01194401, ML22928

Summary

This prospective, multi-center observational study will assess the long-term efficacy and safety of RoActemra/Actemra in daily practice in patients with active moderate to severe rheumatoid arthritis who have an inadequate response or are intolerant to one or more disease-modifying antirheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists. Data will be collected from patients initiated on RoActemra/Actemra treatment according to label by decision of the treating physician. Anticipated time for data collection from each patient will be 2 years.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm

Primary Outcomes

Measure
Proportion of patients with clinical remission defined as disease activity score DAS28 < 2.6
time frame: 5 years

Secondary Outcomes

Measure
Time to DAS28 remission
time frame: 5 years
Proportion of patients with good or moderate response according to EULAR criteria
time frame: 5 years
Time to good or moderate response according to EULAR criteria
time frame: 5 years
Factors related to response (C-reactive protein, rheumatoid factor, inadequate response to DMARDs or anti-TNF, duration of illness)
time frame: 5 years
Dose-modifications and discontinuations of RoActemra/Actemra
time frame: 5 years
Safety: Incidence of adverse events
time frame: 5 years
Efficacy of other possible RA therapies in case of inadequate response to RoActemra/Actemra (DAS28, EULAR criteria)
time frame: 5 years
Safety of other possible RA therapies in case of inadequate response to RoActemra/Actemra (adverse events)
time frame: 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Adult patients, >/= 18 years of age - Active moderate to severe rheumatoid arthritis - Inadequate response or intolerant to previous therapy with one or more disease-modifying antirheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists - Prescription of RoActemra/Actemra according to label Exclusion Criteria:

Additional Information

Official title A Prospective, Non-interventional Multi-center Observational Study to Evaluate the Long-term Effectiveness and Safety of Tocilizumab in Patients With Active Rheumatoid Arthritis in Daily Practice
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.