Overview

This trial is active, not recruiting.

Condition rheumatoid arthritis
Sponsor Hoffmann-La Roche
Start date December 2010
End date February 2017
Trial size 215 participants
Trial identifier NCT01483326, ML25411

Summary

This observational study will evaluate the long-term efficacy and safety of RoActemra/Actemra (tocilizumab in participants of the ACT SURE clinical trial and further patients with moderate to severe rheumatoid arthritis starting or receiving RoActemra/Actemra. Data will be collected from each patient for up to 4 years.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm

Primary Outcomes

Measure
Change in disease activity score (DAS 28)
time frame: baseline and up to 4 years

Secondary Outcomes

Measure
Change in disability, assessed by Health Assessment Questionnaire (HAQ)
time frame: baseline and up to 4 years
Change in concomitant medication (especially tapering of steroids)
time frame: baseline and up to 4 years
Change in dosage schedule (modification/interruption/discontinuation)
time frame: baseline and up to 4 years
Safety: Incidence of adverse events
time frame: up to 4 years
Response (DAS 28) according to patient-related factors (C-reactive protein, rheumatoid factor, inadequate response to anti-TNF/DMARDs, duration of illness)
time frame: up to 4 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Adult patients, >18 years of age - Participants in the ACT-SURE trial, or patients with moderate to severe rheumatoid arthritis starting or receiving RoActemra/Actemra Exclusion Criteria: - Contra-indications for RoActemra/Actemra

Additional Information

Official title FAct: A Non-interventional Multi-center Study to Follow Patients Starting With RoActemra Assessing the Long Term Efficacy, Effectiveness and Safety of RoActemra
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.