Overview

This trial has been completed.

Condition rheumatoid arthritis
Sponsor Hoffmann-La Roche
Start date October 2013
End date September 2016
Trial size 169 participants
Trial identifier NCT01952509, ML28747

Summary

This multicenter, observational study will evaluate the use and efficacy of RoActemra/Actemra (tocilizumab) in routine clinical practice in patients with moderate to severe rheumatoid arthritis. Eligible patients initiated on RoActemra/Actemra treatment in accordance with the local label will be followed for 6 months.

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 on RoActemra/Actemra at 6 months after treatment initiation
time frame: approximately 2 years

Secondary Outcomes

Measure
Rates of dose modifications/interruptions
time frame: approximately 2 years
Clinical/demographic patient characteristics at initiation of RoActemra/Actemra treatment
time frame: approximately 2 years
Proportion of patients on RoActemra/Actemra monotherapy at study entry and at Month 6
time frame: approximately 2 years
Efficacy: Response according to total joint count evaluation by DAS28/EULAR/SDAI/CDAI/ACR
time frame: approximately 2 years
Safety: Incidence of adverse events
time frame: approximately 2 years
Health Assessment Questionnaire Disability Index
time frame: approximately 2 years
Visual Analogue Scale - Fatigue
time frame: approximately 2 years
Visual Analogue Scale - severity of pain
time frame: approximately 2 years
Visual Analogue Scale - morning stiffness
time frame: aproximately 2 years
Patient Global Assessment of disease activity
time frame: approximately 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Adult patients, >/= 18 years of age - Moderate to severe rheumatoid arthritis according to the revised (1987) ACR criteria - Patients in whom the treating physician has made the decision to commence RoActemra/Actemra treatment (in accordance with the local label); this can include patients who have received RoActemra/Actemra treatment within 8 weeks prior to the enrolment visit Exclusion Criteria: - Patients who have received RoActemra/Actemra more than 8 weeks prior to the enrolment visit - Patients who have previously received RoActemra/Actemra in a clinical trial or for compassionate use - Patients who have received treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra - Patients with a history of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis

Additional Information

Official title Multinational, Multicenter, Non Interventional Study, in Patients With Rheumatoid Arthritis (RA) Treated With Tocilizumab.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.