An Observational Study on Long-Term Efficacy and Safety of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis (FAct)

Hoffmann-La Roche215 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

215

Conditions

Rheumatoid Arthritis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (19)

Jan Van Breemen Instituut

Amsterdam, Netherlands

Gelre Ziekenhuis; Reumatology

Apeldoorn, Netherlands

Outcomes

Primary Outcomes

Change in disease activity score (DAS 28)

Time frame: baseline and up to 4 years

Secondary Outcomes

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

Data from ClinicalTrials.gov

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