An Observational Study on Long-Term Efficacy and Safety of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis (FAct)
- Conditions
- Rheumatoid Arthritis
- Registration Number
- NCT01483326
- Lead Sponsor
- Hoffmann-La Roche
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 215
- 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
- Contra-indications for RoActemra/Actemra
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in disease activity score (DAS 28) baseline and up to 4 years
- Secondary Outcome Measures
Name Time Method Change in concomitant medication (especially tapering of steroids) baseline and up to 4 years Safety: Incidence of adverse events 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) up to 4 years Change in disability, assessed by Health Assessment Questionnaire (HAQ) baseline and up to 4 years Change in dosage schedule (modification/interruption/discontinuation) baseline and up to 4 years
Trial Locations
- Locations (19)
Jan Van Breemen Instituut
🇳🇱Amsterdam, Netherlands
Gelre Ziekenhuis; Reumatology
🇳🇱Apeldoorn, Netherlands
Rijnstate Ziekenhuis; Afdeling Reumatologie
🇳🇱Arnhem, Netherlands
Amphia ziekenhuis, locatie langendijk
🇳🇱Breda, Netherlands
Leyenburg Ziekenhuis; Internal Medecine
🇳🇱Den Haag, Netherlands
Deventer ziekenhuis
🇳🇱Deventer, Netherlands
MC groep - locatie Emmeloord
🇳🇱Emmeloord, Netherlands
Scheper Ziekenhuis
🇳🇱Emmen, Netherlands
Medisch Centrum Twente; Rheumatology
🇳🇱Enschede, Netherlands
Groene Hart Ziekenhuis
🇳🇱Gouda, Netherlands
Scroll for more (9 remaining)Jan Van Breemen Instituut🇳🇱Amsterdam, Netherlands