Rheumatoid Arthritis Clinical Trial
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
| NCT number | NCT01483326 |
| Other study ID # | ML25411 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | December 31, 2010 |
| Est. completion date | June 19, 2017 |
| Verified date | April 2019 |
| Source | Hoffmann-La Roche |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 215 |
| Est. completion date | June 19, 2017 |
| Est. primary completion date | June 19, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Netherlands | 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 | Röpcke Zweers ziekenhuis; Reumatologie | Hardenberg | |
| Netherlands | Tergooiziekenhuizen, loc. Hilversum | Hilversum | |
| Netherlands | Medisch Centrum Leeuwarden; Reumatology | Leeuwarden | |
| Netherlands | Maastricht University Medical Centre; Rheumatology | Maastricht | |
| Netherlands | St. Antonius Ziekenhuis; Pharmacy | Nieuwegein | |
| Netherlands | St. Maartenskliniek | Nijmegen | |
| Netherlands | Maasstadziekenhuis; Reumatologie | Rotterdam | |
| Netherlands | Vlietland Hospital | Schiedam | |
| Netherlands | Ziekenhuis Walcheren; Reumatologie | Vlissingen |
| Lead Sponsor | Collaborator |
|---|---|
| Hoffmann-La Roche |
Netherlands,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in disease activity score (DAS 28) | baseline and up to 4 years | ||
| Secondary | Change in disability, assessed by Health Assessment Questionnaire (HAQ) | baseline and up to 4 years | ||
| Secondary | Change in concomitant medication (especially tapering of steroids) | baseline and up to 4 years | ||
| Secondary | Change in dosage schedule (modification/interruption/discontinuation) | baseline and up to 4 years | ||
| Secondary | Safety: Incidence of adverse events | up to 4 years | ||
| Secondary | 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 |
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