Clinical trial NCT01483326: An Observational Study on Long-Term Efficacy and Safety of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis (FAct)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-12-01
Enrollment: 215
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants in the ACT SURE clinical trial or patients with moderate to severe rheumatoid arthritis starting or receiving RoActemra/Actemra

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in disease activity score (DAS 28)
timeFrame: baseline and up to 4 years
Secondary outcomes:
measure: Change in disability, assessed by Health Assessment Questionnaire (HAQ)
timeFrame: baseline and up to 4 years
measure: Change in concomitant medication (especially tapering of steroids)
timeFrame: baseline and up to 4 years
measure: Change in dosage schedule (modification/interruption/discontinuation)
timeFrame: baseline and up to 4 years
measure: Safety: Incidence of adverse events
timeFrame: up to 4 years
measure: Response (DAS 28) according to patient-related factors (C-reactive protein, rheumatoid factor, inadequate response to anti-TNF/DMARDs, duration of illness)
timeFrame: up to 4 years
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Jan Van Breemen Instituut
city: Apeldoorn
country: Netherlands
facility: Gelre Ziekenhuis; Reumatology
city: Arnhem
country: Netherlands
facility: Rijnstate Ziekenhuis; Afdeling Reumatologie
city: Breda
country: Netherlands
facility: Amphia ziekenhuis, locatie langendijk
city: Den Haag
country: Netherlands
facility: Leyenburg Ziekenhuis; Internal Medecine
city: Deventer
country: Netherlands
facility: Deventer ziekenhuis
city: Emmeloord
country: Netherlands
facility: MC groep - locatie Emmeloord
city: Emmen
country: Netherlands
facility: Scheper Ziekenhuis
city: Enschede
country: Netherlands
facility: Medisch Centrum Twente; Rheumatology
city: Gouda
country: Netherlands
facility: Groene Hart Ziekenhuis
city: Hardenberg
country: Netherlands
facility: Röpcke Zweers ziekenhuis; Reumatologie
city: Hilversum
country: Netherlands
facility: Tergooiziekenhuizen, loc. Hilversum
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden; Reumatology
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre; Rheumatology
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis; Pharmacy
city: Nijmegen
country: Netherlands
facility: St. Maartenskliniek
city: Rotterdam
country: Netherlands
facility: Maasstadziekenhuis; Reumatologie
city: Schiedam
country: Netherlands
facility: Vlietland Hospital
city: Vlissingen
country: Netherlands
facility: Ziekenhuis Walcheren; Reumatologie
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: