An Observational Study on Long-Term Efficacy and Safety of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis (FAct)
FAct: A Non-interventional Multi-center Study to Follow Patients Starting With RoActemra Assessing the Long Term Efficacy, Effectiveness and Safety of RoActemra
1 other identifier
observational
215
1 country
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2010
Longer than P75 for all trials
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 31, 2010
CompletedFirst Submitted
Initial submission to the registry
November 23, 2011
CompletedFirst Posted
Study publicly available on registry
December 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 19, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 19, 2017
CompletedMay 1, 2019
April 1, 2019
6.5 years
November 23, 2011
April 29, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Change in disease activity score (DAS 28)
baseline and up to 4 years
Secondary Outcomes (5)
Change in disability, assessed by Health Assessment Questionnaire (HAQ)
baseline and up to 4 years
Change in concomitant medication (especially tapering of steroids)
baseline and up to 4 years
Change in dosage schedule (modification/interruption/discontinuation)
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
Study Arms (1)
Cohort
Eligibility Criteria
Participants in the ACT SURE clinical trial or patients with moderate to severe rheumatoid arthritis starting or receiving RoActemra/Actemra
You may qualify if:
- 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
You may not qualify if:
- Contra-indications for RoActemra/Actemra
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Jan Van Breemen Instituut
Amsterdam, 1056 AB, Netherlands
Gelre Ziekenhuis; Reumatology
Apeldoorn, 7300 DS, Netherlands
Rijnstate Ziekenhuis; Afdeling Reumatologie
Arnhem, 6815 AD, Netherlands
Amphia ziekenhuis, locatie langendijk
Breda, 4819 EV, Netherlands
Deventer ziekenhuis
Deventer, 7416 SE, Netherlands
MC groep - locatie Emmeloord
Emmeloord, 8300 GA, Netherlands
Scheper Ziekenhuis
Emmen, 7824 AA, Netherlands
Medisch Centrum Twente; Rheumatology
Enschede, 7511 JX, Netherlands
Ziekenhuis Walcheren; Reumatologie
Flushing, 4382 EE, Netherlands
Groene Hart Ziekenhuis
Gouda, 2803 HH, Netherlands
Röpcke Zweers ziekenhuis; Reumatologie
Hardenberg, 7772 SE, Netherlands
Tergooiziekenhuizen, loc. Hilversum
Hilversum, 1213 HX, Netherlands
Medisch Centrum Leeuwarden; Reumatology
Leeuwarden, 8934 AD, Netherlands
Maastricht University Medical Centre; Rheumatology
Maastricht, 6202 ZA, Netherlands
St. Antonius Ziekenhuis; Pharmacy
Nieuwegein, 3435 CM, Netherlands
St. Maartenskliniek
Nijmegen, 6522 JV, Netherlands
Maasstadziekenhuis; Reumatologie
Rotterdam, 3079 DZ, Netherlands
Vlietland Hospital
Schiedam, 3118 JH, Netherlands
Leyenburg Ziekenhuis; Internal Medecine
The Hague, 2545 CH, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 23, 2011
First Posted
December 1, 2011
Study Start
December 31, 2010
Primary Completion
June 19, 2017
Study Completion
June 19, 2017
Last Updated
May 1, 2019
Record last verified: 2019-04