Status:
COMPLETED
U-Act-After: An Observational Study on Long-Term Efficacy of Tight Control RoActemra/Actemra (Tocilizumab) and/or Methotrexate in Patients With Early Rheumatoid Arthritis Who Have Participated in the U-Act-Early Study (ML22497)
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
20+ years
Brief Summary
This non-interventional, observational, open-label multi-center follow-up study of patients from the U-Act-Early trial (ML22497) will evaluate the long-term efficacy and safety of starting tight contr...
Eligibility Criteria
Inclusion
- Patients must have participated in the U-Act-Early trial (ML22497); these are adult patients (\> 20 years of age) with rheumatoid arthritis.
- Patients must be willing to give written informed consent
Exclusion
- Patients who did not participate in the U-Act-Early trial
- Patients who are drop-outs in the U-Act-Early trial due to withdrawal of consent, are lost to follow-up or are serious protocol violators
Key Trial Info
Start Date :
April 10 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 10 2017
Estimated Enrollment :
226 Patients enrolled
Trial Details
Trial ID
NCT01918267
Start Date
April 10 2012
End Date
October 10 2017
Last Update
May 11 2018
Active Locations (19)
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1
Medisch Centrum Alkmaar
Alkmaar, Netherlands, 1815 JD
2
Meander Medisch Centrum; Locatie Lichtenberg
Amersfoort, Netherlands, 3818 ES
3
Gelre Ziekenhuis Apeldoorn, Lokatie Lukas; Afdeling Interne Geneeskunde
Apeldoorn, Netherlands, 7334 DZ
4
Amphia Ziekenhuis
Breda, Netherlands, 4819 EV