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)
1 other identifier
observational
226
1 country
19
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 control treatment with RoActemra/Actemra (tocilizumab) and/or methotrexate in patients early in the disease followed by treatment according to standard of care in routine clinical practice in a three year follow-up, independently of what treatment the patient will be receiving.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2012
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
April 10, 2012
CompletedFirst Submitted
Initial submission to the registry
August 6, 2013
CompletedFirst Posted
Study publicly available on registry
August 7, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 10, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 10, 2017
CompletedMay 11, 2018
May 1, 2018
5.5 years
August 6, 2013
May 10, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Disease Activity Score (DAS28)
from baseline to Month 36
Secondary Outcomes (6)
Change in disability, assessed by the Dutch consensus Health Assessment Questionnaire (HAQ)
from baseline to Month 36
Measure of progressive joint destruction (vdHSS)
from baseline of U-Act-Early to Month 24 of U-Act-After
Changes in concomitant medication (especially tapering of corticosteroids)
from baseline to Months 36
Sustained remission rates/drug-free remission rates
36 months
Dose modifications/interruptions of RA treatment
36 months
- +1 more secondary outcomes
Study Arms (1)
Cohort
Eligibility Criteria
Patients who participated in the U Act Early study (ML22497)
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Medisch Centrum Alkmaar
Alkmaar, 1815 JD, Netherlands
Meander Medisch Centrum; Locatie Lichtenberg
Amersfoort, 3818 ES, Netherlands
Gelre Ziekenhuis Apeldoorn, Lokatie Lukas; Afdeling Interne Geneeskunde
Apeldoorn, 7334 DZ, Netherlands
Amphia Ziekenhuis
Breda, 4819 EV, Netherlands
Rivas Zorggroep, Locatie Beatrixziekenhuis; Reumatologie
Gorinchem, 4204 AA, Netherlands
Groene Hart Ziekenhuis
Gouda, 2803 HH, Netherlands
Universitair Medisch Centrum Groningen; Department of Rheumatology
Groningen, 9700RB, Netherlands
Kennemer Gasthuis; Inwendige Geneeskunde
Haarlem, 2035RC, Netherlands
Atrium Medisch Centrum; Nephrology
Heerlen, 6419 PC, Netherlands
Tergooiziekenhuizen, loc. Hilversum
Hilversum, 1213 HX, Netherlands
Spaarne Ziekenhuis; Inwendige Geneeskunde
Hoofddorp, 2134 TM, Netherlands
Medisch Centrum Leeuwarden; Reumatology
Leeuwarden, 8934 AD, Netherlands
Academisch Ziekenhuis Leiden; Dept of Rheumatology
Leiden, 2333 ZA, Netherlands
Ijsselmeer Ziekenhuizen; Interne Geneeskunde
Lelystad, 8233 AA, Netherlands
St. Antonius Ziekenhuis Nieuwegein
Nieuwegein, 3430 EM, Netherlands
St. Maartenskliniek
Nijmegen, 6522 JV, Netherlands
Antonius Ziekenhuis Sneek; Department of Rheumatology
Sneek, 8601 ZK, Netherlands
University Medical Centre Utrecht; Reumatologie en Klinische Immunologie
Utrecht, 3584 GA, Netherlands
Maartenskliniek Woerden
Woerden, 3447 GN, 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
August 6, 2013
First Posted
August 7, 2013
Study Start
April 10, 2012
Primary Completion
October 10, 2017
Study Completion
October 10, 2017
Last Updated
May 11, 2018
Record last verified: 2018-05