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)
- Conditions
- Rheumatoid Arthritis
- Registration Number
- NCT01918267
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 226
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in Disease Activity Score (DAS28) from baseline to Month 36
- Secondary Outcome Measures
Name Time Method Change in disability, assessed by the Dutch consensus Health Assessment Questionnaire (HAQ) from baseline to Month 36 Changes in concomitant medication (especially tapering of corticosteroids) from baseline to Months 36 Measure of progressive joint destruction (vdHSS) from baseline of U-Act-Early to Month 24 of U-Act-After Sustained remission rates/drug-free remission rates 36 months Dose modifications/interruptions of RA treatment 36 months Safety: Incidence of adverse events, adverse events of special interest and serious adverse events 36 months
Trial Locations
- Locations (19)
Medisch Centrum Alkmaar
🇳🇱Alkmaar, Netherlands
Meander Medisch Centrum; Locatie Lichtenberg
🇳🇱Amersfoort, Netherlands
Gelre Ziekenhuis Apeldoorn, Lokatie Lukas; Afdeling Interne Geneeskunde
🇳🇱Apeldoorn, Netherlands
Amphia Ziekenhuis
🇳🇱Breda, Netherlands
Rivas Zorggroep, Locatie Beatrixziekenhuis; Reumatologie
🇳🇱Gorinchem, Netherlands
Groene Hart Ziekenhuis
🇳🇱Gouda, Netherlands
Universitair Medisch Centrum Groningen; Department of Rheumatology
🇳🇱Groningen, Netherlands
Kennemer Gasthuis; Inwendige Geneeskunde
🇳🇱Haarlem, Netherlands
Atrium Medisch Centrum; Nephrology
🇳🇱Heerlen, Netherlands
Tergooiziekenhuizen, loc. Hilversum
🇳🇱Hilversum, Netherlands
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