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)

N/ACompletedNCT01918267

Hoffmann-La Roche226 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

226

Conditions

Rheumatoid Arthritis

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Criteria: * 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

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

...and 9 more locations

Outcomes

Primary Outcomes

Change in Disease Activity Score (DAS28)

Time frame: from baseline to Month 36

Secondary Outcomes

Change in disability, assessed by the Dutch consensus Health Assessment Questionnaire (HAQ)

Time frame: from baseline to Month 36

Measure of progressive joint destruction (vdHSS)

Time frame: from baseline of U-Act-Early to Month 24 of U-Act-After

Changes in concomitant medication (especially tapering of corticosteroids)

Time frame: from baseline to Months 36

Sustained remission rates/drug-free remission rates

Time frame: 36 months

Dose modifications/interruptions of RA treatment

Time frame: 36 months

Safety: Incidence of adverse events, adverse events of special interest and serious adverse events

Time frame: 36 months