Clinical trial NCT01918267: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-08-07
Enrollment: 226
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who participated in the U Act Early study (ML22497)

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Disease Activity Score (DAS28)
timeFrame: from baseline to Month 36
Secondary outcomes:
measure: Change in disability, assessed by the Dutch consensus Health Assessment Questionnaire (HAQ)
timeFrame: from baseline to Month 36
measure: Measure of progressive joint destruction (vdHSS)
timeFrame: from baseline of U-Act-Early to Month 24 of U-Act-After
measure: Changes in concomitant medication (especially tapering of corticosteroids)
timeFrame: from baseline to Months 36
measure: Sustained remission rates/drug-free remission rates
timeFrame: 36 months
measure: Dose modifications/interruptions of RA treatment
timeFrame: 36 months
measure: Safety: Incidence of adverse events, adverse events of special interest and serious adverse events
timeFrame: 36 months
Other outcomes:
Locations:
city: Alkmaar
country: Netherlands
facility: Medisch Centrum Alkmaar
city: Amersfoort
country: Netherlands
facility: Meander Medisch Centrum; Locatie Lichtenberg
city: Apeldoorn
country: Netherlands
facility: Gelre Ziekenhuis Apeldoorn, Lokatie Lukas; Afdeling Interne Geneeskunde
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
city: Gorinchem
country: Netherlands
facility: Rivas Zorggroep, Locatie Beatrixziekenhuis; Reumatologie
city: Gouda
country: Netherlands
facility: Groene Hart Ziekenhuis
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen; Department of Rheumatology
city: Haarlem
country: Netherlands
facility: Kennemer Gasthuis; Inwendige Geneeskunde
city: Heerlen
country: Netherlands
facility: Atrium Medisch Centrum; Nephrology
city: Hilversum
country: Netherlands
facility: Tergooiziekenhuizen, loc. Hilversum
city: Hoofddorp
country: Netherlands
facility: Spaarne Ziekenhuis; Inwendige Geneeskunde
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden; Reumatology
city: Leiden
country: Netherlands
facility: Academisch Ziekenhuis Leiden; Dept of Rheumatology
city: Lelystad
country: Netherlands
facility: Ijsselmeer Ziekenhuizen; Interne Geneeskunde
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis Nieuwegein
city: Nijmegen
country: Netherlands
facility: St. Maartenskliniek
city: Sneek
country: Netherlands
facility: Antonius Ziekenhuis Sneek; Department of Rheumatology
city: Utrecht
country: Netherlands
facility: University Medical Centre Utrecht; Reumatologie en Klinische Immunologie
city: Woerden
country: Netherlands
facility: Maartenskliniek Woerden
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: