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)

Rheumatoid Arthritis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01918267
• Other study ID #: ML28388
• Status: Completed
• Start date: April 10, 2012
• Est. completion date: October 10, 2017

Study information

• Verified date: May 2018
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 226
• Est. completion date: October 10, 2017
• Est. primary completion date: October 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
Netherlands	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	Spaarne Ziekenhuis; Inwendige Geneeskunde	Hoofddorp
Netherlands	Medisch Centrum Leeuwarden; Reumatology	Leeuwarden
Netherlands	Academisch Ziekenhuis Leiden; Dept of Rheumatology	Leiden
Netherlands	Ijsselmeer Ziekenhuizen; Interne Geneeskunde	Lelystad
Netherlands	St. Antonius Ziekenhuis Nieuwegein	Nieuwegein
Netherlands	St. Maartenskliniek	Nijmegen
Netherlands	Antonius Ziekenhuis Sneek; Department of Rheumatology	Sneek
Netherlands	University Medical Centre Utrecht; Reumatologie en Klinische Immunologie	Utrecht
Netherlands	Maartenskliniek Woerden	Woerden

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Disease Activity Score (DAS28)		from baseline to Month 36
Secondary	Change in disability, assessed by the Dutch consensus Health Assessment Questionnaire (HAQ)		from baseline to Month 36
Secondary	Measure of progressive joint destruction (vdHSS)		from baseline of U-Act-Early to Month 24 of U-Act-After
Secondary	Changes in concomitant medication (especially tapering of corticosteroids)		from baseline to Months 36
Secondary	Sustained remission rates/drug-free remission rates		36 months
Secondary	Dose modifications/interruptions of RA treatment		36 months
Secondary	Safety: Incidence of adverse events, adverse events of special interest and serious adverse events		36 months