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)

Completed

• 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

Study Timeline

• Study Start: 2012-04-10
• Study First Submitted: 2013-08-06
• Study First Submitted QC: 2013-08-06
• Study First Posted: 2013-08-07
• Primary Completion: 2017-10-10
• Study Completion: 2017-10-10
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-10
• Last Update Posted: 2018-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 226

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

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)

St. Antonius Ziekenhuis Nieuwegein; 🇳🇱 Nieuwegein, Netherlands

University Medical Centre Utrecht; Reumatologie en Klinische Immunologie; 🇳🇱 Utrecht, Netherlands

Maartenskliniek Woerden; 🇳🇱 Woerden, Netherlands

Medisch Centrum Alkmaar; 🇳🇱 Alkmaar, Netherlands

Gelre Ziekenhuis Apeldoorn, Lokatie Lukas; Afdeling Interne Geneeskunde; 🇳🇱 Apeldoorn, Netherlands

Kennemer Gasthuis; Inwendige Geneeskunde; 🇳🇱 Haarlem, Netherlands

Spaarne Ziekenhuis; Inwendige Geneeskunde; 🇳🇱 Hoofddorp, Netherlands

Ijsselmeer Ziekenhuizen; Interne Geneeskunde; 🇳🇱 Lelystad, Netherlands

Meander Medisch Centrum; Locatie Lichtenberg; 🇳🇱 Amersfoort, Netherlands

Groene Hart Ziekenhuis; 🇳🇱 Gouda, Netherlands

Universitair Medisch Centrum Groningen; Department of Rheumatology; 🇳🇱 Groningen, Netherlands

Atrium Medisch Centrum; Nephrology; 🇳🇱 Heerlen, Netherlands

Academisch Ziekenhuis Leiden; Dept of Rheumatology; 🇳🇱 Leiden, Netherlands

St. Maartenskliniek; 🇳🇱 Nijmegen, Netherlands

Antonius Ziekenhuis Sneek; Department of Rheumatology; 🇳🇱 Sneek, Netherlands

Amphia Ziekenhuis; 🇳🇱 Breda, Netherlands

Rivas Zorggroep, Locatie Beatrixziekenhuis; Reumatologie; 🇳🇱 Gorinchem, Netherlands

Tergooiziekenhuizen, loc. Hilversum; 🇳🇱 Hilversum, Netherlands

Medisch Centrum Leeuwarden; Reumatology; 🇳🇱 Leeuwarden, Netherlands