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)

May 10, 2018 updated by: Hoffmann-La Roche
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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

226

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Alkmaar, Netherlands, 1815 JD
        • Medisch Centrum Alkmaar
      • Amersfoort, Netherlands, 3818 ES
        • Meander Medisch Centrum; Locatie Lichtenberg
      • Apeldoorn, Netherlands, 7334 DZ
        • Gelre Ziekenhuis Apeldoorn, Lokatie Lukas; Afdeling Interne Geneeskunde
      • Breda, Netherlands, 4819 EV
        • Amphia Ziekenhuis
      • Gorinchem, Netherlands, 4204 AA
        • Rivas Zorggroep, Locatie Beatrixziekenhuis; Reumatologie
      • Gouda, Netherlands, 2803 HH
        • Groene Hart Ziekenhuis
      • Groningen, Netherlands, 9700RB
        • Universitair Medisch Centrum Groningen; Department of Rheumatology
      • Haarlem, Netherlands, 2035RC
        • Kennemer Gasthuis; Inwendige Geneeskunde
      • Heerlen, Netherlands, 6419 PC
        • Atrium Medisch Centrum; Nephrology
      • Hilversum, Netherlands, 1213 HX
        • Tergooiziekenhuizen, loc. Hilversum
      • Hoofddorp, Netherlands, 2134 TM
        • Spaarne Ziekenhuis; Inwendige Geneeskunde
      • Leeuwarden, Netherlands, 8934 AD
        • Medisch Centrum Leeuwarden; Reumatology
      • Leiden, Netherlands, 2333 ZA
        • Academisch Ziekenhuis Leiden; Dept of Rheumatology
      • Lelystad, Netherlands, 8233 AA
        • Ijsselmeer Ziekenhuizen; Interne Geneeskunde
      • Nieuwegein, Netherlands, 3430 EM
        • St. Antonius Ziekenhuis Nieuwegein
      • Nijmegen, Netherlands, 6522 JV
        • St. Maartenskliniek
      • Sneek, Netherlands, 8601 ZK
        • Antonius Ziekenhuis Sneek; Department of Rheumatology
      • Utrecht, Netherlands, 3584 GA
        • University Medical Centre Utrecht; Reumatologie en Klinische Immunologie
      • Woerden, Netherlands, 3447 GN
        • Maartenskliniek Woerden

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who participated in the U Act Early study (ML22497)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Disease Activity Score (DAS28)
Time Frame: from baseline to Month 36
from baseline to Month 36

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in disability, assessed by the Dutch consensus Health Assessment Questionnaire (HAQ)
Time Frame: from baseline to Month 36
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
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
from baseline to Months 36
Sustained remission rates/drug-free remission rates
Time Frame: 36 months
36 months
Dose modifications/interruptions of RA treatment
Time Frame: 36 months
36 months
Safety: Incidence of adverse events, adverse events of special interest and serious adverse events
Time Frame: 36 months
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 10, 2012

Primary Completion (ACTUAL)

October 10, 2017

Study Completion (ACTUAL)

October 10, 2017

Study Registration Dates

First Submitted

August 6, 2013

First Submitted That Met QC Criteria

August 6, 2013

First Posted (ESTIMATE)

August 7, 2013

Study Record Updates

Last Update Posted (ACTUAL)

May 11, 2018

Last Update Submitted That Met QC Criteria

May 10, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML28388

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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