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)

NCT ID: NCT01918267

Last Updated: 2018-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

226 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-10

Study Completion Date

2017-10-10

Brief Summary

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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

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Conditions

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Rheumatoid Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Medisch Centrum Alkmaar

Alkmaar, , Netherlands

Site Status

Meander Medisch Centrum; Locatie Lichtenberg

Amersfoort, , Netherlands

Site Status

Gelre Ziekenhuis Apeldoorn, Lokatie Lukas; Afdeling Interne Geneeskunde

Apeldoorn, , Netherlands

Site Status

Amphia Ziekenhuis

Breda, , Netherlands

Site Status

Rivas Zorggroep, Locatie Beatrixziekenhuis; Reumatologie

Gorinchem, , Netherlands

Site Status

Groene Hart Ziekenhuis

Gouda, , Netherlands

Site Status

Universitair Medisch Centrum Groningen; Department of Rheumatology

Groningen, , Netherlands

Site Status

Kennemer Gasthuis; Inwendige Geneeskunde

Haarlem, , Netherlands

Site Status

Atrium Medisch Centrum; Nephrology

Heerlen, , Netherlands

Site Status

Tergooiziekenhuizen, loc. Hilversum

Hilversum, , Netherlands

Site Status

Spaarne Ziekenhuis; Inwendige Geneeskunde

Hoofddorp, , Netherlands

Site Status

Medisch Centrum Leeuwarden; Reumatology

Leeuwarden, , Netherlands

Site Status

Academisch Ziekenhuis Leiden; Dept of Rheumatology

Leiden, , Netherlands

Site Status

Ijsselmeer Ziekenhuizen; Interne Geneeskunde

Lelystad, , Netherlands

Site Status

St. Antonius Ziekenhuis Nieuwegein

Nieuwegein, , Netherlands

Site Status

St. Maartenskliniek

Nijmegen, , Netherlands

Site Status

Antonius Ziekenhuis Sneek; Department of Rheumatology

Sneek, , Netherlands

Site Status

University Medical Centre Utrecht; Reumatologie en Klinische Immunologie

Utrecht, , Netherlands

Site Status

Maartenskliniek Woerden

Woerden, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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ML28388

Identifier Type: -

Identifier Source: org_study_id

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