An Observational Study on Long-Term Efficacy and Safety of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis (FAct)

NCT ID: NCT01483326

Last Updated: 2019-05-01

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

215 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-12-31

Study Completion Date

2017-06-19

Brief Summary

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This observational study will evaluate the long-term efficacy and safety of RoActemra/Actemra (tocilizumab in participants of the ACT SURE clinical trial and further patients with moderate to severe rheumatoid arthritis starting or receiving RoActemra/Actemra. Data will be collected from each patient for up to 4 years.

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

* Adult patients, \>18 years of age
* Participants in the ACT-SURE trial, or patients with moderate to severe rheumatoid arthritis starting or receiving RoActemra/Actemra

Exclusion Criteria

* Contra-indications for RoActemra/Actemra
Minimum Eligible Age

18 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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Jan Van Breemen Instituut

Amsterdam, , Netherlands

Site Status

Gelre Ziekenhuis; Reumatology

Apeldoorn, , Netherlands

Site Status

Rijnstate Ziekenhuis; Afdeling Reumatologie

Arnhem, , Netherlands

Site Status

Amphia ziekenhuis, locatie langendijk

Breda, , Netherlands

Site Status

Deventer ziekenhuis

Deventer, , Netherlands

Site Status

MC groep - locatie Emmeloord

Emmeloord, , Netherlands

Site Status

Scheper Ziekenhuis

Emmen, , Netherlands

Site Status

Medisch Centrum Twente; Rheumatology

Enschede, , Netherlands

Site Status

Ziekenhuis Walcheren; Reumatologie

Flushing, , Netherlands

Site Status

Groene Hart Ziekenhuis

Gouda, , Netherlands

Site Status

Röpcke Zweers ziekenhuis; Reumatologie

Hardenberg, , Netherlands

Site Status

Tergooiziekenhuizen, loc. Hilversum

Hilversum, , Netherlands

Site Status

Medisch Centrum Leeuwarden; Reumatology

Leeuwarden, , Netherlands

Site Status

Maastricht University Medical Centre; Rheumatology

Maastricht, , Netherlands

Site Status

St. Antonius Ziekenhuis; Pharmacy

Nieuwegein, , Netherlands

Site Status

St. Maartenskliniek

Nijmegen, , Netherlands

Site Status

Maasstadziekenhuis; Reumatologie

Rotterdam, , Netherlands

Site Status

Vlietland Hospital

Schiedam, , Netherlands

Site Status

Leyenburg Ziekenhuis; Internal Medecine

The Hague, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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ML25411

Identifier Type: -

Identifier Source: org_study_id

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