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A Retrospective, Observational Study of RoActemra/Actemra (Tocilizumab) in Clinical Practice in Patients With Rheumatoid Arthritis

NCT ID: NCT01921478

Last Updated: 2013-08-13

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

77 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-08-31

Study Completion Date

2010-11-30

Brief Summary

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This retrospective, multi-centre, observational study will assess the daily practice patterns and outcomes of the management of rheumatoid arthritis in patients treated with RoActemra/Actemra (tocilizumab). No actual patient will be enrolled in this study; data will be collected from medical records.

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

RETROSPECTIVE

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
* Diagnosed with rheumatoid arthritis and moderate to severe disease activity defined as a DAS28 \>=5.1
* Inadequate responder to at least 2 non-biological DMARDs
* Absence of documented erosions at start of RoActemra/Actemra treatment
* Received RoActemra/Actemra treatment for at least 6 months
* Availability of data from at least the RoActemra/Actemra treatment initiation visit and the 6 months visit

Exclusion Criteria

* Contraindications for treatment with 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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Aalst, , Belgium

Site Status

Antwerp, , Belgium

Site Status

Bruges, , Belgium

Site Status

Brussels, , Belgium

Site Status

Ghent, , Belgium

Site Status

Gilly, , Belgium

Site Status

Seraing, , Belgium

Site Status

Verviers, , Belgium

Site Status

Westmalle, , Belgium

Site Status

Wilrijk, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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ML25271

Identifier Type: -

Identifier Source: org_study_id