An Observational Study in Rheumatoid Arthritis Patients Treated With RoActemra/Actemra (Tocilizumab)

NCT ID: NCT01565122

Last Updated: 2016-11-02

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

51 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-31

Study Completion Date

2014-05-31

Brief Summary

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This multi-center, observational study will evaluate the clinical practice patterns, efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Data will be collected from each eligible patient initiated on RoActemra/Actemra treatment by their treating physician according to approved label for up to 12 months from start of treatment.

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
* Moderate to severe rheumatoid arthritis
* Patients for whom the treating physician has made the decision to commence RoActemra/Actemra treatment. In Group A RoActemra/Actemra has been prescribed within 8 weeks prior to the enrolment visit. In Group B RoActemra/Actemra has been started more than 8 weeks before inclusion in the study, but not before January 2011

Exclusion Criteria

* RoActemra/Actemra treatment more than 8 weeks prior to inclusion visit for Group A, before January 2011 for Group B
* Previous RoActemra/Actemra treatment in a clinical trial or for compassionate use
* Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra
* History of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis
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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Helsinki, , Finland

Site Status

Joensuu, , Finland

Site Status

Jyväskylä, , Finland

Site Status

Kuopio, , Finland

Site Status

Lahti, , Finland

Site Status

Paimio, , Finland

Site Status

Riihimäki, , Finland

Site Status

Rovaniemi, , Finland

Site Status

Tampere, , Finland

Site Status

Vaasa, , Finland

Site Status

Countries

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Finland

Other Identifiers

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ML28207

Identifier Type: -

Identifier Source: org_study_id