A Non-interventional Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis

NCT ID: NCT01562327

Last Updated: 2016-11-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-02-29

Study Completion Date

2014-03-31

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 participants with moderate to severe rheumatoid arthritis. Data will be collected from each eligible participant initiated on RoActemra/Actemra treatment by their treating physician according to local label for 6 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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Tocilizumab

Participants with moderate to severe rheumatoid arthritis (RA) received Tocilizumab according to individualized physician-prescribed regimens.

Tocilizumab

Intervention Type DRUG

Participants received tocilizumab according to individualized physician-prescribed regimens.

Interventions

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Tocilizumab

Participants received tocilizumab according to individualized physician-prescribed regimens.

Intervention Type DRUG

Other Intervention Names

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Actemra

Eligibility Criteria

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Inclusion Criteria

* Adult participants, \>/= 18 years of age
* Moderate to severe rheumatoid arthritis
* Participants initiating treatment with RoActemra/Actemra on their physician's decision (in accordance with the local label), including participants who started treatment with RoActemra/Actemra in the 8 weeks prior to the enrolment visit

Exclusion Criteria

* RoActemra/Actemra treatment more than 8 weeks prior to the enrolment visit
* 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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Buenos Aires, , Argentina

Site Status

Buenos Aires, , Argentina

Site Status

Ciudad Autonoma de, , Argentina

Site Status

La Plata, , Argentina

Site Status

San Juan, , Argentina

Site Status

San Juan Bautista, , Argentina

Site Status

San Miguel de Tucumán, , Argentina

Site Status

Countries

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Argentina

Other Identifiers

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ML28142

Identifier Type: -

Identifier Source: org_study_id