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

NCT ID: NCT01615419

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

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-31

Study Completion Date

2013-11-30

Brief Summary

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This multi-center, observational study will evaluate the use in clinical practice and efficacy of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Eligible patients initiated on RoActemra/Actemra treatment according to the approved label will be followed for 6 months.

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 , according to the revised ACR criteria
* Patients initiated on RoActemra/Actemra treatment (in accordance with the local label) on their treating physicians decision

Exclusion Criteria

* RoActemra/Actemra treatment more than 8 weeks prior to 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 investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra
* History of autoimmune disease or of any joint inflammatory disease other than RA
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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Athens, , Greece

Site Status

Athens, , Greece

Site Status

Athens, , Greece

Site Status

Larissa, , Greece

Site Status

Pátrai, , Greece

Site Status

Pátrai, , Greece

Site Status

Rhodes, , Greece

Site Status

Thessaloniki, , Greece

Site Status

Thessaloniki, , Greece

Site Status

Countries

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Greece

Other Identifiers

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ML28259

Identifier Type: -

Identifier Source: org_study_id