A Prospective, Non-Interventional Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Active Rheumatoid Arthritis

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

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-04-18

Study Completion Date

2017-01-25

Brief Summary

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This prospective, observational study will evaluate the efficacy, safety and tolerability of RoActemra/Actemra (tocilizumab) in patients with moderate to severe active rheumatoid arthritis who have had an inadequate response or are intolerant to one or more conventional disease-modifying anti-rheumatic drugs. Data will be collected from patients initiated on RoActemra/Actemra treatment according to the local label at baseline, Weeks 4, 12 and 24, and at 3 and 6 months after the last dose of study drug.

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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, \>/= 21 years of age
* Moderate to severe active rheumatoid arthritis (DAS28 \>/= 3.2)
* Inadequate response to one or more conventional disease-modifying anti-rheumatic drugs (DMARDs)
* Initiated on RoActemra/Actemra treatment in accordance with the prescribing information

Exclusion Criteria

* Pregnant or lactating women
* Contra-indication to RoActemra/Actemra treatment according to the local labelling
* Previous treatment with tocilizumab
* 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
* Women of childbearing potential not using effective methods of contraception as defined by protocol

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No