A Non-Interventional Study in Patients With Rheumatoid Arthritis Who Are Treated With RoActemra/Actemra (Tocilizumab)

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

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-30

Study Completion Date

2014-06-30

Brief Summary

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This observational study will evaluate the use and efficacy of RoActemra/Actemra (tocilizumab) in monotherapy in routine clinical practice 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 (1987) ACR criteria
* Patients in whom the treating physician has made the decision to commence RoActemra/Actemra treatment in accordance with the local label; this can include patients who have received RoActemra/Actemra treatment within 8 weeks prior to the enrolment visit
* Patients who for any reason do not take methotrexate and the treating physician has made a decision to prescribe RoActemra/Actemra as monotherapy
* Patients who were previously on a TNF inhibitor as monotherapy, and the treating physician has made a decision to prescribe RoActemra/Actemra as monotherapy
* Concomitant treatment with corticosteroids (orally and intra-articularly) and/or NSAIDs is allowed

Exclusion Criteria

* Patients who have received RoActemra/Actemra more than 8 weeks prior to the enrolment visit
* Patients who have previously received RoActemra/Actemra in a clinical trial or for compassionate use
* Patients receiving concomitant DMARD treatment for rheumatoid arthritis (e.g. hydroxychloroquine, sulfasalazine, methotrexate, leflunomide, gold compounds, cyclosporine)
* Patients who have received treatment with an investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra
* Patients with a 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

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Countries

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Morocco

Other Identifiers

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ML28443

Identifier Type: -

Identifier Source: org_study_id