A Non-Interventional Study of Rheumatoid Arthritis Patients Treated With RoActemra/Actemra (Tocilizumab) in Monotherapy
NCT ID: NCT01705730
Last Updated: 2018-09-04
Study Results
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View full resultsBasic Information
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COMPLETED
71 participants
OBSERVATIONAL
2012-07-31
2014-12-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Tocilizumab
Participants with rheumatoid arthritis (RA) received tocilizumab monotherapy according to individualized physician-prescribed regimens.
tocilizumab
Participants received tocilizumab monotherapy according to individualized physician-prescribed regimens.
Interventions
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tocilizumab
Participants received tocilizumab monotherapy according to individualized physician-prescribed regimens.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Moderate to severe rheumatoid arthritis according to the revised (1987) ACR criteria
* Participants in whom the treating physician has made the decision to commence RoActemra/Actemra treatment in monotherapy in accordance with the local label and the reimbursement criteria indicating that RoActemra/Actemra can be given in monotherapy in case of methotrexate intolerance or where continued treatment with methotrexate is inappropriate; this can include participants who have received RoActemra/Actemra treatment within 8 weeks prior to the enrolment visit
* Concomitant treatment with NSAIDs and/or corticosteroids is allowed
Exclusion Criteria
* Participants who have previously received RoActemra/Actemra in a clinical trial or for compassionate use
* Participants receiving concomitant DMARD treatment for rheumatoid arthritis at baseline (e.g. hydroxychloroquine, sulfasalazine, methotrexate, leflunomide, gold compounds, cyclosporine) will be excluded from the study
* Participants 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
* Participants with a history of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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ASZ Aalst
Aalst, , Belgium
CH EpiCURA Site Ath
Ath, , Belgium
CHU Brugmann (Victor Horta)
Brussels, , Belgium
Hospital Erasme; Neurologie
Brussels, , Belgium
Reumaclinic
Genk, , Belgium
GHdC Site Saint-Joseph
Gilly (Charleroi), , Belgium
Clinique Notre Dame de Grâce
Gosselies, , Belgium
CH Jolimont - Lobbes (Jolimont)
Haine-Saint-Paul, , Belgium
AZ Groeninge
Kortrijk, , Belgium
Chr de La Citadelle
Liège, , Belgium
Clinique Saint-Joseph
Liège, , Belgium
CHU Ambroise Paré
Mons, , Belgium
AZ Damiaan
Ostend, , Belgium
Clinique St Pierre asbl
Ottignies, , Belgium
AZ Delta (Campus Wilgenstraat)
Roeselare, , Belgium
AZ Turnhout Sint Jozef
Turnhout, , Belgium
Sint Augustinus Wilrijk
Wilrijk, , Belgium
Countries
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Other Identifiers
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ML28269
Identifier Type: -
Identifier Source: org_study_id
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