An Observational Study of RoActemra/Actemra (Tocilizumab) in Monotherapy in Patients With Rheumatoid Arthritis
NCT ID: NCT01669902
Last Updated: 2015-11-23
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
107 participants
OBSERVATIONAL
2012-04-30
2014-09-30
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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Cohort
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Moderate to severe rheumatoid arthritis according to the revised (1987) ACR criteria
* Patients who for any reason do not take methotrexate and for whom the treating physician has made a decision to prescribe RoActemra/Actemra as monotherapy; patients who commenced RoActemra/Actemra as monotherapy within 8 weeks prior to the enrolment visit may be included
* Concomitant treatment with non-steroidal anti-inflammatory drug (NSAID) or corticosteroids (orally or intra-articularly) is allowed
Exclusion Criteria
* Previous RoActemra/Actemra treatment in a clinical trial or for compassionate use
* Concomitant DMARD treatment for rheumatoid arthritis (e.g. hyroxychloroquine, sulfasalazine, methotrexate, leflunomide, gold compounds, cyclosporine)
* Treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational agent, whichever is longer) before starting RoActemra/Actemra treatment
* 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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Esbjerg, , Denmark
Holbæk, , Denmark
Kolding, , Denmark
Køge, , Denmark
Svendborg, , Denmark
Vejle, , Denmark
Bergen, , Norway
Gjettum, , Norway
Moss, , Norway
Skien, , Norway
Trondheim, , Norway
Falun, , Sweden
Farsta, , Sweden
Gothenburg, , Sweden
Helsingborg, , Sweden
Hudiksvall, , Sweden
Jönköping, , Sweden
Karlskrona, , Sweden
Karlstad, , Sweden
Kristianstad, , Sweden
Malmo, , Sweden
Simrishamn, , Sweden
Skövde, , Sweden
Trelleborg, , Sweden
Uppsala, , Sweden
Västerås, , Sweden
Countries
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Other Identifiers
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ML28247
Identifier Type: -
Identifier Source: org_study_id