A Study of Tocilizumab in Participants With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Non-Biological Disease-modifying Anti-rheumatic Drugs (DMARDs)
NCT ID: NCT01617005
Last Updated: 2016-12-01
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
50 participants
OBSERVATIONAL
2012-05-31
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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Tocilizumab in Moderate to Severe Active RA
Moderate to severe active RA participants, receiving tocilizumab treatment according to effective official Summary of Product Characteristics (SPC), will be observed. The choice of therapy will be based exclusively on the medical decision of the treating physician before study enrollment. The study protocol does not enforce treatment initiation and also does not specify any treatment regimen.
Tocilizumab
Participants will receive tocilizumab treatment according to effective official SPC. The study protocol does not enforce treatment initiation and also does not specify any treatment regimen.
Interventions
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Tocilizumab
Participants will receive tocilizumab treatment according to effective official SPC. The study protocol does not enforce treatment initiation and also does not specify any treatment regimen.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Inadequate response to DMARDs or tumor necrosis factor (TNF) antagonists
* Initiating treatment with tocilizumab according to SPC
Exclusion Criteria
* Prior history or current inflammatory joint disease other than RA
* Previous treatment with any biological drug used in the treatment of RA
* Previous treatment with tocilizumab
* Any contraindication to treatment with tocilizumab
* Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following enrollment
* Pregnant women or nursing (breastfeeding) mothers
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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Podgorica, , Montenegro
Countries
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Other Identifiers
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ML25699
Identifier Type: -
Identifier Source: org_study_id