An Observational Study of MabThera/Rituxan (Rituximab) in Patients With Rheumatoid Arthritis and an Inadequate Response or Intolerance to One Anti-Tumor Necrosis Factor (Anti-TNF) Agent
NCT ID: NCT01641952
Last Updated: 2016-08-17
Study Results
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View full resultsBasic Information
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COMPLETED
505 participants
OBSERVATIONAL
2011-10-31
2015-01-31
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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Rituximab
Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
Rituximab
Rituximab at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
Interventions
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Rituximab
Rituximab at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants with rheumatoid arthritis, eligible for treatment with MabThera/Rituxan in accordance with summary of product characteristics (SPC)
* Inadequate response to a single TNF inhibitor defined as change in disease activity score-28 erythrocyte sedimentation rate (DAS28-ESR) \<1.2 or DAS28-ESR \>3.5 at 5 months after first course of anti-TNF therapy
* Participants with a clinical and biological evaluation performed within 12 weeks prior to enrollment may be included
Exclusion Criteria
* Any other biological therapy apart from the one anti-TNF therapy
* Hypersensitivity to rituximab or any of the excipients or to murine proteins
* Active severe infections
* Participants in a severely immunocompromised state
* Severe heart failure \[New York Heart Association (NYHA) Class IV\] or severe, uncontrolled cardiac disease
* Women of childbearing potential not willing to use contraception
* Pregnant or breastfeeding women
* Participation in another trial
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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Bucharest, , Romania
Countries
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Other Identifiers
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ML27953
Identifier Type: -
Identifier Source: org_study_id
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