An Observational Study on the Safety and Effectiveness of Rituximab in Patients With Severe Active Rheumatoid Arthritis
NCT ID: NCT01071798
Last Updated: 2016-02-22
Study Results
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View full resultsBasic Information
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COMPLETED
1653 participants
OBSERVATIONAL
2010-01-31
2014-10-31
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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Main Analysis Set
Participants who received at least one cycle of rituximab
Rituximab
As prescribed by physician
Interventions
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Rituximab
As prescribed by physician
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 18 years or older
* Patients with active, severe rheumatoid arthritis with prescription of rituximab according to German Summary of Product Characteristics (SmPC - "Fachinformation")
* Patients with signed informed consent
* Female patients with secure contraception
Exclusion Criteria
1. Active severe infection
2. Severe heart failure (NYHA class IV) or severe, uncontrollable heart disease
3. Participation in an interventional study within the last 3 months before therapy start with rituximab
4. Pretreatment with rituximab
5. Age \<18 years
6. Known intolerability of monoclonal antibodies or chimeric monoclonal antibodies
7. Known pregnancy or breastfeeding
* Data of patients without approval of data by the physician
* Patients without informed consent
* Double documentation
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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Berlin, , Germany
Countries
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References
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Tony HP, Roll P, Mei HE, Blumner E, Straka A, Gnuegge L, Dorner T; FIRST/ ReFIRST study teams. Combination of B cell biomarkers as independent predictors of response in patients with rheumatoid arthritis treated with rituximab. Clin Exp Rheumatol. 2015 Nov-Dec;33(6):887-94. Epub 2015 Oct 30.
Other Identifiers
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ML22639
Identifier Type: -
Identifier Source: org_study_id
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