Tofacitinib (Xeljanz) Special Investigation for Rheumatoid Arthritis
NCT ID: NCT01932372
Last Updated: 2024-10-26
Study Results
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View full resultsBasic Information
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COMPLETED
9968 participants
OBSERVATIONAL
2013-07-26
2021-08-24
Brief Summary
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1\) Occurrence of adverse reactions, factors that may potentially affect safety and efficacy 2） Long-term safety (particularly, malignant tumors and serious infections) and efficacy
Occurrences of malignant tumors and serious infections will be compared with a control group.
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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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Tofacitinib (Xeljanz)
Tablets 5 mg BID
Tofacitinib (Xeljanz)
5 mg Tablet BID
Standard of Care
Standard of Care for Rheumatoid Arthritis
Etanercept, other Biologics, Disease-modifying antirheumatic drugs (DMARDs), etc
Etanercept: 10 to 25 mg twice weekly, or 25 to 50 mg once weekly
Interventions
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Tofacitinib (Xeljanz)
5 mg Tablet BID
Etanercept, other Biologics, Disease-modifying antirheumatic drugs (DMARDs), etc
Etanercept: 10 to 25 mg twice weekly, or 25 to 50 mg once weekly
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
0 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Tokyo, , Japan
Countries
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References
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Kuwana M, Sugiyama N, Momohara S, Atsumi T, Takei S, Tamura N, Harigai M, Fujii T, Matsuno H, Takeuchi T, Yamamoto K, Takasaki Y, Tanigawa M, Endo Y, Hirose T, Morishima Y, Yoshii N, Mimori T, Takagi M. Six-month safety and effectiveness of tofacitinib in patients with rheumatoid arthritis in Japan: Interim analysis of post-marketing surveillance. Mod Rheumatol. 2024 Feb 26;34(2):272-286. doi: 10.1093/mr/road063.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A3921194
Identifier Type: -
Identifier Source: org_study_id
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