The objective of this Surveillance is to verify the following subject matters concerning
Tofacitinib (Xeljanz) under general practice.
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.
- All patients receiving Tofacitinib (Xeljanz)
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | Tofacitinib (Xeljanz) Special Investigation for Rheumatoid Arthritis | |||
| Official Title | Tofacitinib Special Investigation Of Xeljanz Tablets 5mg. (Regulatory Post Marketing Commitment Plan) | |||
| Brief Summary |
The objective of this Surveillance is to verify the following subject matters concerning Tofacitinib (Xeljanz) under general practice. 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 | All the patients whom an investigator prescribes the Xeljanz or Standard of Care for rheumatoid arthritis should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random. | |||
| Study Type | Observational | |||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Probability Sample | |||
| Study Population | Adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to over 8 mg Methotrexate for 3 months treatment. | |||
| Condition | Rheumatoid Arthritis | |||
| Intervention |
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| Study Groups/Cohorts |
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| Publications * | Not Provided | |||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||
| Recruitment Status | Active, not recruiting | |||
| Enrollment | 6000 | |||
| Estimated Completion Date | January 26, 2021 | |||
| Estimated Primary Completion Date | January 26, 2021 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria: |
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| Sex/Gender |
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| Ages | Child, Adult, Senior | |||
| Accepts Healthy Volunteers | No | |||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries | Not Provided | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number | NCT01932372 | |||
| Other Study ID Numbers | A3921194 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor | Pfizer | |||
| Collaborators | Not Provided | |||
| Investigators |
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| PRS Account | Pfizer | |||
| Verification Date | December 2017 | |||
Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.
Pfizer Clinical Trials Contact Center
1-800-718-1021
