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Contact a representative by phone, email, or visiting the study website. Please see the references below:
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To be included in the study all patients will have received at least 1 dose of Xeljanz for the treatment of the following indication as per local labelling. Moderately to severely active RA in adult patients who have had an inadequate response or intolerance to previous therapy with at least 1 biological DMARD. Or Active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to previous antirheumatic drugs (DMARDs)
1. Patients with a history of hypersensitivity to any ingredients of the product.
2. Patients with serious infection (eg, sepsis) or active infection including localized
infection.
3. Patients with active tuberculosis.
4. Patients with severe hepatic function disorder.
5. Patients with an absolute neutrophil count (ANC) <500 cells/mm3.
6. Patients with a lymphocyte count <500 cells/mm3.
7. Patients with a hemoglobin concentration <8 g/dL.
8. Pregnant or possibly pregnant women.
9. Because of lactose contained in this drug, it should not be administered to patients
with hereditary problems of galactose intolerance, Lapp lactase deficiency or
glucose-galactose malabsorption.
According to Contraindication on label, the investigator should discontinue the patient's
treatment if the laboratory test results are as below Patients with an absolute neutrophil
count (ANC) <500 cells/mm3 Patients with a hemoglobin level <8 g/dL
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Descriptive Information | |||||
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Brief Title | Korean Post-marketing Surveillance for Xeljanz | ||||
Official Title | Korean Post-marketing Surveillance for Xeljanz(REGISTERED) in Rheumatoid Arthritis and Psoriatic Arthritis Patients | ||||
Brief Summary | The objective of this study is to identify any problems and questions with respect to the safety and efficacy of Xeljanz during the post-marketing period as required by the regulation of MFDS. | ||||
Detailed Description | Not Provided | ||||
Study Type | Observational | ||||
Study Design | Observational Model: Case-Only Time Perspective: Prospective | ||||
Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Non-Probability Sample | ||||
Study Population | adult rheumatoid arthritis or psoriatic arthritis taking tofacitinib within label as Ministry of Food and Drung Safety in Korea has approved | ||||
Condition |
| ||||
Intervention | Not Provided | ||||
Study Groups/Cohorts | Not Provided | ||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
Recruitment Information | |||||
Recruitment Status | Recruiting | ||||
Estimated Enrollment | 1000 | ||||
Original Estimated Enrollment | 3000 | ||||
Estimated Study Completion Date | June 1, 2022 | ||||
Estimated Primary Completion Date | April 1, 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Inclusion Criteria: To be included in the study all patients will have received at least 1 dose of Xeljanz for the treatment of the following indication as per local labelling. Moderately to severely active RA in adult patients who have had an inadequate response or intolerance to previous therapy with at least 1 biological DMARD. Or Active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to previous antirheumatic drugs (DMARDs) Exclusion Criteria:
According to Contraindication on label, the investigator should discontinue the patient's treatment if the laboratory test results are as below Patients with an absolute neutrophil count (ANC) <500 cells/mm3 Patients with a hemoglobin level <8 g/dL | ||||
Sex/Gender |
| ||||
Ages | 19 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts |
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Listed Location Countries | Korea, Republic of | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT02984020 | ||||
Other Study ID Numbers | A3921249 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement |
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Responsible Party | Pfizer | ||||
Study Sponsor | Pfizer | ||||
Collaborators | Not Provided | ||||
Investigators |
| ||||
PRS Account | Pfizer | ||||
Verification Date | December 2020 |