Korean Post-marketing Surveillance for Xeljanz

NCT02984020

Last updated date
Study Location
Chonbuk National University Hospital, Department of Rheumatology
Chonju, Chonbuk, 561-712, Korea, Republic of
Contact
1-800-718-1021

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis, Psoriatic Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
19 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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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Rheumatoid Arthritis, Psoriatic ArthritisKorean Post-marketing Surveillance for Xeljanz
NCT02984020
  1. Chonju, Chonbuk
  2. Cheonan, Chung NAM
  3. Chunan-si, Chungcheongnam-do
  4. Jung-Gu, Daegu
  5. Seo-gu, Daejon
  6. Seoul, Gangdong-gu
  7. Seoul, Gangdong-gu
  8. Dong Gu, Gwang JU
  9. Seongnam-si, Gyeongg-do
  10. Seongnam-si, Gyeonggi-do
  11. Yangsan-si, Gyeongsangnam-do
  12. Yangsan-si, Gyeongsangnam-do
  13. Iksan, Jeonlabuk-do
  14. Suwon-si, Kyeongki-do
  15. Ansan, Gyeonggi-do,
  16. Busan,
  17. Busan,
  18. Busan,
  19. Chungcheongbuk-do,
  20. Daegu,
  21. Daejeon,
  22. Goyang-si, Gyeonggi-do,
  23. Gyeonggi-do,
  24. Incheon,
  25. Incheon,
  26. Jeju Special Self-Goverming Province,
  27. Metropolitan City, Daejeon,
  28. Pusan,
  29. Pusan,
  30. Seoul,
  31. Seoul,
  32. Seoul,
  33. Seoul,
  34. Seoul,
  35. Seoul,
  36. Seoul,
  37. Seoul,
  38. Seoul,
  39. Seoul,
  40. Seoul,
  41. Seoul,
  42. Seoul,
  43. Seoul,
  44. Seoul,
  45. Seoul,
  46. Seoul,
ALL GENDERS
19 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Korean Post-marketing Surveillance for Xeljanz
Official Title KOREAN POST-MARKETING SURVEILLANCE FOR XELJANZ (REGISTERED)
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
  • Rheumatoid Arthritis
  • Psoriatic Arthritis
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
 (submitted: May 20, 2020)
700
Original Estimated Enrollment
 (submitted: December 2, 2016)
3000
Estimated Study Completion Date June 9, 2020
Estimated Primary Completion Date June 9, 2020   (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:

  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

Sex/Gender
Sexes Eligible for Study:All
Ages 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
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
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date May 2020