Korean Post-marketing Surveillance for Xeljanz XR

NCT04876781

Last updated date
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1-800-718-1021

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

1. Moderately to severely active RA in adult patients who have had an inadequate response or intolerance to methotrexate.

2. Patients who have previously been given Xeljanz 5mg, who have changed Xeljanz XR, are also eligible for registration in the study.

3. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

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


Patients meeting any of the following criteria will not be included in the study:


1. Patients with a history of hypersensitivity to any ingredients of this product.


2. Patients with serious infection (sepsis, etc.) 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) <1,000 cells/mm3. *


6. Patients with a lymphocyte count <500 cells/mm3. *


7. Patients with a hemoglobin level <9 g/dL. *


8. Pregnant or possibly pregnant women. * Do not initiate Xeljanz XR in the following
cases: ANC; absolute neutrophil count <1,000 cells/mm3 ALC; absolute lymphocyte count
<500 cells/mm3 Hemoglobin<9 g/dL

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Active Moderate to Severe Rheumatoid ArthritisKorean Post-marketing Surveillance for Xeljanz XR
NCT04876781
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Korean Post-marketing Surveillance for Xeljanz XR
Official Title Korean Post-marketing Surveillance for Xeljanz XR (Registered)
Brief Summary

Xeljanz(tofacitinib) is a potent, oral janus kinase inhibitor. Xeljanz Tab 5mg was approved by MFDS in 2014 for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate. It may be used as monotherapy or in combination with methotrexate or other nonbiologic disease modifying anti rheumatic drugs (DMARDs).

The dosage of Xeljanz 5mg is twice-daily immediate-release (IR) formulation, and Xeljanz XR provides a once-daily (QD) dosing with extended-release (XR) formulation.

Xeljanz 5mg PMS collected approximately 750 patients in 6 years since it was approved in Korea. Althought Xeljanz XR extended-release tablet is an addition of formulation within the approved indication of Xeljanx 5mg, Pfizer Korea decided to conduct PMS of Xeljanz XR extended-release tablet to establish safety and effectiveness in Korean population. At least 200 patients will be enrolled in this study over the next four years after Xeljanz XR is approved.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Active moderate to severe rheumatoid arthritis patients who are prescribed with Xeljanz XR under normal clinical practice in Korea
Condition Active Moderate to Severe Rheumatoid Arthritis
Intervention Drug: Tofacitinib XR
Tofacitinib XR 11mg
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 Not yet recruiting
Estimated Enrollment
 (submitted: May 4, 2021)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 31, 2025
Estimated Primary Completion Date May 31, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Moderately to severely active RA in adult patients who have had an inadequate response or intolerance to methotrexate.
  2. Patients who have previously been given Xeljanz 5mg, who have changed Xeljanz XR, are also eligible for registration in the study.
  3. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria:

Patients meeting any of the following criteria will not be included in the study:

  1. Patients with a history of hypersensitivity to any ingredients of this product.
  2. Patients with serious infection (sepsis, etc.) 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) <1,000 cells/mm3. *
  6. Patients with a lymphocyte count <500 cells/mm3. *
  7. Patients with a hemoglobin level <9 g/dL. *
  8. Pregnant or possibly pregnant women. * Do not initiate Xeljanz XR in the following cases: ANC; absolute neutrophil count <1,000 cells/mm3 ALC; absolute lymphocyte count <500 cells/mm3 Hemoglobin<9 g/dL
Sex/Gender
Sexes Eligible for Study:All
Ages 18 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 Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT04876781
Other Study ID Numbers A3921369
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
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 2021