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Korean Post-marketing Surveillance for Xeljanz

Last updated on October 6, 2018

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Study Location
Chonbuk National University Hospital, Department of Rheumatology
Chonju, Chonbuk, 561-712 Korea, Republic of
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid 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.
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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.

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)

6. Patients with a lymphocyte count

7. Patients with a hemoglobin concentration

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)

NCT02984020
Pfizer
Recruiting
Korean Post-marketing Surveillance for Xeljanz

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Korean Post-marketing Surveillance for Xeljanz
Korean Post-marketing Surveillance For Xeljanz (Registered)
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.
Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
adult rheumatoid arthritis taking tofacitinib within label as Ministry of Food and Drung Safety in Korea has approved
Rheumatoid Arthritis
Not Provided
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
3000
January 2, 2020
January 2, 2020   (Final data collection date for primary outcome measure)

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.

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

Sexes Eligible for Study: All
19 Years and older   (Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Korea, Republic of
 
 
NCT02984020
A3921249
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2017

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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.

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