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Korean Post-marketing Surveillance for Xeljanz

Last updated on November 19, 2019

FOR MORE INFORMATION
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, 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.
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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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Descriptive Information
Brief TitleKorean Post-marketing Surveillance for Xeljanz
Official TitleKOREAN POST-MARKETING SURVEILLANCE FOR XELJANZ (REGISTERED)
Brief SummaryThe 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 DescriptionNot Provided
Study TypeObservational
Study DesignObservational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study Populationadult 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
InterventionNot Provided
Study Groups/CohortsNot 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 StatusRecruiting
Estimated Enrollment
 (submitted: December 2, 2016)
3000
Original Estimated EnrollmentSame as current
Estimated Study Completion DateJanuary 20, 2020
Estimated Primary Completion DateJanuary 2, 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
Ages19 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
Contacts
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location CountriesKorea, Republic of
Removed Location Countries  
 
Administrative Information
NCT NumberNCT02984020
Other Study ID NumbersA3921249
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot 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/da....
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateOctober 2019

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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