Korean Post-marketing Surveillance for Xeljanz

Rheumatoid Arthritis Clinical Trial

Official title:

Korean Post-marketing Surveillance for Xeljanz(Registered) in Rheumatoid Arthritis and Psoriatic Arthritis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02984020
• Other study ID #: A3921249
• Status: Completed
• Start date: May 13, 2016
• Est. completion date: June 9, 2022

Study information

• Verified date: September 2022
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1040
• Est. completion date: June 9, 2022
• Est. primary completion date: June 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Arthritis, Rheumatoid
• Psoriatic Arthritis
• Rheumatoid Arthritis

Locations

Country	Name	City	State
Korea, Republic of	Korea University Ansan Hospital	Ansan, Gyeonggi-do
Korea, Republic of	Inje University Busan Paik hospital	Busan
Korea, Republic of	Inje University Haeundae Paik Hospital	Busan
Korea, Republic of	Kosin University Gospel Hospital	Busan
Korea, Republic of	Chonbuk National University Hospital, Department of Rheumatology	Chonju	Chonbuk
Korea, Republic of	Soonchunhyang University Cheonan Hospital, Department of Rheumatology	Chunan-si	Chungcheongnam-do
Korea, Republic of	Hallym University Chuncheon Sacred Heart Hospital	Chuncheon-si	Gangwon-do
Korea, Republic of	Chungbuk National University Hospital	Chungcheongbuk-do
Korea, Republic of	Daegu Catholic University Medical Center, Department of Rheumatology	Daegu
Korea, Republic of	Eulji University Hospital, Internal Medicine, Rheumatology	Daejeon
Korea, Republic of	Chosun University Hospital, Rheumatism Department	Dong Gu	Gwang JU
Korea, Republic of	Yongin Severance Hospital	Giheung-gu, Yongin-si, Gyeonggi-do
Korea, Republic of	Myongji Hospital / Rheumatology	Goyang-si	Deogyang-gu
Korea, Republic of	Inje University IlsanPaik Hospital	Goyang-si, Gyeonggi-do
Korea, Republic of	Dongguk University Ilsan Medical Center	Gyeonggi-do
Korea, Republic of	Wonkwang University Hospital / Division of Rheumatology	Iksan	Jeonlabuk-do
Korea, Republic of	Division of Rheumatology	Incheon
Korea, Republic of	Gachon University Gil Hospital	Incheon
Korea, Republic of	Jeju National University Hospital	Jeju Special Self-Goverming Province
Korea, Republic of	Keimyung University Dongsan Medical Center	Jung-Gu	Daegu
Korea, Republic of	Division of Rheumatology	Metropolitan City, Daejeon
Korea, Republic of	Dong-A University Hospital	Pusan
Korea, Republic of	Pusan National University Hospital	Pusan
Korea, Republic of	Kongyang University Hospital / Rheumatology	Seo-gu	Daejon
Korea, Republic of	CHA Bundang Medical Center	Seongnam-si	Gyeonggi-do
Korea, Republic of	Division of Rheumatology	Seongnam-si	Gyeongg-do
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do
Korea, Republic of	Division of Rheumatology	Seoul
Korea, Republic of	Division of Rheumatology, SMG-SNU Boramae Medical Center	Seoul
Korea, Republic of	Eulji Medical Center	Seoul
Korea, Republic of	Ewha Womans University Mokdong Hospital	Seoul
Korea, Republic of	Hallym University Kangnam Sacred Heart Hospital	Seoul
Korea, Republic of	Hanyang Rheuma Uhm Wan-Sik Clinic	Seoul
Korea, Republic of	Hanyang University Hospital, Department of Rheumatology	Seoul
Korea, Republic of	Konkuk University Medical Center	Seoul
Korea, Republic of	Kyung Hee University Hospital	Seoul
Korea, Republic of	Kyung Hee University Hospital at Gangdong / Rheumatology	Seoul	Gangdong-gu
Korea, Republic of	Kyung Hee University Medical Center	Seoul
Korea, Republic of	Kyunghee University East-West Neo Medical Center, 149 Sangil-dong, Gangdong-gu	Seoul
Korea, Republic of	Samsung Medical Center, Division of Rheumatology, Department of Medicine	Seoul
Korea, Republic of	Seoul National University Hospital, Department of Internal Medicine	Seoul
Korea, Republic of	Seoul National University Hospital, Rheumatology, Internal Medicine	Seoul
Korea, Republic of	Soonchunhyang University Hospital Seoul/Department of Rheumatology	Seoul
Korea, Republic of	The Catholic University of Korea, Kangnam St. Mary's Hospital/ Rheumatology, Internal Medicine	Seoul
Korea, Republic of	The Catholic University of Korea, Seoul St. Mary's Hospital/ Rheumatology, Internal Medicine	Seoul
Korea, Republic of	VHS Medical Center / Rheumatologist	Seoul	Gangdong-gu
Korea, Republic of	Ajou University Hospital, Department of Rheumatology	Suwon-si	Kyeongki-do
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan-si	Gyeongsangnam-do
Korea, Republic of	Yangsan Hospital-Pusan National University	Yangsan-si	Gyeongsangnam-do

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events (AE)	incidence of AEs investigated during the re-examination period presented with 95% confidence interval.	Up to 6 months from time of first treatment
Secondary	Change from baseline in Disease Activity Score based on 28-joints Count (DAS28)	DAS28, a modified version of the original Disease Activity Score (DAS), is a quantitative measure of disease activity used to monitor the treatment of RA.	Baseline, 6 months after treatment or within 30 days after last dose of medicinal product
Secondary	Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28	The Disease Activity Score Based on 28-joints Count based (DAS28-based) EULAR response criteria is used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached.	Baseline, 6 months after treatment or within 30 days after last dose of medicinal product
Secondary	In case of PsA, Number of active joints, including number of tender and swollen joints	In the case of PsA, DAS28 calculation is the same as calculation of RA above.	Baseline, 3months after treatment or within 30 days after last dose of medicinal product

External Links

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