Korean Post-marketing Surveillance for Xeljanz XR

NCT04876781 | Recruiting FDA Drug

• 2 other identifiers: A3921369NCT04876781
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Xeljanz XR extended-release tablets 11 mg (Tofacitinib citrate) is a drug subject to the risk management plan in accordance with Article 4-1-11 of the "Regulation on Safety of Medicinal Products, etc." in Korea. As part of additional pharmacovigilance activity, this Post-marketing Surveillance (PMS) was planned to evaluate safety and effectiveness of Xeljanz XR under routine clinical practice. At least 200 patients with Rheumatoid Arthritis, Psoriatic Arthritis, or Ankylosing Spondylitis who were treated with Xeljanz XR will be enrolled about four years.

Conditions

Active Moderate to Severe Rheumatoid Arthritis; Active Ankylosing Spondylitis; Active Psoriatic Arthritis

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment Emergent Adverse Events (AEs)

  AE is any untoward medical occurrence attributed to study drug in a participant who received study drug. Serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to end of this PMS after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to Xeljanz XR was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.

  Maximum of 52 weeks from the time of initial administration of Xeljanz XR

Secondary Outcomes (5)

• Change from baseline in Disease Activity Score based on 28-joints Count (DAS28)

  Baseline, 52 weeks after treatment or within 30 days after last dose of medicinal product

• Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28

  Baseline, 52 weeks after treatment or within 30 days after last dose of medicinal product

• Number of Participants With an American College of Rheumatology 20% (ACR20) Response

  Baseline, 52 weeks after treatment or within 30 days after last dose of medicinal product

• Assessment of Ankylosing Spondylitis response (ASAS20)

  Baseline, 52 weeks after treatment or within 30 days after last dose of medicinal product

• Changes from baseline in the number of tender joints and swollen joints

  Baseline, 52 weeks after treatment or within 30 days after last dose of medicinal product

Interventions

Tofacitinib XR DRUG

Tofacitinib XR 11mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects administered with Xeljanz XR as a part of routine treatment who comply with the local labeling.

You may qualify if:

• Xeljanz® XR is administered according to indications on the approved labeling
• Treatment of moderate to severe active RA in adult patients (18 years of age or older) who have had an inadequate response or are intolerant to methotrexate
• In combination with methotrexate, treatment of active psoriatic arthritis (PsA) in adult patients (18 years of age or older) who have had an inadequate response or who have been intolerant to a prior DMARD therapy.
• Treatment of active ankylosing spondylitis (AS) in adult patients (18 years of age or older) who have responded inadequately to conventional therapy
• In the following patients, Xeljanz® XR should be used only for patients who have had an inadequate response or are intolerant to the existing treatment.
• A. Patients aged 65 or older B. Cardiovascular high-risk patients C. Patients at risk for malignancy
• Patients who have previously been given Xeljanz 5mg, who have changed Xeljanz® XR, are also eligible for registration in the study
• 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

You may not qualify if:

• Patients meeting any of the following criteria will not be included in the study:
• Patients with a history of hypersensitivity to any ingredients of this product.
• Patients with serious infection (sepsis, etc.) or active infection including localized infection.
• Patients with active tuberculosis.
• Patients with severe hepatic function disorder.
• Patients with an absolute neutrophil count (ANC) \<1,000 cells/mm3. \*
• Patients with a lymphocyte count \<500 cells/mm3. \*
• Patients with a hemoglobin level \<9 g/dL. \*
• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer

Seoul, South Korea

RECRUITING

Related Links

• To obtain contact information for a study center near you, click here.

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: May 6, 2021
• Study Start: January 12, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)