Clinical trial NCT04876781: Korean Post-marketing Surveillance for Xeljanz XR
Official title: Korean Post-marketing Surveillance for Xeljanz XR (Registered)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Active Moderate to Severe Rheumatoid Arthritis
Active Ankylosing Spondylitis
Active Psoriatic Arthritis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2021-05-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects administered with Xeljanz XR as a part of routine treatment who comply with the local labeling.

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.

Detailed description: This is a open-label, non-comparative, non-interventional, prospective, and multi-center study to further evaluate the safety and effectiveness of Xeljianz XR in routine clinical practice in Korea.

Safety is the primary interest of this study, which will be assessed based on adverse events (AEs) that occur during the 6 months from the first dose of Xeljanz XR. The efficacy endpoints will be the modified Disease Activity Score using 28 joint counts (DAS28) change from baseline, European League Against Rheumatism (EULAR) response, and American College of Rheumatology 20% improvement criteria (ACR20) response after treatment.

Eligibility criteria: Inclusion Criteria:

Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:

1. 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
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

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (AEs)
timeFrame: Maximum of 52 weeks from the time of initial administration of Xeljanz XR
Secondary outcomes:
measure: Change from baseline in Disease Activity Score based on 28-joints Count (DAS28)
timeFrame: Baseline, 52 weeks after treatment or within 30 days after last dose of medicinal product
measure: Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28
timeFrame: Baseline, 52 weeks after treatment or within 30 days after last dose of medicinal product
measure: Number of Participants With an American College of Rheumatology 20% (ACR20) Response
timeFrame: Baseline, 52 weeks after treatment or within 30 days after last dose of medicinal product
measure: Assessment of Ankylosing Spondylitis response (ASAS20)
timeFrame: Baseline, 52 weeks after treatment or within 30 days after last dose of medicinal product
measure: Changes from baseline in the number of tender joints and swollen joints
timeFrame: Baseline, 52 weeks after treatment or within 30 days after last dose of medicinal product
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Pfizer
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: