Clinical trial NCT04071405: Korea Post-marketing Surveillance for Xeljanz (Registered) in Ulcerative Colitis Patients
Official title: Korea Post-marketing Surveillance for Xeljanz (Registered) in Ulcerative Colitis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ulcerative Colitis
Keywords: Ulcerative colitis
Autoimmune Diseases
Immune System Diseases
Tofacitinib
Molecular Mechanisms of Pharmacological Action
Jak inhibitor
safety
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2019-08-28
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults aged 19 years and older with moderately to severely active ulcerative colitis

Brief summary: As required for new medications approved by the Ministry of Food and Drug Safety, safety and efficacy information should be provided for a minimum of 90 patients treated in the setting of routine practice during 4 years following approval (until 19 September 2022). Out of all the enrolled patients, at least 18 cases (20%) will be followed up until the 52nd week to see the long term safety of Xeljanz.

Detailed description: This is an open-label, non-comparative, non-interventional, prospective, and multi-center study conducted in Korean health care centers by accredited physicians (ie, investigators). The study population will be adult patients with moderately to severely active UC who have had an inadequate response or intolerance to the basic treatments or biological agents. Clinical Severity of Ulcerative Colitis is classified as mild, moderate, or severe based on the Mayo score or partial Mayo score. Xeljanz will be administered according to the "Dosage and Administration" of the approved labeling. There is no visit or activity mandated by this study. The investigator will collect patient data and record the information on each patient's case report form (CRF).

Eligibility criteria: Inclusion Criteria:

* Adult ulcerative colitis patients with moderately to severely active disease who has received at least 1 dose of Xeljanz according to the local labeling

Exclusion Criteria:

* Patients meeting any of the following criteria as per local labeling 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.
  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.

Primary outcomes:
measure: Percentage of Participants With Adverse Events, Adverse Drug Reactions, Serious Adverse Events and Serious Adverse Drug Reactions
timeFrame: From first dose of Xeljanz until 52 weeks
measure: Number of Participants With Adverse Events, Adverse Drug Reactions, Serious Adverse Events and Serious Adverse Drug Reactions in Long Term Users
timeFrame: From first dose of Xeljanz until 52 weeks
measure: Percentage of Participants With Unexpected Adverse Events (AE), Unexpected Adverse Drug Reactions, Unexpected Serious Adverse Events (SAE), and Unexpected Serious Adverse Drug Reactions
timeFrame: From first dose of Xeljanz until 52 weeks
measure: Number of Participants With Unexpected Adverse Events, Unexpected Adverse Drug Reactions, Unexpected Serious Adverse Events, and Unexpected Serious Adverse Drug Reactions in Long Term Users
timeFrame: From first dose of Xeljanz until 52 weeks
measure: Percentage of Participants With Adverse Events of Special Interest
timeFrame: From first dose of Xeljanz until 52 weeks
measure: Number of Participants With Adverse Events of Special Interest in Long Term Users
timeFrame: From first dose of Xeljanz until 52 weeks
measure: Number of Participants With Adverse Events by Their Severity
timeFrame: From first dose of Xeljanz until 52 weeks
measure: Number of Participants With Adverse Events by Their Severity in Long Term Users
timeFrame: From first dose of Xeljanz until 52 weeks
measure: Number of Participants With Adverse Events by Their Outcomes
timeFrame: From first dose of Xeljanz until 52 weeks
measure: Number of Participants With Adverse Events by Their Outcomes in Long Term Users
timeFrame: From first dose of Xeljanz until 52 weeks
measure: Number of Participants With Adverse Events by Their Seriousness
timeFrame: From first dose of Xeljanz until 52 weeks
measure: Number of Participants With Adverse Events by Their Seriousness in Long Term Users
timeFrame: From first dose of Xeljanz until 52 weeks
measure: Number of Participants With Adverse Events by Action Taken
timeFrame: From first dose of Xeljanz until 52 weeks
measure: Number of Participants With Adverse Events by Action Taken in Long Term Users
timeFrame: From first dose of Xeljanz until 52 weeks
measure: Number of Participants With Adverse Events by Their Causality Assessment
timeFrame: From first dose of Xeljanz until 52 weeks
measure: Number of Participants With Adverse Events by Their Causality Assessment in Long Term Users
timeFrame: From first dose of Xeljanz until 52 weeks
measure: Number of Participants With Adverse Events by Their Other Causality Assessment
timeFrame: From first dose of Xeljanz until 52 weeks
measure: Number of Participants With Adverse Events by Their Other Causality Assessment in Long Term Users
timeFrame: From first dose of Xeljanz until 52 weeks
Secondary outcomes:
measure: Mayo Index, Mayo Score and Partial Mayo Score at Baseline, Week 8, Week 16 and Week 24
timeFrame: Baseline, Week 8, Week 16 and Week 24
measure: Mayo Index, Mayo Score and Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52 for Long Term Users
timeFrame: Baseline, Week 8, Week 16, Week 24 and Week 52
measure: Number of Participants With Mucosal Healing at Week 8, Week 16 and Week 24
timeFrame: Week 8, Week 16 and Week 24
measure: Number of Participants With Mucosal Healing at Week 8, Week 16, Week 24 and Week 52 for Long Term Users
timeFrame: Week 8, Week 16, Week 24 and Week 52
measure: Number of Participants With Remission at Week 8, Week 16 and Week 24
timeFrame: Week 8, Week 16, and Week 24
measure: Number of Participants With Remission at Week 8, Week 16, Week 24 and Week 52 for Long Term Users
timeFrame: Week 8, Week 16, Week 24 and Week 52
measure: Number of Participants With Clinical Response at Week 8, Week 16 and Week 24
timeFrame: Week 8, Week 16 and Week 24
measure: Number of Participants With Clinical Response at Week 8, Week 16, Week 24 and Week 52 for Long Term Users
timeFrame: Week 8, Week 16, Week 24 and Week 52
measure: Number of Participants According to Final Effectiveness Evaluation by Investigator
timeFrame: From first dose of Xeljanz until 24 weeks
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: