Ulcerative colitis
Conditions
Interventions
None listed
Sponsors
Janssen Pharmaceutical K.K
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.male or female aged at least 16 years of age 2.must have a confirmed diagnosis of ulcerative colitis in accordance with local practice 3.has a current ulcerative colitis severity that is judged by the treating physician to be moderate to severe (being a partial Mayo score of 5 to 9, inclusive) 4.a decision has been made by the treating physician and the patient within routine clinical practice to commence treatment with ustekinumab, having been deemed to have an inadequate response to, or intolerant to, previous UC therapy 5.must sign an ICF allowing data collection and source data verification in accordance with local requirements. If the subject is 16 to 19, informed consent might be obtained from each study subject according to the regulation of institution/hospital and their legally acceptable representative must sign an ICF. 6.must be able to read, understand, and complete patient-reported outcome instruments, and intend to cooperate with completion of patient-reported outcome instruments using smartphone/tablet.
Exclusion criteria
Exclusion criteria: 1.has ever previously received ustekinumab (including clinical trial use) 2. based on physician judgement has i) severe extensive colitis and is at imminent risk of colectomy OR ii) a stoma or history of a fistula OR iii) previously had extensive colonic resection (e.g., less than 30 cm of colon remaining) OR iv) current fulminant colitis OR v) currently hospitalized for worsening of UC-related symptoms (Not excluded if the reason for hospitalization is first dose of ustekinumab ). 3. are currently receiving, or have received within the past 3 months, systemic treatment with a biologic therapy for any other indication (e.g. Crohn's disease, psoriasis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis) 4. received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 3 months before the start of the study or the first data collection time point 5. currently enrolled in an interventional study or another Janssen-sponsored observational study (including post-marketing surveillance)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| to describe the initial response to ustekinumab induction treatment for UC in Japan | — |
Secondary
| Measure | Time frame |
|---|---|
| to investigate the relationship between the treatment response obtained at 8 weeks and earlier indicators of response to describe the ustekinumab treatment pattern for patients initiating ustekinumab for UC in Japan, in particular the dosing interval for maintenance therapy | — |
Countries
Japan
Contacts
Public ContactKatsumasa Nagano
Janssen Pharmaceutical K.K Medical Affairs Division
Outcome results
None listed