Ulcerative colitis
Conditions
Interventions
None listed
Sponsors
Ng Pauline
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Male or female aged at least 16 years at baseline 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 MES >= 2 or Mayo >= 6) 4.Patients are planning to undergo examinations to assess UC disease activity in daily practice. 5.One and more IUS pathological parameter 6.Must sign an ICF allowing data collection and source data verification in accordance with local requirements. For patients aged 16 to 19, informed consent may be obtained from each study patient according to institutional/hospital regulations, and their legally acceptable representative must sign the ICF 7.Must be able to read, understand, and complete patient-reported outcome instruments, and must intend to cooperate with the completion of patient-reported outcome instruments using a smartphone/tablet.
Exclusion criteria
Exclusion criteria: 1.Has ever previously received Tremfya (guselkumab). 2.Contraindicated to guselkumab per the label. 3.Are currently receiving, or have received within the past 3 months, systemic treatment with JAK inhibitors, S1PR modulators, and other biologic agents for any other indication (e.g., Crohn's disease, psoriasis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis). 4.Has received oral corticosteroids at a prednisone-equivalent dose of >30mg/day (however, patients who do not respond within weeks 1-2 and have started tapering are excluded). 5.Based on physician judgment, has i) severe extensive colitis and is at imminent risk of colectomy, OR ii) a stoma or a history of a fistula, OR iii) previously had extensive colonic resection (e.g., less than 30 cm of colon remaining). 6.Has a diagnosis of proctitis or undetermined disease type. 7.Have suspected concomitant colitis (e.g., infectious enteritis, diverticulitis, ischemic colitis). 8.Has severe obesity that hampers the IUS examination. 9.Currently enrolled in an interventional study or another Janssen-sponsored observational study. 10.Is participating in other clinical trials of molecular targeted drugs (e.g., JAK inhibitors, S1PR modulators, and other biologic agents).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients achieving complete transmural healing at 12 weeks after the administration of GUS. | — |
Secondary
| Measure | Time frame |
|---|---|
| The changes in mean BWT from baseline to 12 weeks after the administration of GUS, measured by IUS. The proportion of patients achieving transmural response and simplified transmural healing at 4-, 8-, and 12-weeks post-administration. To evaluate the proportion of patients achieving complete transmural healing at 4- and 8-weeks post-administration. The following symptomatic measures will be evaluated among patients achieving or not achieving transmural response, simplified, and complete transmural healing at 4, 8, and 12 weeks: -Rectal Bleeding, Stool Frequency, Clinical Response, Clinical Remission, Symptomatic remission, Abdominal Pain, Tenesmus, Nocturnal Diarrhea, Patient Perception of Improvement in UC, Bowel Urgency To evaluate the change in mean CRP, fecal calprotectin, and LRG from baseline to 12 weeks after the administration of GUS. | — |
Contacts
Public ContactYoko Takahashi
Janssen Pharmaceutical K.K.
Outcome results
None listed