Symptom improvement of ulcerative colitis after an induction dose of ustekinumab in Japanese clinical practice, measured using patient-reported outcomes

Not Applicable

• Conditions: lcerative colitis

• Registration Number: JPRN-UMIN000043753
• Lead Sponsor: Janssen Pharmaceutical K.K

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-31
• Study Completion: 2022-12-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

Not provided

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)

Study & Design

• Study Type: Observational
• Study Design: Not specified