Clinical trial NCT04963725: A Study of Symptom Improvement of Ulcerative Colitis After an Induction Dose of Ustekinumab in Japanese Clinical Practice
Official title: Symptom Improvement of Ulcerative Colitis After an Induction Dose of Ustekinumab in Japanese Clinical Practice, Measured Using Patient-Reported Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ulcerative Colitis
Lead sponsor: Janssen Pharmaceutical K.K.
Sponsor class: INDUSTRY
First posted: 2021-07-15
Enrollment: 137
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population will consist of participants who have had previously inadequate response, or have been intolerant to, conventional or biologic therapies and will be initiating ustekinumab for their ulcerative colitis.

Brief summary: The purpose of this study is to describe the initial response to ustekinumab induction treatment for ulcerative colitis (UC) in Japan.


Eligibility criteria: Inclusion Criteria:

* Must have a confirmed diagnosis of ulcerative colitis (UC) in accordance with local practice
* Has a current UC severity that is judged by the treating physician to be moderate to severe (being a partial Mayo score of 5 to 9, inclusive)
* A decision has been made by the treating physician and the participant within routine clinical practice to commence treatment with ustekinumab, having been deemed to have an inadequate response to, or intolerant to, previous UC therapy
* Must sign an informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements. If the participant is 16 to 19, informed consent might be obtained from each study participant according to the regulation of institution/hospital and their legally acceptable representative must sign an ICF
* Must be able to read, understand, and complete participant-reported outcome instruments, and intend to cooperate with completion of participant-reported outcome instruments using smartphone/tablet

Exclusion Criteria:

* Has ever previously received ustekinumab (including clinical trial use)
* Are currently receiving, or have received within the past 3 months, systemic treatment with a biologic therapy for any other indication (example Crohn's disease, psoriasis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis)
* 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
* Currently enrolled in an interventional study or another Janssen-sponsored observational study (including post-marketing surveillance)
* 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 (example, less than 30 centimeter (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)

Primary outcomes:
measure: Percentage of Participants With a Rectal Bleeding Score of 0 or 1
timeFrame: Up to Week 8
measure: Percentage of Participants With a Stool Frequency Score of 0 or 1
timeFrame: Up to Week 8
Secondary outcomes:
measure: Change From Baseline in Rectal Bleeding Score Through Week 8
timeFrame: Baseline, Up to Week 8
measure: Change from Baseline in Stool Frequency Score Through Week 8
timeFrame: Baseline, Up to Week 8
measure: Percentage of Participants with a Reduction in Rectal Bleeding Score of Greater than or Equal to (>=) 1 From Baseline
timeFrame: Up to Week 8
measure: Percentage of Participants with Reduction in Stool Frequency Score of >= 1 From Baseline
timeFrame: Up to Week 8
measure: Change from Baseline in Calculated Partial Mayo Score at Week 8 and Week 16 or Week 20
timeFrame: Baseline, Week 8 and Week 16 or Week 20
measure: Change from Baseline in Rectal Bleeding Score at Week 16 or Week 20
timeFrame: Baseline, Week 16 or Week 20
measure: Change from Baseline in Stool Frequency Score at Week 16 or Week 20
timeFrame: Baseline, Week 16 or Week 20
measure: Change from Baseline in Abdominal Pain Through Week 8
timeFrame: Baseline, Up to Week 8
measure: Percentage of Participants with Presence of Nocturnal Diarrhea
timeFrame: Up to Week 8
measure: Percentage of Participants with Presence of Tenesmus
timeFrame: Up to Week 8
measure: Percentage of Participants with Perceived Improvement in Ulcerative Colitis (UC)
timeFrame: Up to Week 8
Other outcomes:
Locations:
city: Bunkyo Ku
country: Japan
facility: Tokyo Medical and Dental University Hospital
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital
city: Chiba
country: Japan
facility: Chiba University Hospital
city: Chiba
country: Japan
facility: Toho University Sakura Medical Center
city: Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Fukuoka
country: Japan
facility: Fukuoka University Hospital
city: Hamamatsu
country: Japan
facility: Hamamatsu University Hospital
city: Izumo
country: Japan
facility: Shimane University Hospital
city: Kashiwa
country: Japan
facility: Tsujinaka Hospital Kashiwanoha
city: Kawagoe
country: Japan
facility: Saitama Medical University Saitama Medical Center
city: Kyoto
country: Japan
facility: University Hospital Kyoto Prefectural University of Medicine
city: Minato-ku
country: Japan
facility: Kitasato University Kitasato Institute Hospital
city: Mitaka
country: Japan
facility: Kyorin University Hospital
city: Nagoya
country: Japan
facility: Nagoya University Hospital
city: Oita
country: Japan
facility: Ishida Clinic of IBD and Gastroenterology
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Otsu
country: Japan
facility: Shiga University of Medical Science Hospital
city: Sapporo
country: Japan
facility: Sapporo Medical University Hospital
city: Sendai
country: Japan
facility: Tohoku University Hospital
city: Shinjuku-ku
country: Japan
facility: Tokyo Yamate Medical Center
city: Takatsuki
country: Japan
facility: Osaka Medical and Pharmaceutical University Hospital
city: Toyama
country: Japan
facility: Toyama Prefectural Central Hospital
city: Yokkaichi
country: Japan
facility: Yokkaichi Hazu Medical Center
Study officials:
affiliation: Janssen Pharmaceutical K.K.
name: Janssen Pharmaceutical K.K., Japan Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Matsuoka K, Nagano K, Nagasaki S, Murata Y, Hisamatsu T. Symptom Improvement of ulceRative colitis after an Induction dose of UStekinumab in Japanese clinical practice (SIRIUS), measured using patient-reported outcomes: a prospective observational study. BMJ Open. 2022 May 4;12(5):e060081. doi: 10.1136/bmjopen-2021-060081.