A Study of Symptom Improvement of Ulcerative Colitis After an Induction Dose of Ustekinumab in Japanese Clinical Practice

Ulcerative Colitis Clinical Trial

Official title:

Symptom Improvement of Ulcerative Colitis After an Induction Dose of Ustekinumab in Japanese Clinical Practice, Measured Using Patient-Reported Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04963725
• Other study ID #: CR108984
• Secondary ID: CNTO1275UCO4004
• Status: Completed
• Start date: July 18, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: December 2023
• Source: Janssen Pharmaceutical K.K.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• Ustekinumab
No intervention or treatment will be administered as part of this study. Data available per routine clinical practice at clinic visits as well as directly from participant using a smartphone/tablet application will be collected.

Locations

Country	Name	City	State
Japan	Juntendo University Hospital	Bunkyo-ku
Japan	Tokyo Medical and Dental University Hospital	Bunkyo-Ku
Japan	Chiba University Hospital	Chiba
Japan	Toho University Sakura Medical Center	Chiba
Japan	Fukuoka University Hospital	Fukuoka
Japan	Kyushu University Hospital	Fukuoka
Japan	Hamamatsu University Hospital	Hamamatsu
Japan	Shimane University Hospital	Izumo
Japan	Tsujinaka Hospital Kashiwanoha	Kashiwa
Japan	Saitama Medical University Saitama Medical Center	Kawagoe
Japan	University Hospital Kyoto Perfectural University of Medicine	Kyoto
Japan	Kitasato University Kitasato Institute Hospital	Minato-ku
Japan	Kyorin University Hospital	Mitaka
Japan	Nagoya University Hospital	Nagoya
Japan	Ishida Clinic of IBD and Gastroenterology	Oita
Japan	Okayama University Hospital	Okayama
Japan	Shiga University of Medical Science Hospital	Otsu
Japan	Sapporo Medical University Hospital	Sapporo
Japan	Tohoku University Hospital	Sendai
Japan	Osaka Medical and Pharmaceutical University Hospital	Takatsuki
Japan	Tokyo Yamate Medical Center	Tokyo
Japan	Toyama Prefectural Central Hospital	Toyama
Japan	Yokkaichi Hazu Medical Center	Yokkaichi

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Pharmaceutical K.K.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With a Rectal Bleeding Score of 0 or 1	The rectal bleeding scores of 0 and 1 using physician's global assessment will be reported where 0 indicates 'No blood seen' and 1 indicates 'Streaks of blood with stool less than half the time'.	Up to Week 8
Primary	Percentage of Participants With a Stool Frequency Score of 0 or 1	The stool bleeding scores of 0 and 1 using physician's global assessment will be reported where 0 will indicate 'Normal number of stools' and 1 will indicate '1 to 2 stools more than normal'.	Up to Week 8
Secondary	Change From Baseline in Rectal Bleeding Score Through Week 8	Change from baseline in rectal bleeding score through Week 8 will be reported.	Baseline, Up to Week 8
Secondary	Change from Baseline in Stool Frequency Score Through Week 8	Change from baseline in stool frequency score through Week 8 will be reported.	Baseline, Up to Week 8
Secondary	Percentage of Participants with a Reduction in Rectal Bleeding Score of Greater than or Equal to (>=) 1 From Baseline	Percentage of participants with a reduction in rectal bleeding score of >= 1 from baseline through Week 8 will be reported.	Up to Week 8
Secondary	Percentage of Participants with Reduction in Stool Frequency Score of >= 1 From Baseline	Percentage of participants with a reduction in stool frequency score of >= 1 from baseline through Week 8 will be reported.	Up to Week 8
Secondary	Change from Baseline in Calculated Partial Mayo Score at Week 8 and Week 16 or Week 20	The partial Mayo (pMayo) is a composite score to indicate ulcerative colitis status without the requirement for endoscopy. It records participant-reported stool frequency over three days relative to normal on a 0-3 subscale (stool frequency, rectal bleeding, and physician global assessment of disease severity) each graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 9; where higher scores indicating more severe disease.	Baseline, Week 8 and Week 16 or Week 20
Secondary	Change from Baseline in Rectal Bleeding Score at Week 16 or Week 20	Change from baseline in rectal bleeding score Week 16 or Week 20 will be reported.	Baseline, Week 16 or Week 20
Secondary	Change from Baseline in Stool Frequency Score at Week 16 or Week 20	Change from baseline in stool frequency score at Week 16 or Week 20 will be reported.	Baseline, Week 16 or Week 20
Secondary	Change from Baseline in Abdominal Pain Through Week 8	Change from baseline in abdominal pain through Week 8 will be reported. Abdominal Pain will be evaluated based on numeric rating scale (NRS) ranging from 0 to 10 with lower score of 0 indicating 'no pain', score of 5 indicating 'moderate pain' and higher score of 10 indicating 'worst pain'. The abdominal pain score represents the most severe pain of the day.	Baseline, Up to Week 8
Secondary	Percentage of Participants with Presence of Nocturnal Diarrhea	Percentage of participants with presence of nocturnal diarrhea will be reported. Nocturnal Diarrhea will be evaluated based on 'Yes/No' questionnaire, completed by participants using a smartphone/tablet-based application.	Up to Week 8
Secondary	Percentage of Participants with Presence of Tenesmus	Percentage of participants with presence of tenesmus will be reported. Tenesmus will be evaluated based on 'Yes/No' questionnaire, completed by participants using a smartphone/tablet-based application.	Up to Week 8
Secondary	Percentage of Participants with Perceived Improvement in Ulcerative Colitis (UC)	Percentage of participants with perceived improvement in UC will be reported. Perceived Improvement in UC will be evaluated based on NRS ranging from 0 to 10 with lower score of 0 indicating 'completely better (no UC symptoms)', score of 5 indicating 'starting condition (condition immediately before the induction of ustekinumab)' and higher score of 10 indicating 'poor condition (lots of UC symptoms).' Improvement is shown by recording a number less than 5 and worsening by recording a number greater than 5.	Up to Week 8