Ulcerative Colitis
Conditions
Interventions
None listed
Sponsors
Janssen Pharmaceutical K.K.
Fukuoka University Faculty of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Age 16 years or older at the time of obtaining informed consent. 2.Ability to provide informed consent and for non-adults under 18 years of age, the consent of their legally acceptable representative must be obtained. 3.Subjects who have a PRO2 score (total of stool frequency score and rectal bleeding score) of 3 or greater at the time of obtaining informed consent. 4.Subjects who will be initiating treatment intensification to treat UC. The treatment intensification is defined as initiating treatment (or increasing dose) with advanced therapies (infliximab, adalimumab, golimumab, ustekinumab, vedolizumab, upadacitinib, filgotinib, carotegrast methyl, or tacrolimus), oral corticosteroids or immunosuppressants (azathioprine, 6-mercaptopurine) for UC patients with exacerbation. 5.Subjects who are able and willing to answer to the PROs, 6.Subjects who are able and willing to wear AdtiGraph LEAP device as direction by the Investigator. 7.Subjects who have a personal smartphone which can download the required Apps if subjects use their own device. (Allow the use of rental device prepared by sponsor if for some reason a personal smartphone is not available or unpreferable)
Exclusion criteria
Exclusion criteria: 1.Current pregnancy 2.Current malignancy, or active treatment for previously diagnosed malignancy. 3.Subjects with serious comorbidity including immunodeficiency, myocardial infarction, stroke, renal or hepatic failure, infection such as abscess, opportunistic infection, or sepsis. 4.Subjects currently enrolled or plan to be enrolled (during this study period) in another Janssen-sponsored investigational study or an observational study. 5.Subjects with pacemaker or defibrillators. 6.The use of medications known to affect autonomic nervous system function or the cardiovascular system including beta blockers, calcium channel blockers, and benzodiazepines. 7.The regular use of antidiarrheal agents. 8.A history of bowel surgery. 9.Subjects who need to begin treatment intensification on the same day of the decision of treatment intensification. (Subjects who are unable to obtain baseline physiological data/The baseline period is acceptable for 5 or 6 days depending on the subject's visit availability, 1-4 days is insufficient as a baseline period and should be discontinued)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoints PRO2 score (0 - 6) at each measurement point (day). Heart rate variability (HRV) measures at each measurement point (day) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints PRO2 score changes from baseline (BL) at each measurement point (day). Physiological measures (vital signs, physical activity, sleep) at each measurement point (day) as well as change from BL at each measurement point (day). Clinical response (patients achieving 50% reduction of PRO2 from BL) and clinical remission (patients achieving PRO2 = 0) at day 28. Other secondary endpoints Number of stools at night at each measurement point (day) Total bowel urgency score (0-12) at each measurement point (day) Total tenesmus score (0-12) at each measurement point (day) Total abdominal pain score (0-12) at each measurement point (day) Total sleep disturbance score (4-20) at each measurement point (day) Total fatigue score (4-20) at each measurement point (day) Total depression score (4-20) at each measurement point (week) Total anxiety score (4-20) at each measurement point (week) Total stress score (0-16) at each measurement point (week) | — |
Countries
Japan
Contacts
Public ContactTomoyuki Inoue
Janssen Pharmaceutical K.K. Medical Affairs
Outcome results
None listed