A Pilot Study to Explore How Vital Signs Correlate with Symptoms in UC Patients

UMIN ID: UMIN000054412

Registered date:01/06/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Ulcerative Colitis
• Date of first enrollment: 2024/06/01
• Target sample size: 15
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: Primary endpoints PRO2 score (0 - 6) at each measurement point (day). Heart rate variability (HRV) measures at each measurement point (day)
• Secondary Outcome: 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)

Key inclusion & exclusion criteria

• Age minimum: 16years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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)

Related Information

• Primary Sponsor: Janssen Pharmaceutical K.K.
• Secondary Sponsor: Fukuoka University Faculty of Medicine
• Source(s) of Monetary Support: Janssen Pharmaceutical K.K.