UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054412 |
|---|---|
| Receipt number | R000062149 |
| Scientific Title | A Pilot Study to Explore How Vital Signs Correlate with Symptoms in UC Patients |
| Date of disclosure of the study information | 2024/06/01 |
| Last modified on | 2025/11/15 13:16:23 |
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Basic information
Public title
A Pilot Study to Explore How Vital Signs Correlate with Symptoms in UC Patients
Acronym
A Pilot Study to Explore How Vital Signs Correlate with Symptoms in UC Patients
Scientific Title
A Pilot Study to Explore How Vital Signs Correlate with Symptoms in UC Patients
Scientific Title:Acronym
A Pilot Study to Explore How Vital Signs Correlate with Symptoms in UC Patients
Region
| Japan |
Condition
Condition
Ulcerative Colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Primary objective
The primary objective of this study is to assess the association between HRV derived from a wearable device and PRO2 (total of stool frequency score and rectal bleeding score) in UC patients.
Secondary objective
The secondary objective is to assess the association between physiological measures (including vital signs, physical activities, and sleep) derived from a wearable device and various PROs (PRO2, nocturnal diarrhea, bowel urgency, tenesmus, abdominal pain, sleep, fatigue depression, anxiety, and stress) in UC patients.
Basic objectives2
Others
Basic objectives -Others
The group of Mt Sinai demonstrated that longitudinal HRV measurements (LF, HF, LF/HF and RMSSD), obtained with a wearable device over a 9-month period were associated with Perceived Stress Scale (PSS-4) (LFHF, P = 0.04; RMSSD, P = 0.04). The HRV was associated with UC symptoms, SCCAI (LF/HF, P = 0.03), CRP (HF, P < 0.001; LF, P < 0.001; RMSSD, P < 0.001), and fecal calprotectin (HF, P < 0.001; LF, P < 0.001; RMSSD, P < 0.001; LF/HF, P < 0.001). Changes in HRV indices from baseline developed prior to the identification of a symptomatic or inflammatory flare (HF, P < 0.001; LF, P < 0.001; RMSSD, P < 0.001; LF/HF, P < 0.001) in UC patients.[1] This study focuses on PROs in UC patients after treatment intensification, and hypothesize that these PROs correlate with physiological data. This is an exploratory pilot study to assess the correlation between symptoms and physiological data during treatment intensification of patients with UC in clinical practice.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Primary endpoints
PRO2 score (0 - 6) at each measurement point (day).
Heart rate variability (HRV) measures at each measurement point (day)
Key secondary outcomes
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)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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)
Key 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)
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Pauline |
| Middle name | |
| Last name | Ng |
Organization
Jansen Pharmaceutical K.K.
Division name
Medical Affairs
Zip code
101-0065
Address
3-5-2, Nishi-Kanda, Chiyoda-Ku, Tokyo
TEL
03-4411-7700
tinoue9@its.jnj.com
Public contact
Name of contact person
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Inoue |
Organization
Janssen Pharmaceutical K.K.
Division name
Medical Affairs
Zip code
101-0065
Address
3-5-2, Nishi-Kanda, Chiyoda-Ku, Tokyo
TEL
03-4411-7700
Homepage URL
tinoue9@its.jnj.com
Sponsor or person
Institute
Janssen Pharmaceutical K.K.
Institute
Department
Personal name
Funding Source
Organization
Janssen Pharmaceutical K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Fukuoka University Faculty of Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukuoka University Faculty of Medicine, Ethics Review Board
Address
7-45-1 Nanakuma, Johnan-Ku, Fukuoka 814-0180
Tel
092-801-1011
fumed-ethics@fukuoka-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
福岡大学病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 04 | Month | 22 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 24 | Day |
Date of closure to data entry
| 2024 | Year | 10 | Month | 24 | Day |
Date trial data considered complete
| 2024 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 01 | Month | 31 | Day |
Other
Other related information
This is an observational study with no control arm of prospectively followed patients with UC, who will be initiating treatment intensification. The treatment intensification is defined as initiating treatment (includes increased 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. A total of maximum 15 subjects will be planned for recruitment at a single center. Enrollment period will not be extended even if the number of subjects for analysis is achieved less than the target (15 subjects).
Subjects will be obtained informed consent, verified eligibility, and enrolled once they are planned to participate in the study. After verifying eligibility, subjects will install ActiGraph CentrePoint Connect App for periodical wearable data transmission and begin using ActiGraph LEAP device from the day of enrollment. Subjects will be asked to start wearing ActiGraph LEAP and start collecting physiological data from the date of enrollment. But physiological data collected more than 7 days prior to treatment intensification will not be used for analysis.
Subjects will also install the ePRO App, and complete baseline daily (for Day -1) and weekly (for Day -7 to -1) surveys, looking back the PROs of previous day and week, as well as demographics survey (age at the time of enrollment and sex) on the day of treatment intensification (Day 1). Thereafter, from Day 2 to the end of observational period, ePRO surveys will be continuously completed daily or weekly according to the study procedure.
Management information
Registered date
| 2024 | Year | 05 | Month | 16 | Day |
Last modified on
| 2025 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062149
