UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060716 |
|---|---|
| Receipt number | R000069182 |
| Scientific Title | Survey of Difficulties and Distress Related to Physical Function and Mental Health in Patients with Rheumatoid Arthritis: A Web-Based Questionnaire Study. |
| Date of disclosure of the study information | 2026/02/24 |
| Last modified on | 2026/02/20 18:25:49 |
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Basic information
Public title
Questionnaire Survey on Physical and Mental Health in Patients with Rheumatoid Arthritis
Acronym
Questionnaire Survey on Physical and Mental Health in Patients with Rheumatoid Arthritis
Scientific Title
Survey of Difficulties and Distress Related to Physical Function and Mental Health in Patients with Rheumatoid Arthritis: A Web-Based Questionnaire Study.
Scientific Title:Acronym
Survey of Difficulties and Distress Related to Physical Function and Mental Health in Patients with Rheumatoid Arthritis: A Web-Based Questionnaire Study.
Region
| Japan |
Condition
Condition
Rheumatoid arthritis
Classification by specialty
| Clinical immunology | Geriatrics | Orthopedics |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the degree of difficulties and distress related to physical function and mental health in patients with rheumatoid arthritis and to clarify their unmet needs.
Additionally, by comparison with healthy individuals, this study aims to elucidate the extent of these difficulties among patients with rheumatoid arthritis.
Basic objectives2
Others
Basic objectives -Others
Questionnaire Study
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Difficulties and distress related to physical function and mental health in patients with rheumatoid arthritis
Key secondary outcomes
(Key secondary outcomes)
1. Difficulties and distress related to physical function and mental health in patients with rheumatoid arthritis and healthy individuals
(Exploratory outcomes)
1. Association between physical function and the degree of mental health difficulties and distress in patients with rheumatoid arthritis
2. Association between difficulties and distress across different question categories in patients with rheumatoid arthritis
3. Association between difficulties and distress across individual questionnaire items in patients with rheumatoid arthritis
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
| 30 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with Rheumatoid Arthritis
1. Patients with rheumatoid arthritis aged 30 years or older at the time of informed consent.
2. Patients who, at the time of study initiation, are registered in a disease/symptom participant panel owned by INTAGE Inc.
3. Patients who have provided written informed consent by their own will.
Healthy Participants
1. Adults aged 30 years or older at the time of informed consent.
2. Individuals who, at the time of study initiation, are registered in a general consumer panel owned by INTAGE Inc.
3. Individuals who have provided written informed consent by their own will.
Key exclusion criteria
Patients with Rheumatoid Arthritis
1.Patients who withdrew their informed consent in writing after the initiation of the study.
Healthy Participants
1. Individuals who currently have rheumatoid arthritis or have been diagnosed with rheumatoid arthritis in the past.
2. Individuals who currently have osteoarthritis or have been diagnosed with osteoarthritis in the past.
3. Individuals with a current diagnosis of cancer.
4. Individuals who have been certified as requiring long-term care.
5. Individuals who possess a physical disability certificate.
6. Individuals who withdrew their informed consent in writing after the initiation of the study.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Takumi |
| Middle name | |
| Last name | Horikawa |
Organization
ASAHI KASEI PHARMA CORPORATION
Division name
Medical Affairs Dept.
Zip code
1008440
Address
1-1-2 Yurakucho, Chiyoda-ku, Tokyo
TEL
03-6699-3655
horikawa.tf@om.asahi-kasei.co.jp
Public contact
Name of contact person
| 1st name | Takumi |
| Middle name | |
| Last name | Horikawa |
Organization
ASAHI KASEI PHARMA CORPORATION
Division name
Medical Affairs Dept.
Zip code
1008440
Address
1-1-2 Yurakucho, Chiyoda-ku, Tokyo
TEL
03-6699-3655
Homepage URL
horikawa.tf@om.asahi-kasei.co.jp
Sponsor or person
Institute
ASAHI KASEI PHARMA CORPORATION
Institute
Department
Personal name
Funding Source
Organization
ASAHI KASEI PHARMA CORPORATION
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Public Health Research Center, Public Interest Incorporated Foundation
Address
1-1-7 Nishi-Waseda, Shinjuku-ku, Tokyo, Japan
Tel
03-5287-5070
rinri@phrf.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 02 | Month | 24 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 12 | Month | 24 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 18 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 25 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1. This study is an observational study involving patients with rheumatoid arthritis and healthy individuals, and does not involve any therapeutic intervention or modification of usual medical care.
2. Participants are asked only to complete a self-administered questionnaire, and participation does not affect their routine medical care or daily life.
3. All collected data will be anonymized prior to analysis, and no personally identifiable information will be disclosed.
Management information
Registered date
| 2026 | Year | 02 | Month | 20 | Day |
Last modified on
| 2026 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069182
