UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050368 |
|---|---|
| Receipt number | R000057314 |
| Scientific Title | A Quantitative Study of Patients with Systemic Sclerosis |
| Date of disclosure of the study information | 2023/02/24 |
| Last modified on | 2025/02/28 13:36:04 |
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Basic information
Public title
A Quantitative Study of Patients with Systemic Sclerosis
Acronym
SSc Surveys
Scientific Title
A Quantitative Study of Patients with Systemic Sclerosis
Scientific Title:Acronym
A Quantitative Study of Patients with Systemic Sclerosis
Region
| Japan |
Condition
Condition
Systemic Sclerosis
Classification by specialty
| Clinical immunology | Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the reality of systemic sclerosis treatment.
Basic objectives2
Others
Basic objectives -Others
To clarify the characteristics of pain associated with systemic sclerosis and to find treatment gaps between patients and physicians.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
SF-MPQ-2 score
Factors related to pain
Treatment gaps between patients and physicians
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients :
1)Patients aged 18 years or older.
2)Patients diagnosed with systemic sclerosis.
3)Patients who signed informed consent form.
Physicians:
1)The number of beds in the clinic or hospital is 20 or more.
2)Physicians who see at least 3 patients with systemic sclerosis per month.
3)Physicians who signed informed consent form.
Key exclusion criteria
Not applicable
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Yasumasa |
| Middle name | |
| Last name | Kanai |
Organization
Kyowa Kirin Co., Ltd.
Division name
Medical Affairs
Zip code
100-0004
Address
1-9-2, Otemachi, Chiyoda-ku, Tokyo
TEL
03-5205-7200
ma.immunology_2g.xw@kyowakirin.com
Public contact
Name of contact person
| 1st name | Yasumasa |
| Middle name | |
| Last name | Kanai |
Organization
Kyowa Kirin Co., Ltd.
Division name
Medical Affairs
Zip code
100-0004
Address
1-9-2, Otemachi, Chiyoda-ku, Tokyo
TEL
03-5205-7200
Homepage URL
ma.immunology_2g.xw@kyowakirin.com
Sponsor or person
Institute
Kyowa Kirin Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Kyowa Kirin Co., Ltd.
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
Research Ethical Review Committee of Kyowa Kirin Co., Ltd
Address
1-9-2, Otemachi, Chiyoda-ku, Tokyo 100-0004, JAPAN
Tel
03-5205-7200
researchethics.fj@kyowakirin.com
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
| 2023 | Year | 02 | Month | 24 | Day |
Related information
URL releasing protocol
Not open to the public
Publication of results
Partially published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/39907912/
Number of participants that the trial has enrolled
431
Results
Patients with intermittent chest, head, and neck pain had higher pain scores. Patients with nausea, insomnia, and pain symptoms had particularly high pain scores. Patients felt that their pain was not as responsive to treatment as their doctors thought. Physicians did not recognize fatigue, which many patients felt was a painful symptom, as a painful symptom. There were differences in physicians' and patients' perceptions of the motivation for treating pulmonary symptoms.
Results date posted
| 2025 | Year | 02 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 02 | Month | 05 | Day |
Baseline Characteristics
Data from 301 patients and 129 physicians who completed the questionnaire were analyzed. In the patient group (n=301), responses were provided directly by 216 patients (71.8%) and by 85 patients' representatives (28.2%). Most patients (264, 87.7%) were aged 30-80 years, with the highest patient proportion occurring in the range of 50-60 years (27.6% [83 patients]). Overall, 63.8% (192 patients) reported they were female, and 34.6% (104 patients) were male. Of all 301 patients, 37.9% (114 patients) had a disease duration of >5 years, followed by 20.3% (61 patients) with 1-3 years and 15.3% (46 patients) with 3-5 years in duration. Regarding the disease type classification, 143 patients had lcSSc (47.5%) and 135 had dcSSc (44.9%). The most common SSc-related autoantibodies were anti-centromere antibodies (32.6% [98 patients]), followed by anti-topoisomerase I (Scl-70) antibodies (30.6% [92 patients]), and anti-RNA polymerase III antibodies (22.6% [68 patients]). The most common departments patients consulted with were Dermatology (61.8% [186 patients]) and Rheumatology (44.5% [134 patients]), with some patients visiting both.
Participant flow
Leaflets with the survey Internet address were distributed to patients registered as having "SSc" in the Patients Association for Collagen Vascular Diseases Japan database (Tokyo, Japan). Additionally, an announcement containing the survey's Internet address was posted within the Systemic Sclerosis Patient Community group on the "LINE Open Chat", an online social platform within the LINE mobile messaging application by LY Corporation (Tokyo, Japan) and operated by QLife, Inc. (Tokyo, Japan). An invitation with the survey Internet address was also sent along with the QLife, Inc. newsletter to all those who were subscribed. To obtain responses from physicians, the questionnaire was sent to the m3.com magazine e-mail subscription database (M3, Inc., Tokyo, Japan).
Adverse events
No report
Outcome measures
SF-MPQ-2 score
Factors related to pain
Treatment gaps between patients and physicians
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2023 | Year | 02 | Month | 08 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 16 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 09 | Month | 18 | Day |
Date analysis concluded
| 2023 | Year | 12 | Month | 15 | Day |
Other
Other related information
A web-based survey targeting physicians who see patients with systemic sclerosis and patients diagnosed with systemic sclerosis
Management information
Registered date
| 2023 | Year | 02 | Month | 17 | Day |
Last modified on
| 2025 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057314
