UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042203 |
|---|---|
| Receipt number | R000048089 |
| Scientific Title | Investigation of factors affecting patients' preference of biologics treatment modes with rheumatoid arthritis |
| Date of disclosure of the study information | 2020/10/22 |
| Last modified on | 2021/06/28 12:23:16 |
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Basic information
Public title
Investigation of factors affecting patients' preference of biologics treatment modes with rheumatoid arthritis
Acronym
Investigation of factors affecting patients' preference of biologics treatment modes with rheumatoid arthritis
Scientific Title
Investigation of factors affecting patients' preference of biologics treatment modes with rheumatoid arthritis
Scientific Title:Acronym
Investigation of factors affecting patients' preference of biologics treatment modes with rheumatoid arthritis
Region
| Japan |
Condition
Condition
rheumatoid arthritis
Classification by specialty
| Clinical immunology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We conduct a web-based questionnaire survey on rheumatoid arthritis (RA) patients to clarify the background factors affecting the patients' preference of biologics treatment modes (intravenous/subcutaneous (in- hospital)/subcutaneous (self)). It will contribute to the improvement of patients' satisfaction of RA treatment over the long term.
Basic objectives2
Others
Basic objectives -Others
Factors affecting the preference of treatment modes of rheumatoid arthritis patients using biologic disease-modifying antirheumatic drugs.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Factors affecting the preference of treatment modes of rheumatoid arthritis patients using biologic disease-modifying antirheumatic drugs.
Key secondary outcomes
*Presence or absence of a gap from the current treatment modes.
*Factors which desire to change the treatment modes in the future.
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
| 20 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
*Patients with rheumatoid arthritis aged over 20 years.
*Patients who regularly visit the hospital for the treatment of rheumatoid arthritis (At least once in 3 months).
*Patients who consented via the web to participate in the present research.
Key exclusion criteria
No specific criteria
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Yamairi |
| Middle name | |
| Last name | Fumiko |
Organization
Mitsubishi Tanabe Pharma Corporation
Division name
Medical Intelligence Department
Zip code
103-8405
Address
17-10, Ninonbashi-Koamicho, Chuo-ku, Tokyo
TEL
03-6748-7738
rpp_mtpc@cc.mt-pharma.co.jp
Public contact
Name of contact person
| 1st name | Kitahara |
| Middle name | |
| Last name | Yuriko |
Organization
QLife Co., Ltd.
Division name
Medical Solution
Zip code
105-0001
Address
10th Floor, Toranomon33 Mori Bldg., 3-8-21 Toranomon, Minato-ku, Tokyo
TEL
03-6860-5020
Homepage URL
y-kitahara@qlife.co.jp
Sponsor or person
Institute
Mitsubishi Tanabe Pharma Corporation
Institute
Department
Personal name
Funding Source
Organization
Mitsubishi Tanabe Pharma Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Janssen Pharmaceutical K.K.
IRB Contact (For public release)
Organization
Medical corporation Takahashi clinic clinical trial examination committee
Address
5-1-31 Iwayakitamachi Nada-ku, Kobe-city, Hyogo
Tel
03-43662-4504
no-mori@mebix.co.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
| 2020 | Year | 10 | Month | 22 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007/s40744-021-00325-9
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s40744-021-00325-9
Number of participants that the trial has enrolled
400
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 06 | Month | 05 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 10 | Month | 13 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 23 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 02 | Day |
Date of closure to data entry
| 2020 | Year | 11 | Month | 02 | Day |
Date trial data considered complete
| 2020 | Year | 11 | Month | 24 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 18 | Day |
Other
Other related information
We conduct a web-based questionnaire survey from October 23, 2020 to November 2, 2020 for patients with rheumatoid arthritis registered in Rakuten Insight.
Management information
Registered date
| 2020 | Year | 10 | Month | 22 | Day |
Last modified on
| 2021 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048089
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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