UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036207 |
|---|---|
| Receipt number | R000041248 |
| Scientific Title | Treatment satisfaction in patients with systemic lupus erythematosus |
| Date of disclosure of the study information | 2019/04/01 |
| Last modified on | 2020/12/11 18:39:10 |
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Basic information
Public title
Treatment satisfaction in patients with systemic lupus erythematosus
Acronym
Treatment satisfaction in SLE patients
Scientific Title
Treatment satisfaction in patients with systemic lupus erythematosus
Scientific Title:Acronym
Treatment satisfaction in SLE patients
Region
| Japan |
Condition
Condition
Systemic lupus erythematosus
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Recently, hydroxychloroquine and belimumab are approved for the therapeutic agents in patients with systemic lupus erythematosus (SLE) in Japan. The aim of this study is to investigate treatment satisfaction in SLE patients treated with standard conventional agents and these newly approved drugs and to estimate factors that affect satisfaction.
Basic objectives2
Others
Basic objectives -Others
To investigate treatment satisfaction in SLE patients treated with corticosteroids, immunosuppressive agents, hydroxychloroquine, and belimumab.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of treatment satisfaction between conventional immunosuppressive agents and newly approved drugs
Key secondary outcomes
Factors affecting treatment satisfaction
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 meet 1997 Update of the American College of Rheumatology revised criteria for classification of systemic lupus erythematosus
Key exclusion criteria
Patients without therapeutic agents
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Susumu |
| Middle name | |
| Last name | Nishiyama |
Organization
Kurashiki Medical Center
Division name
Rheumatic Disease Center
Zip code
710-8522
Address
250 Bakuro-cho, Kurashiki, 710-8522
TEL
086-422-2111
s_nishiyama@fkmc.or.jp
Public contact
Name of contact person
| 1st name | Susumu |
| Middle name | |
| Last name | Nishiyama |
Organization
Kurashiki Medical Center
Division name
Rheumatic Disease Center
Zip code
710-8522
Address
250 Bakuro-cho, Kurashiki, 710-8522
TEL
086-422-2111
Homepage URL
s_nishiyama@fkmc.or.jp
Sponsor or person
Institute
Rheumatic Disease Center,
Kurashiki Medical Center
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kurashiki Medical Center
Address
250 Bakuro-cho, Kurashiki, 710-8522
Tel
086-422-2111
r_ishii@fkmc.or.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
倉敷成人病センター（岡山県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/loi/1756185x, DOI: 10.1111/1756-185X.13985
Number of participants that the trial has enrolled
40
Results
Patient satisfaction was categorized into two types: 32 of satisfied and 8 of unsatisfied. Maximum dose of CS was significantly higher in unsatisfied patients. HRQOL was significantly higher in satisfied patients.
Logistic analysis revealed satisfied patients was related to high score of HRQOL, never usage of steroid pulse, improvement in ability to remember things since taking current medication, and high score of current SLEDAI.
Results date posted
| 2020 | Year | 10 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 11 | Month | 02 | Day |
Baseline Characteristics
All patients were treated with CS. IS, HCQ, and Bel were used with CS in 13, 14, and 10 patients, respectively. Patients were classified into 4 groups, as those treated with only CS (group 1, n = 10), CS + IS +/- HCQ (group 2, n = 10), CS + HCQ (group 3, n = 10), and CS + Bel +/- IS +/- HCQ (group 4, n = 10).
Participant flow
Adverse events
None
Outcome measures
Treatment satisfaction
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 12 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 09 | Month | 14 | Day |
Date analysis concluded
| 2020 | Year | 10 | Month | 31 | Day |
Other
Other related information
Non-intervention observational study
Patients with systemic lupus erythematosus who visit our hospital from April 2019 to March 2020
Management information
Registered date
| 2019 | Year | 03 | Month | 15 | Day |
Last modified on
| 2020 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041248
| Research Plan | |
|---|---|
| Registered date | File name |
| 2019/06/24 | KMC_ethics_reference06.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
