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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036207
Receipt No. 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

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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
Email 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
Email s_nishiyama@fkmc.or.jp

Sponsor
Institute Rheumatic Disease Center,
Kurashiki Medical Center
Institute
Department

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
Email 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
URL(English) https://upload.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


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