UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027320 |
|---|---|
| Receipt number | R000031301 |
| Scientific Title | Prospective Observational Study for Dual Immunosuppressant Therapy for Severe Systemic Autoimmune Diseases |
| Date of disclosure of the study information | 2017/05/22 |
| Last modified on | 2022/05/19 16:25:58 |
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Basic information
Public title
Prospective Observational Study for Dual Immunosuppressant Therapy for Severe Systemic Autoimmune Diseases
Acronym
Dual Immunosuppressant for AID (SLE-DM)
Scientific Title
Prospective Observational Study for Dual Immunosuppressant Therapy for Severe Systemic Autoimmune Diseases
Scientific Title:Acronym
Dual Immunosuppressant for AID (SLE-DM)
Region
| Japan |
Condition
Condition
1) neuropsychiatric SLE (NPSLE), 2) severe or refractory lupus nephritis (LN), 3) interstitial lung diseases complicated with dermatomyositis (DM-ILD)
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish protocols for such dual immunosuppressant therapy for patients with severe AID
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
SRI [SLE responder index] for NPSLE and severe LN, respiratory function (%VC, %DLCO) for DM-ILD at 3, 6 and 12 months
Key secondary outcomes
1) Adverse events
2) Patient survival
3) HAQ
4) SELENA-SLEDAI, PhGA, BILAG (NPSLE and severe LN)
5) Urinary protein (g/gCr) (severe LN)
6) CT findings, SpO2, P/F ratio (DM-ILD)
7) Accumulative dose of corticosteroids
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Diagnosed as NPSLE, severe LN, or DM-ILD according to the Japanese diagnostic criteria
2) In addition to corticosteroids (CS), at least 1 (dual treatment group) or one (single treatment group) of the following immunosuppressants are administrated: cyclphosphamide (CY), tacrolimus (TAC), micophanolate motetil (MMF), azathioprine (AZP), mizoribine (MZR), methotrexate (MTX), cyclosporin (CsA), hydroxychroloquine (HCQ)
3) For severe LN, to fulfill the following (1) or (2), for DM-ILD, one of the following (2)m (3), or (4)
(1) ISN/RPS classification: III, IV, V, III + V, or IV +V
(2) Resistant or refractory to CS or CS + one immunosuppressant
(3) Anti-MDA5 antibody positive
(4) Acute progression
4) Those who agreed with participating to the present study
Key exclusion criteria
1) Participation to clinical trials for other drugs within 12 wks before obtaining agreement
2) Those who received biologics, cell-depleting therapy such as rituximab, stem cell transplantation
3) Those with active infection
4) Those who were considered as inappropriate by attending physicians
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuya Atsumi |
Organization
Hokkaido University Hospital
Division name
Internal Medicine II
Zip code
Address
N15, W7, Kita-ku, Sapporo, Japan
TEL
011-706-5915
at3tat@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinsuke Yasuda |
Organization
Hokkaido University Hospital
Division name
Internal Medicine II
Zip code
Address
N15, W7, Kita-ku, Sapporo, Japan
TEL
011-706-5915
Homepage URL
syasuda@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Internal Medicine II
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 05 | Month | 22 | 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
Completed
Date of protocol fixation
| 2016 | Year | 07 | Month | 22 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 22 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 31 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Under analysis
Management information
Registered date
| 2017 | Year | 05 | Month | 12 | Day |
Last modified on
| 2022 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031301
| Research Plan | |
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| Registered date | File name |
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