UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002311 |
|---|---|
| Receipt number | R000002820 |
| Scientific Title | Phase II prospective treatment study for IgG4+MOLPS |
| Date of disclosure of the study information | 2009/08/10 |
| Last modified on | 2018/08/16 11:46:41 |
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Basic information
Public title
Phase II prospective treatment study for IgG4+MOLPS
Acronym
IgG4 prospective treatment study
Scientific Title
Phase II prospective treatment study for IgG4+MOLPS
Scientific Title:Acronym
IgG4 prospective treatment study
Region
| Japan |
Condition
Condition
IgG4+MOLPS (IgG4+Multiorgan lymphoproliferative syndrome)
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Cardiology | Pneumology | Endocrinology and Metabolism |
| Hematology and clinical oncology | Nephrology | Neurology |
| Clinical immunology | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Vascular surgery | Chest surgery | Endocrine surgery |
| Breast surgery | Ophthalmology | Oto-rhino-laryngology |
| Urology | Oral surgery |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
For making the diagnostic criteria and treatment guidline of IgG4+MOLPS.
Basic objectives2
Others
Basic objectives -Others
For searching novel serological, genetical or histological markers.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
CR rate
Key secondary outcomes
Maintenance dose of steroid, relapse rate, adverse effects
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Initial dose of prednisolone 0.6mg/kg/day. Taper prednisolone every 2 weeks 10%, and maintenance dose 10mg/day at least 3 months.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1, IgG4+MOLPS
2, age more than 19 yrs
3, written informed consent
Key exclusion criteria
1, Castleman disease, Wegener granulomatosis, Sarcoidosis, cancer lymphoma, and other distinct disorders.
2, severe infectious disease
3, pre-treatment of steroid or immuno-suppressive drugs
4, physician's decision
Target sample size
57
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasufumi Masaki |
Organization
Kanazawa Medical University
Division name
Hematology and Immunology
Zip code
Address
1-1 Daigaku, Uchinada, kahoku-gun, Ishikawa
TEL
076-286-3511
yasum@kanazawa-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasufumi Masaki |
Organization
Kanazawa Medical University
Division name
Hematology and Immunology
Zip code
Address
1-1 Daigaku, Uchinada, kahoku-gun, Ishikawa
TEL
076-286-3511
Homepage URL
http://www.kanazawa-med.ac.jp/~hematol/topics4.html
yasum@kanazawa-med.ac.jp
Sponsor or person
Institute
Department of Hematology and Immunology,
Kanazawa Medical University
Institute
Department
Personal name
Funding Source
Organization
IgG4+MOLPS research group, Japan
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
| 2009 | Year | 08 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/27846767
Number of participants that the trial has enrolled
Results
RESULTS:
This study enrolled 61 patients. After clinicopathological review, three patients were excluded, and one, 13, and 44 patients were diagnosed with probable, possible, and definite IgG4-related disease, respectively. Of the 44 patients with definite IgG4-RD, 29 (65.9%) achieved CR, and the ORR was 93.2%. No patient was refractory to primary treatment. The most frequent adverse events were glucose intolerance. Six patients relapsed.
CONCLUSIONS:
Glucocorticoid treatment is usually effective for patients with IgG4-RD, and we should examine the possibility of other disorders when a patient is glucocorticoid refractory. Some patients are misdiagnosed, making central clinicopathological review of diagnosis very important in conducting clinical studies.
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
Main results already published
Date of protocol fixation
| 2009 | Year | 06 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2018 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2018 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2018 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 08 | Month | 09 | Day |
Last modified on
| 2018 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002820
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2018/08/16 | A multicenter phase II prospective clinical trial of glucocorticoid for patients with untreated IgG4 related disease.pdf |
