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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000002311
Receipt No. 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

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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
Email 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
Email yasum@kanazawa-med.ac.jp

Sponsor
Institute Department of Hematology and Immunology,
Kanazawa Medical University
Institute
Department

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
Email

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
URL(English) https://upload.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


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