UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001818 |
|---|---|
| Receipt number | R000002173 |
| Scientific Title | A multicenter randomized controlled trial of steroid maintenance therapy for preventing relapse of autoimmune pancreatitis. |
| Date of disclosure of the study information | 2009/03/31 |
| Last modified on | 2016/11/21 11:32:47 |
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Basic information
Public title
A multicenter randomized controlled trial of steroid maintenance therapy for preventing relapse of autoimmune pancreatitis.
Acronym
A multicenter randomized controlled trial of steroid maintenance therapy for preventing relapse of autoimmune pancreatitis.
Scientific Title
A multicenter randomized controlled trial of steroid maintenance therapy for preventing relapse of autoimmune pancreatitis.
Scientific Title:Acronym
A multicenter randomized controlled trial of steroid maintenance therapy for preventing relapse of autoimmune pancreatitis.
Region
| Japan |
Condition
Condition
Autoimmune pancreatitis
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical efficacy and safety of steroid maintenance therapy for autoimmune pancreatitis after induction of remission.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
36-month relapse free rate.
Key secondary outcomes
Relapse-free duration, quality of life, and adverse events.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Continuation of steroid maintenance therapy until the 36th month from the start of remission induction therapy.
Interventions/Control_2
Discontinuation of steroid maintenance therapy at the 6th month from the start of remission induction therapy. From 7th to 36th month, closely follow-up without steroid treatment.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Diagnosed as autoimmune pancreatitis by diagnostic criteria proposed by the Japanese Pancreas Society in 2006. Without past treatment.
2) With notification of the diagnosis of autoimmune pancreatitis.
3) 20-79 years old.
4) Performance Status : 0 or 1.
5) With adequate oral intake.
6) With adequate organ functions.
7) Written informed consent.
Key exclusion criteria
1) With steroid treatment within 3 months before the start of remission induction therapy.
2) With uncontrolled infection.
3) With chronic hepatitis B or HBs antigen-positive.
4) With malignant neoplasm.
5) With severe complications.
6) Unsuitable for this clinical trial due to some complications or other critial medical phenomena.
7) Pregnant, breast-feeding, with chance of pregnancy, or expecting to give birth.
8) With severe mental disorders.
9) Judged as being unsuitable for this trial by investigators.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tooru Shimosegawa |
Organization
Tohoku University Graduate School of Medicine
Division name
Division of Gastroenterology
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8574, Japan
TEL
022-717-7171
suizo@gastroente.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Masamune |
Organization
Tohoku University Graduate School of Medicine
Division name
Division of Gastroenterology
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8574, Japan
TEL
022-717-7171
Homepage URL
suizo@gastroente.med.tohoku.ac.jp
Sponsor or person
Institute
Division of Gastroenterology, Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Kochi Medical School Hospital
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 | 03 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://gut.bmj.com/content/early/2016/08/19/gutjnl-2016-312049.long
Number of participants that the trial has enrolled
Results
Between April 2009 and March 2012, 49 patients with AIP were randomly assigned to the maintenance therapy group (n=30) or the cessation group (n=19). Baseline characteristics were not different between the two groups. Relapses occurred within 3？years in 11 out of 19 (57.9%) patients assigned to the cessation group, and in 7 of 30 (23.3%) patients in the maintenance therapy group. The relapse rate over 3？years was significantly lower in the maintenance therapy group than that in the cessation group (p=0.011). The relapse-free survival was significantly longer in the maintenance therapy group than that in the cessation group (p=0.007). No serious corticosteroid-related complications requiring discontinuation of PSL were observed.
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
| 2009 | Year | 03 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 03 | Month | 30 | Day |
Last modified on
| 2016 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002173
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
