UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003869 |
|---|---|
| Receipt number | R000004656 |
| Scientific Title | A clinical study to establish in diagnostic criteria and treatment guideline of relapsing polychondritis. |
| Date of disclosure of the study information | 2010/07/05 |
| Last modified on | 2020/01/11 11:31:37 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A clinical study to establish in diagnostic criteria and treatment guideline of relapsing polychondritis.
Acronym
Diagnostic and treatment guideline of relapsing polychondritis
Scientific Title
A clinical study to establish in diagnostic criteria and treatment guideline of relapsing polychondritis.
Scientific Title:Acronym
Diagnostic and treatment guideline of relapsing polychondritis
Region
| Japan |
Condition
Condition
Relapsing polychondritis
Classification by specialty
| Pneumology | Clinical immunology | Chest surgery |
| Dermatology | Oto-rhino-laryngology | Orthopedics |
| Radiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Relapsing polychondritis is an uncommon, chronic disorder of the cartilage that is characterized by recurrent episodes of inflammation of the cartilage of various tissues of the body.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
responce rate in tresatment with corticosteroid and immunosuppressants for 12 months
Key secondary outcomes
OS: overall survival
DCR: disease control rate
AE: Adverse events
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
corticosteroid+methotrexate
Interventions/Control_2
corticosteroid+ciclosporin
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
Patients are going to be treated with an immunosuppresant under corticosteroid therapy.
Key exclusion criteria
(1) Patients are thought to require an admission.
(2) Patients with severe complications as diabetes mellitus, heart disease, chronic infections or cancers.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Noboru |
| Middle name | |
| Last name | Suzuki |
Organization
St. Marianna University School of Medicine
Division name
Institute of Medical Science St. Marianna Univ. School of Medicine
Zip code
216-8511
Address
Sugao 2-16-1, Miyamae-ku, Kawasaki-shi, 216-8511, Japan
TEL
044-977-8111
n3suzuki@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Shimizu |
Organization
St. Marianna University School of Medicine
Division name
Department of Immunology and Medicine
Zip code
216-8511
Address
Sugao 2-16-1, Miyamae-ku, Kawasaki-shi, 216-8511, Japan
TEL
044-977-8111
Homepage URL
jshimizu@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
MHLW (Japan)
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
St. Marianna University School of Medicine
Address
Sugao 2-16-1, Miyamae-ku, Kawasaki-shi, 216-8511, Japan
Tel
044-977-8111
k-sienbu.mail@marianna-u.ac.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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 07 | Month | 05 | 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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 09 | Month | 05 | Day |
Anticipated trial start date
| 2010 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2035 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 07 | Month | 05 | Day |
Last modified on
| 2020 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004656
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
