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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003869
Receipt No. 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 2017/01/09

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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
Middle name
Last name Noboru Suzuki
Organization St. Marianna University School of Medicine
Division name Institute of Medical Science St. Marianna Univ. School of Medicine
Zip code
Address Sugao 2-16-1, Miyamae-ku, Kawasaki-shi, 216-8511, Japan
TEL 044-977-8111
Email n3suzuki@marianna-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Jun Shimizu
Organization St. Marianna University School of Medicine
Division name Department of Immunology and Medicine
Zip code
Address Sugao 2-16-1, Miyamae-ku, Kawasaki-shi, 216-8511, Japan
TEL 044-977-8111
Homepage URL
Email jshimizu@marianna-u.ac.jp

Sponsor
Institute St. Marianna University School of Medicine
Institute
Department

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
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
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
Anticipated trial start date
2010 Year 07 Month 01 Day
Last follow-up date
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
2017 Year 01 Month 09 Day


Link to view the page
URL(English) https://upload.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


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