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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000017557
Receipt No. R000020349
Scientific Title Prediction of efficacy of disease-modifying antirheumatic drugs, biologic agents and immunosupprresants for rheumatoid arthritis and collagen disease
Date of disclosure of the study information 2015/05/14
Last modified on 2015/05/14

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Basic information
Public title Prediction of efficacy of disease-modifying antirheumatic drugs, biologic agents and immunosupprresants for rheumatoid arthritis and collagen disease
Acronym Prediction of immunosuppressants
Scientific Title Prediction of efficacy of disease-modifying antirheumatic drugs, biologic agents and immunosupprresants for rheumatoid arthritis and collagen disease
Scientific Title:Acronym Prediction of immunosuppressants
Region
Japan

Condition
Condition rheumatoid arthritis, collagen disease
Classification by specialty
Medicine in general Clinical immunology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 In order to find biomarkers for predicting the clinical response
to immunosuppressants in rheumatoid arthritis and collagen diseases.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes efficacy at week 14
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients who were diagnosed with RA,
SLE, SSc, PM/DM, MCTD, Takayasu disease, GCA, PAN, GPA, MPA an EGPA according to individual international criteira.
2. Patients who will begin methotrexate, biologic agents, and immunosuppressants
Key exclusion criteria Patients who thier physicians consider as not appropriate
Target sample size 720

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsutomu Takeuchi
Organization Keio University School of Medicine
Division name Division of Rheumatology, Department of Internal Medicine
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, JAPAN
TEL 03-3353-1211
Email tsutake@z5.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuko Kaneko
Organization Keio University School of Medicine
Division name Division of Rheumatology, Department of Internal Medicine
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, JAPAN
TEL 03-3353-1211
Homepage URL
Email ykaneko@z6.keio.jp

Sponsor
Institute Keio University
Institute
Department

Funding Source
Organization Keio University
Organization
Division
Category of Funding Organization Self funding
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
2015 Year 05 Month 14 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2009 Year 11 Month 16 Day
Date of IRB
Anticipated trial start date
2009 Year 12 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To identify predictive biomarkers for efficacy and safety using mRNA, cell surface marker, or cyotkine

Management information
Registered date
2015 Year 05 Month 14 Day
Last modified on
2015 Year 05 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020349

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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