UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017557 |
|---|---|
| Receipt number | 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 12:18:46 |
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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
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
ykaneko@z6.keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020349
