UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012916 |
|---|---|
| Receipt number | R000015021 |
| Scientific Title | Analysis of immune status in autoimmune diseases treated with Biologics |
| Date of disclosure of the study information | 2014/01/21 |
| Last modified on | 2014/01/21 22:40:30 |
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Basic information
Public title
Analysis of immune status in autoimmune diseases treated with Biologics
Acronym
Analysis of immune status in autoimmune diseases treated with Biologics
Scientific Title
Analysis of immune status in autoimmune diseases treated with Biologics
Scientific Title:Acronym
Analysis of immune status in autoimmune diseases treated with Biologics
Region
| Japan |
Condition
Condition
Autoimmune diseases
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze the changes of immune status in the patients with autoimmune diseases being treated with biologics.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase IV
Assessment
Primary outcomes
Biomarkers in sera and the surface markers on peripheral blood cells mRNA of
disease related molecules were analyzed by ELISA,FACS and RT-PCR in autoimmune
diseases treated with biologics
Key secondary outcomes
To evaluate efficacy of Biologics
-clinical assessment;DAS 28,High sensitivity C-reactive protein etc.
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Biologics
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Males and Females diagnosed rheumatoid arthritis must
-be more than 20 years old
-be informed and will give written informed consent
Key exclusion criteria
-Complicated with active infectious disease
-The Petients who the doctors in charge
consider should not enter this study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Ogata |
Organization
Osaka University
Division name
Department of Respiratory Medicine, Allergy and Rheumatic Disease
Zip code
Address
2-2 Yamadaoka,Suita,Osaka 565-0871
TEL
06-6879-3833
ogata@imed3.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Ogata |
Organization
Osaka University
Division name
Department of Respiratory Medicine, Allergy and Rheumatic Disease
Zip code
Address
2-2 Yamadaoka,Suita,Osaka 565-0871
TEL
06-6879-3833
Homepage URL
ogata@imed3.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
Osaka 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
大阪大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 01 | Month | 21 | 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
Completed
Date of protocol fixation
| 2008 | Year | 08 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2013 | Year | 01 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 01 | Month | 21 | Day |
Last modified on
| 2014 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015021
