UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003294 |
|---|---|
| Receipt number | R000003988 |
| Scientific Title | Clinical assessment of secondary AA amyloidosis associated with rheumatoid arthritis |
| Date of disclosure of the study information | 2010/03/05 |
| Last modified on | 2010/03/05 21:07:18 |
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Basic information
Public title
Clinical assessment of secondary AA amyloidosis associated with rheumatoid arthritis
Acronym
Clinical assessment of secondary AA amyloidosis associated with rheumatoid arthritis
Scientific Title
Clinical assessment of secondary AA amyloidosis associated with rheumatoid arthritis
Scientific Title:Acronym
Clinical assessment of secondary AA amyloidosis associated with rheumatoid arthritis
Region
| Japan |
Condition
Condition
rheumatoid arthritis, AA amyloidosis
Classification by specialty
| Medicine in general | Nephrology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of immunosuppressive and supportive therapies for organ failure and life prognosis, patient with RA+AA amyloidosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of disaese activity of rheumatoid arthritis, organ dysfunctions and life prognosis.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration of immunosuppressive drugs for inflammatory response of rheumatoid arthritis as long as in the absence of adverse effect.
Interventions/Control_2
Administration of anti-hypertensive drugs for hypertension as long as in the absence of adverse effect.
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
The enrolled patients have history of rheumatoid arthritis and has been diagnosed as systemic secondary AA amyloidosis by biopsy specimen.
Key exclusion criteria
These patients were excluded who has diabetic nephropathy or other proteinuric disease, and who does not have history of rheumatoid arthritis.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhito Takeda |
Organization
Aso Iizuka hospital
Division name
department of nephrology
Zip code
Address
Yoshiomachi 3-83,Iizuka,Fukuoka,Japan
TEL
0948-22-3800
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Aso Iizuka hospital
Division name
department of nephrology
Zip code
Address
Yoshiomachi 3-83,Iizuka,Fukuoka,Japan
TEL
Homepage URL
Sponsor or person
Institute
Aso Iizuka hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
| 2010 | Year | 03 | 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
| 2003 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2003 | Year | 08 | 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 | 03 | Month | 05 | Day |
Last modified on
| 2010 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003988
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
