UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025537 |
|---|---|
| Receipt number | R000029392 |
| Scientific Title | Examination of the epidemiology investigation in the rheumatoid arthritis new onset patient |
| Date of disclosure of the study information | 2017/01/06 |
| Last modified on | 2023/01/10 12:38:07 |
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Basic information
Public title
Examination of the epidemiology investigation in the rheumatoid arthritis new onset patient
Acronym
Examination of the epidemiology investigation in the rheumatoid arthritis new onset patient
Scientific Title
Examination of the epidemiology investigation in the rheumatoid arthritis new onset patient
Scientific Title:Acronym
Examination of the epidemiology investigation in the rheumatoid arthritis new onset patient
Region
| Japan |
Condition
Condition
Rheumatoid arthritis
Classification by specialty
| Medicine in general | Clinical immunology | Orthopedics |
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We observe risk factors possession rate at the time of the rheumatoid arthritis onset and examine the odds ratio of risk factors.
Basic objectives2
Others
Basic objectives -Others
Examination of the influence that a rheumatoid arthritis onset risk factor gives in an episode of care.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Possession rate of antibodies and their titer, such as rheumatoid factor, anti-SSA/Ro antibody and anti- cyclic citrullinated peptide antibody in non-treatment after the rheumatoid arthritis onset. And possession rate of risk factors (ex; gender, smoking habit, periodontitis, bronchitis and interstitial pneumonitis) in conjunction with these antibody instructions.
Key secondary outcomes
Evaluation of the influence that antibodies and an antibody instruction risks give in an episode of care of the rheumatoid arthritis (as follows)
1) Disease activity scores (Week 0, 24, 52)
2) Functional assessment with HAQDI (week 0, 24, 52)
3) Radiographic assessment (Week 0, 24, 52)
4) Possession rates of bronchitis and interstitial penumonitis (Week 0, 52) with chest CT and measurement of vital capacity by a spirometer and flow-volume curve, carbon monoxide lung diffusing capacity.
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
| 20 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with rheumatoid arthritis onset.
Key exclusion criteria
Patients with rheumatoid arthritis received some kind of treatments with DMARD.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hagiwara |
| Middle name | |
| Last name | Hagiwara |
Organization
Takarazuka city hospital
Division name
Division of rheumatology
Zip code
665-0827
Address
Kohama 4-5-1, Takarazuka city
TEL
0797-87-1161
college@katzeneuga.sakura.ne.jp
Public contact
Name of contact person
| 1st name | Takafumi |
| Middle name | |
| Last name | Hagiwara |
Organization
Takarazuka City Hospital
Division name
Division of Rheumatology
Zip code
665-0827
Address
kohama 4-5-1, Takarazuka city.
TEL
0797-87-1161
Homepage URL
thagiwara-college@umin.ac.jp
Sponsor or person
Institute
Division of Rheumatology, Takarazuka City Hospital.
Institute
Department
Personal name
Funding Source
Organization
Self funding.
Takarazuka City Hospital.
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
Takarazuka City hospital
Address
Kohama 4-5-1, Takarazuka city, Japan.
Tel
0797-87-1161
takarazukarinken@jcom.zaq.ne.jp
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
| 2017 | Year | 01 | Month | 06 | 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
| 2016 | Year | 12 | Month | 14 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 02 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1)Blood (ACPA, RF, ANA, anti-SSA/Ro antibody, IgG, CRP, ESR, MMP-3, KL-6)
2) Disease activity scores
3) Functional assessment with HAQDI
4) Radiographic assessment (Hands and feet x-ray)
5) Chest CT
6) Measurement of vital capacity by a spirometer and flow-volume curve, carbon monoxide lung diffusing capacity.
Management information
Registered date
| 2017 | Year | 01 | Month | 05 | Day |
Last modified on
| 2023 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029392
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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