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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025537
Receipt No. 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 2018/04/09

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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
Middle name
Last name Takafumi Hagiwara
Organization Takarazuka city hospital
Division name Division of rheumatology
Zip code
Address Kohama 4-5-1, Takarazuka city
TEL 0797-87-1161
Email college@katzeneuga.sakura.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takafumi Hagiwara
Organization Takarazuka City Hospital
Division name Division of Rheumatology
Zip code
Address kohama 4-5-1, Takarazuka city.
TEL 0797-87-1161
Homepage URL
Email thagiwara-college@umin.ac.jp

Sponsor
Institute Division of Rheumatology, Takarazuka City Hospital.
Institute
Department

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
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
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
Anticipated trial start date
2017 Year 01 Month 06 Day
Last follow-up date
2020 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
2018 Year 04 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029392

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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