UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028926
Receipt No. R000033103
Scientific Title Prospective cohort study for outcomes of outpatients with rheumatoid arthritis at Okayama University Hospital
Date of disclosure of the study information 2017/11/01
Last modified on 2018/09/03

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Prospective cohort study for outcomes of outpatients with rheumatoid arthritis at Okayama University Hospital
Acronym Prospective cohort study for outcomes of outpatients with rheumatoid arthritis at Okayama University Hospital (OKRA3)
Scientific Title Prospective cohort study for outcomes of outpatients with rheumatoid arthritis at Okayama University Hospital
Scientific Title:Acronym Prospective cohort study for outcomes of outpatients with rheumatoid arthritis at Okayama University Hospital (OKRA3)
Region
Japan

Condition
Condition Rheumatoid arthritis
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To elucidate factors for safety, efficacy, and adverse event in common practice for rheumatoid arthritis
Basic objectives2 Others
Basic objectives -Others Disease activity
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes DAS28 (disease activity score 28)
Key secondary outcomes Steinbrocker Stage(Joint X-Ray),CDAI,SDAI,HAQ,serum CRTN,eGFR,urine protein g/gCr, adverse event(Allergic symptoms, Digestive symptom, Interstitial pneumonia, Renal dysfunction, Liver dysfunction, Serious infections)
Fever)

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
85 years-old >
Gender Male and Female
Key inclusion criteria Patients with rheumatoid arthritis in Okayama University Hospital
Patients meet the 2010 ACR/EULAR classification criteria for the rheumatoid arthritis
Key exclusion criteria 1: Patients under 20 years or over 85 years of age at the onset
2: Patients who are judged inappropriate by attending physician
Target sample size 700

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ken-ei Sada
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name Department of Nephrology, Rheumatology, Endocrinology and Metabolism
Zip code
Address 2-5-1 Shikata-cho, Kita-ku, Okayama-city, Okayama, 700-8558
TEL 086-235-7235
Email sadakenn@okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keigo Hayashi
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name Department of Nephrology, Rheumatology, Endocrinology and Metabolism
Zip code
Address 2-5-1 Shikata-cho, Kita-ku, Okayama-city, Okayama, 700-8558
TEL 086-235-7235
Homepage URL
Email h.keigo.884@gmail.com

Sponsor
Institute Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department

Funding Source
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
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 岡山大学大学院医歯薬学総合研究科(Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences)

Other administrative information
Date of disclosure of the study information
2017 Year 11 Month 01 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 Enrolling by invitation
Date of protocol fixation
2017 Year 10 Month 24 Day
Date of IRB
Anticipated trial start date
2017 Year 11 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 Prospective cohort study
Subject)Patients with rheumatoid arthritis in Okayama University Hospital
Patients meet the 2010 ACR/EULAR classification criteria for the rheumatoid arthritis (Patients 20-84 years of age at the onset)
Evaluation item
1) To elucidate the association between primary outcome and patients characteristics and treatment by multivariate analysis.
2) To elucidate the association between secondary outcome and patients characteristics and treatment by multivariate analysis.
3) To elucidate the risk factor of renal impairment by multivariate analysis.
4) Adverse effect

Management information
Registered date
2017 Year 08 Month 31 Day
Last modified on
2018 Year 09 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033103

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.