UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective cohort study for outcomes of outpatients with rheumatoid arthritis at Okayama University Hospital
Title of the study (Brief title)	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	Ken-ei Sada
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name	Department of Nephrology, Rheumatology, Endocrinology and Metabolism
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	Keigo Hayashi
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name	Department of Nephrology, Rheumatology, Endocrinology and Metabolism
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 10 Month 24 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000033103