UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Longitudinal study about the impact of treatment with tumor necrosis factor (TNF) inhibitors on tuberculin skin test (TST) reaction in patients with rheumatoid arthritis (RA).
Title of the study (Brief title)	Longitudinal study about the impact of monoclonal antibody to TNF treatment on TST reaction in patients with RA in Jichi medical university.
Region	Japan

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

Objectives
Narrative objectives1	To examine whether TNF inhibitors suppress TST reaction or not in patients with RA.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	TST in patients with RA before and one or more years after the introduction of the treatment with TNF inhibitors.
Key secondary outcomes

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	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Adult patients with RA who had been treated with infliximab or etanercept for more than a year.
Key exclusion criteria	Patients who are pregnant, breast-feed, and desire to be pregnant.
Target sample size	100

Research contact person
Name of lead principal investigator	Katsuya Nagatani
Organization	Jichi Medical University
Division name	Division of Rheumatology and Clinical Immunology, Department of Medicine
Address	3311-1 Yakushiji, Shimotsuke-shi, Tochigi 329-0498, JAPAN
TEL	0285-58-7358
Email	knagatani@jichi.ac.jp

Public contact
Name of contact person	Katsuya Nagatani
Organization	Jichi Medical University
Division name	Division of Rheumatology and Clinical Immunology, Department of Medicine
Address	3311-1 Yakushiji, Shimotsuke-shi, Tochigi 329-0498, JAPAN
TEL	0285-58-7358
Homepage URL
Email	knagatani@jichi.ac.jp

Sponsor
Institute	Jichi Medical University
Institute
Department

Funding Source
Organization	Jichi Medical University
Organization
Division
Category of Funding Organization	Other
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

Other administrative information
Date of disclosure of the study information	2016 Year 02 Month 16 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2008 Year 09 Month 01 Day
Anticipated trial start date	2008 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete	2018 Year 02 Month 16 Day
Date analysis concluded	2018 Year 02 Month 16 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/pubmed/28524434
Results
Other related information	This longitudinal study was performed to compare the tuberculin skin test (TST) reaction before and after initiation of therapy with TNF inhibitors. Adult RA patients attending the Division of Rheumatology and Clinical Immunology of Jichi Medical University Hospital between 2008 and 2009 who had been treated with infliximab or etanercept for longer than 1 year gave informed consent to this study.

Management information
Registered date	2016 Year 02 Month 16 Day
Last modified on	2018 Year 02 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024290