UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021048
Receipt number R000024290
Scientific Title 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).
Date of disclosure of the study information 2016/02/16
Last modified on 2018/02/16 18:08:47

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Basic information

Public title

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).

Acronym

Longitudinal study about the impact of monoclonal antibody to TNF treatment on TST reaction in patients with RA in Jichi medical university.

Scientific Title

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).

Scientific Title:Acronym

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

1st name
Middle name
Last name Katsuya Nagatani

Organization

Jichi Medical University

Division name

Division of Rheumatology and Clinical Immunology, Department of Medicine

Zip code


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

1st name
Middle name
Last name Katsuya Nagatani

Organization

Jichi Medical University

Division name

Division of Rheumatology and Clinical Immunology, Department of Medicine

Zip code


Address

3311-1 Yakushiji, Shimotsuke-shi, Tochigi 329-0498, JAPAN

TEL

0285-58-7358

Homepage URL


Email

knagatani@jichi.ac.jp


Sponsor or person

Institute

Jichi Medical University

Institute

Department

Personal name



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)



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

2016 Year 02 Month 16 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

https://www.ncbi.nlm.nih.gov/pubmed/28524434

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

Completed

Date of protocol fixation

2008 Year 09 Month 01 Day

Date of IRB


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


Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024290


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name