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
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
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
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
