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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000016844
Receipt No. R000019556
Scientific Title The clinical study for seeking strategy how to treat rheumatoid arthritis by TNF Inhibitors
Date of disclosure of the study information 2015/03/20
Last modified on 2018/07/09

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Basic information
Public title The clinical study for seeking strategy how to treat rheumatoid arthritis by TNF Inhibitors
Acronym The aggressive clinical tight control study
(TACTICS trial)
Scientific Title The clinical study for seeking strategy how to treat rheumatoid arthritis by TNF Inhibitors
Scientific Title:Acronym The aggressive clinical tight control study
(TACTICS trial)
Region
Japan

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

Objectives
Narrative objectives1 We verify induction rates of clinical remission in rheumatoid arthritis patients applied with
treatment strategies by using TNF inhibitors.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Clinical remission induction rates
Key secondary outcomes DAS28(ESR&CRP) SDAI CDAI
HAQDI
modified total sharp score

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment Pseudo-randomization

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 infliximab: standard strategy
Interventions/Control_2 infliximab: aggressive strategy
Interventions/Control_3 golimumab: standard strategy
Interventions/Control_4 golimumab: aggressive strategy
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
90 years-old >
Gender Male and Female
Key inclusion criteria Rheumatoid arthritis patients(RA) diagnosed by ACR/EULAR 2013 RA classfication criteria, and they are patients of biologics naive and inadequate response by methotrexate (MTX) therapy.
Key exclusion criteria other csDMARDs without MTX user
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Taskafumi Hagiwara
Organization Takarazuka city hospital
Division name Rheumatology
Zip code
Address Kohama4-5-1, Takarazuka city
TEL 0797-87-1161
Email college@katzenauge.sakura.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takafumi Hagiwara
Organization Takarazuka city hospital
Division name Rheumatology
Zip code
Address Kohama4-5-1, Takarazuka city
TEL 0797-87-1161
Homepage URL
Email college@katzenauge.sakura.ne.jp

Sponsor
Institute Takarazuka city hospital
Institute
Department

Funding Source
Organization Takarazuka city hospital
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 宝塚市立病院(兵庫県)

Other administrative information
Date of disclosure of the study information
2015 Year 03 Month 20 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
2014 Year 02 Month 07 Day
Date of IRB
Anticipated trial start date
2014 Year 02 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 03 Month 19 Day
Last modified on
2018 Year 07 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019556

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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