UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016844 |
|---|---|
| Receipt number | 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 | 2023/03/27 09:21:50 |
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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 | Takafumi |
| Middle name | |
| Last name | Hagiwara |
Organization
Takarazuka city hospital
Division name
Rheumatology
Zip code
665-0827
Address
Kohama4-5-1, Takarazuka city
TEL
0797-87-1161
college@katzenauge.sakura.ne.jp
Public contact
Name of contact person
| 1st name | Takafumi |
| Middle name | |
| Last name | Hagiwara |
Organization
Takarazuka city hospital
Division name
Rheumatology
Zip code
665-0827
Address
Kohama4-5-1, Takarazuka city
TEL
0797-87-1161
Homepage URL
college@katzenauge.sakura.ne.jp
Sponsor or person
Institute
Takarazuka city hospital
Institute
Department
Personal name
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
Takarazuka City Hospital
Address
Kohama4-5-1, Takarazuka city
Tel
0797-87-1161
takarazukarinken@jcom.zaq.ne.jp
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
| 2014 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2014 | Year | 02 | Month | 07 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
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
| 2023 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019556
