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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002169
Receipt No. R000002652
Scientific Title Safety and efficacy of 3 DMARDs for 2 years of treatment in patients with early rheumatoid arthritis
Date of disclosure of the study information 2009/07/07
Last modified on 2015/02/04

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Basic information
Public title Safety and efficacy of 3 DMARDs for 2 years of treatment in patients with early rheumatoid arthritis
Acronym TRED study
Scientific Title Safety and efficacy of 3 DMARDs for 2 years of treatment in patients with early rheumatoid arthritis
Scientific Title:Acronym TRED study
Region
Japan

Condition
Condition Rheumatoid Arthritis
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Usefulness
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase IV

Assessment
Primary outcomes DAS
Key secondary outcomes remisshion

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Salazosulfapyridine
Interventions/Control_2 Bucillamine
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
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria Rheumatoid Arthritis within 1-year
Key exclusion criteria Autoimmuno disease without RA
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Seizo Yamana
Organization Higashi-Hiroshima Memorial Hospital
Division name Director
Zip code
Address 2214, Yosiyuki, saijo-chou, Higasihirosima-city, Hirosima, 739-0002, Japan
TEL 082-423-6661
Email

Public contact
Name of contact person
1st name
Middle name
Last name Mitsuhiro Iwahasi
Organization Director
Division name RA center
Zip code
Address 2214, Yosiyuki, saijo-chou, Higasihirosima-city, Hirosima, 739-0002, Japan
TEL 082-423-6661
Homepage URL
Email

Sponsor
Institute Higashi-Hiroshima Memorial Hospital
Institute
Department

Funding Source
Organization Santen Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor none
Name of secondary funder(s) none

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
2009 Year 07 Month 07 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2009 Year 06 Month 24 Day
Date of IRB
Anticipated trial start date
2009 Year 07 Month 01 Day
Last follow-up date
2013 Year 03 Month 31 Day
Date of closure to data entry
2013 Year 08 Month 31 Day
Date trial data considered complete
2013 Year 09 Month 30 Day
Date analysis concluded
2013 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2009 Year 07 Month 07 Day
Last modified on
2015 Year 02 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002652

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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