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Recruitment status
Unique ID issued by UMIN UMIN000001281
Receipt No. R000001560
Scientific Title Strategic reduction of joint destruction in rheumatoid arthritis
Date of disclosure of the study information 2008/07/31
Last modified on 2012/01/31

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Basic information
Public title Strategic reduction of joint destruction in rheumatoid arthritis
Acronym Strategic reduction of joint destruction in rheumatoid arthritis (ZERO-J study)
Scientific Title Strategic reduction of joint destruction in rheumatoid arthritis
Scientific Title:Acronym Strategic reduction of joint destruction in rheumatoid arthritis (ZERO-J study)
Region
Japan

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

Objectives
Narrative objectives1 To confirm the strategic treatment guideline in order to reduce and stop joint destruction in rheumatoid arthritis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparison of reduction of joint destruction between TNF-inhibitors and MTX alone.
Key secondary outcomes (1) new bone erosion
(2) DAS28
(3) EULAR-improvement criteria
(4) HAQ

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 TNF-inhibitors plus MTX
TNF-inhibitors are used for 54 weeks and exchange among them is approved
Interventions/Control_2 MTX
MTX is used for 54 weeks and addition of the other DMARD is approved
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who meet all of the following criteria will be enrolled in this study:
1) Patients with RA diagnosed according to the criteria of the American College of Rheumatology (ACR) (1987)
2) Patients who develop develop moderate or high activity, despite NSAID and/or DMARD therapy
3) Patients who agreed to practice an appropriate contraception during the study period
Key exclusion criteria Patients who met the following criteria are excluded.
1. patients with contra-indication to MTX
2. patients with contra-indication to TNF-inhibitors
3. patients who are not appropriate to the study by a doctor's judgement
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiya Tanaka
Organization School of Medicine, University of Occupational and Environmental Health, Japan
Division name First Department of Internal Medicine
Zip code
Address 1-1, Iseigaoka, Yahata-nishi-ku, Kitakyushu, 807-8555, Japan
TEL 093-603-1611
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kazuyoshi Saito
Organization School of Medicine, University of Occupational and Environmental Health, Japan
Division name First Department of Internal Medicine
Zip code
Address 1-1, Iseigaoka, Yahata-nishi-ku, Kitakyushu, 807-8555, Japan
TEL 093-603-1611
Homepage URL
Email

Sponsor
Institute School of Medicine, University of Occupational and Environmental Health, Japan
Institute
Department

Funding Source
Organization a Research Grant-In-Aid for Scientific Research from the Ministry of Health, Labor and Welfare of Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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
2008 Year 07 Month 31 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
Date of protocol fixation
2008 Year 07 Month 16 Day
Date of IRB
Anticipated trial start date
2008 Year 07 Month 01 Day
Last follow-up date
2011 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2008 Year 07 Month 31 Day
Last modified on
2012 Year 01 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001560

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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