UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001281 |
|---|---|
| Receipt number | 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 11:52:58 |
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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
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
Sponsor or person
Institute
School of Medicine, University of Occupational and Environmental Health, Japan
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001560
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
