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 | 2025/08/13 15:39:54 |
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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 | Yoshiya |
| Middle name | |
| Last name | Tanaka |
Organization
School of Medicine, University of Occupational and Environmental Health, Japan
Division name
First Department of Internal Medicine
Zip code
807-8555
Address
1-1, Iseigaoka, Yahata-nishi-ku, Kitakyushu, 807-8555, Japan
TEL
093-603-1611
tanaka@med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuyoshi |
| Middle name | |
| Last name | Saito |
Organization
School of Medicine, University of Occupational and Environmental Health, Japan
Division name
First Department of Internal Medicine
Zip code
807-8555
Address
1-1, Iseigaoka, Yahata-nishi-ku, Kitakyushu, 807-8555, Japan
TEL
093-603-1611
Homepage URL
kazu-s@med.uoeh-u.ac.jp
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
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Medical Research,University of Occupational and Environmental Health,Japan
Address
1-1 Iseigaoka, Yahatanishiku, Kitakyushu
Tel
093-603-1611
daigakukanri@mbox.pub.uoeh-u.ac.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
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 07 | Month | 31 | Day |
Related information
URL releasing protocol
https://mhlw-grants.niph.go.jp/project/24918
Publication of results
Partially published
Result
URL related to results and publications
https://mhlw-grants.niph.go.jp/project/24918
Number of participants that the trial has enrolled
162
Results
Of 162 patients, 81 with early RA were analyzed. After 3 months of MTX, 31 achieved low disease activity; 32 switched to TNF inhibitors, and 18 continued MTX. One-year DAS28 improved from 4.2 to 3.5 with MTX and 5.0 to 2.9 with TNF inhibitors. Delta mTSS was 1.4 vs -0.1 (65.6% structural remission), and remained 1.6 even with initial MTX response, indicating incomplete prevention of joint damage.
Results date posted
| 2025 | Year | 08 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Meets the 2010 ACR/EULAR classification criteria for rheumatoid arthritis, is positive for anti-CCP antibodies, has a disease duration of <=2 years, and has three or fewer bone erosions on hand and foot radiographs.
Participant flow
Treatment was initiated with methotrexate (6-16 mg/week), and therapeutic efficacy was assessed at 12 weeks. Patients who met the JCR guideline criteria for TNF inhibitor initiation and provided consent received TNF inhibitors, while those who did not consent continued MTX. Patients who did not meet the JCR guideline criteria for TNF inhibitor initiation also continued MTX.
Adverse events
Safety analysis was conducted based on the safety population, which included all patients who enrolled inthe study and received MTX at least once.
Outcome measures
Bone destruction was assessed using the modified Sharp method at three time points: at the initial visit (MTX initiation), at the start of TNF inhibitor therapy (or when TNF inhibitor therapy was declined), and at one year after initiation (week 54).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2008 | Year | 07 | Month | 16 | Day |
Date of IRB
| 2008 | Year | 07 | Month | 15 | Day |
Anticipated trial start date
| 2008 | Year | 07 | Month | 16 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 09 | Month | 30 | Day |
Other
Other related information
none
Management information
Registered date
| 2008 | Year | 07 | Month | 31 | Day |
Last modified on
| 2025 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001560
