UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003615 |
|---|---|
| Receipt number | R000004382 |
| Scientific Title | Evaluation of the effectiveness of three nonbiologic DMARDs [salazosulfapyridine(SSZ), bucillamine(BUC), methotrexate(MTX)] combination therapy for early RA |
| Date of disclosure of the study information | 2010/05/14 |
| Last modified on | 2010/05/14 18:02:54 |
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Basic information
Public title
Evaluation of the effectiveness of three nonbiologic DMARDs [salazosulfapyridine(SSZ), bucillamine(BUC), methotrexate(MTX)] combination therapy for early RA
Acronym
JANET(Japan Nonbiologic DMARDs effectiveness Trial)
Scientific Title
Evaluation of the effectiveness of three nonbiologic DMARDs [salazosulfapyridine(SSZ), bucillamine(BUC), methotrexate(MTX)] combination therapy for early RA
Scientific Title:Acronym
JANET(Japan Nonbiologic DMARDs effectiveness Trial)
Region
| Japan |
Condition
Condition
RA(Rheumatoid Arthritis)
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of three nonbiologic DMARDs (SSZ, BUC,MTX) combination therapy for early RA
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
28- tender joint count (T28),
28- swollen joint count (S28),
CRP,MMP-3,Rheumatoid ractor,Anti-CCP, antibody,ESR
GH,VAS(mm),
mHAQ
Key secondary outcomes
DAS28(ESR/CRP),
Remmision achievement rate on DAS28,
EULAR response rate,
CDAI:Clinical Disease Activity Index,
ACR 50 and 70 response rates,
Hand and foot X-ray (using modified Total Sharp Score method),
Bone density(Lumber spine or femoral neck)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Using 3 DMARDs(Salazosulfapyridine, Bucillamine, and Methotrexate) for 24 months
Interventions/Control_2
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
Patients who fulfilled the ACR and EULAR classification criteria for RA within 6 months . (Onset less than 1 year )
Key exclusion criteria
The past and complications
1)Patients with rheumatic diseases other than Sjogren's syndrome
2)Patient who has allergy in sulfa drugs
3)Patient with complications, such as the clinically signficant heart, lungs,liver and kidney disease,and blood dyscrasia
Medicine
4)Patient with the history(less than 3 months)of SSZ, BUC, and MTX use
5)Patient with the history of biological DMARDs use
6)Patient who received intra-articular steroid injection within 4 weeks before the enrollment
7)Patient treated with steroid medication(oral,intravenous,intramuscular, or rectal administration;PSL equivalent dose>5mg/day within four weeks, before the enrollment)
Operation/Treatment
8)Patient had an operation for RA within 6 months, before the enrollment
9)Patients with one of the following treatment
1 Plasma exchange
2 Leukocyte depletion therapy
3 Joint puncture and drainage for evaluated joints
Others
10)Age < 20 years old or > 80 years old
11)Prengnant or lactating patients, and patients who wish to become pregnant within three months after the enrollment. Patients who wish their partner's pregnancy by three months after the test period end which is a schedule during the test period
12)Patients whom the investigator considers to be unsuitable for the study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masato Okada |
Organization
St Luke's International Hospital
Division name
The Section of Allergy&Rheumatology
Zip code
Address
9-1,Akashi-cho,Chuou-ku,Tokyo 104-8560,Japan
TEL
03(3541)5151
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsumasa Kishimoto |
Organization
St Luke's International Hospital
Division name
The Section of Allergy&Rheumatology
Zip code
Address
TEL
03(3541)5151
Homepage URL
Sponsor or person
Institute
St Luke's International Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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
| 2010 | Year | 05 | Month | 14 | 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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 05 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 05 | Month | 14 | Day |
Last modified on
| 2010 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004382
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| Registered date | File name |
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| Registered date | File name |
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