UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003807 |
|---|---|
| Receipt number | R000004587 |
| Scientific Title | A study for comparison of triple combination therapy (bucillamine, salazosulphapiridine and methotrexate) with TNF-blocking biologics and methotrexate combination therapy concerning efficacy and tolerability for rheumatoid arthritis |
| Date of disclosure of the study information | 2010/07/01 |
| Last modified on | 2017/12/28 08:43:39 |
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Basic information
Public title
A study for comparison of triple combination therapy (bucillamine, salazosulphapiridine and methotrexate) with TNF-blocking biologics and methotrexate combination therapy concerning efficacy and tolerability for rheumatoid arthritis
Acronym
JaSTAR Study
Scientific Title
A study for comparison of triple combination therapy (bucillamine, salazosulphapiridine and methotrexate) with TNF-blocking biologics and methotrexate combination therapy concerning efficacy and tolerability for rheumatoid arthritis
Scientific Title:Acronym
JaSTAR Study
Region
| Japan |
Condition
Condition
Rheumatoid Arthritis
Classification by specialty
| Clinical immunology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
comparison of triple combination therapy (bucillamine, salazosulphapiridine and methotrexate) with TNF-blocking biologics and methotrexate combination therapy concerning efficacy and tolerability for rheumatoid arthritis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The mean of DAS28 at 6 and 12 months after initiation of treatment
Key secondary outcomes
The change in modified Sharp Score from base-line at 12 months after initiation of treatment
Percentage of patients which achieved functional remission (mHAQ<0.5) at 3, 6 and 12 months after initiation of treatment
Percentage of patients which achieved clinical remission (DAS28<2.6) at 3, 6 and 12 months after initiation of treatment
The mean of CDAI at 3,6 and 12 months after initiation of treatment
The mean of MMP-3 at 3,6 and 12 months after initiation of treatment
The cost-effectiveness at 12 months after initiation of treatment
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is 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
Combination therapy of three DMARDs (bucillamine, salazosulphapyridine and methotrexate)
Interventions/Control_2
Combination therapy of TNF-bloking biologics and methotrexate
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
1.Patients, fulfilled the ACR 1987 revised criteria for the classification of theumatoid arthritis
2.Patients who had disease activity (DAS28>3.2), despite of treatment with bucillamin, salazosulphapyridine, methotrexate or combination of two of them
3.Patients who had not received the treatment with biologics
4.Patients who can provide written informed concent by themselves
Key exclusion criteria
(Complication)
Patients who had any of the following diagnoses or medical history:
1) Autoimmune disease except for Sjogren syndorome, and malignancy
2) Drug allergy
3) Severe heart, lung, liver. kidney and hematolodical disorders
(Treatment)
4)Patient who recived intramuscular, intoravenous or epidural injection of corticosteroids within 4 weeks prior to the entry or during study
5)Patient who recived intraarticular corticosteroid at dose of over 20mg/month of prednisolone, and patients who recieved intraarticular corticosteroid at any dose within 4weeks prior to study entry or the day for observation of first end point
6)Patient who recived systemic corticosteroid with a dose of >10mg of predonisolone within 4 weeks prior to the study or during the study and Patients whose corticosteroid dose were changed within 4 weeks prior to the day for observation of first end point
7)Patient who received NSAIDs with an overdosage within 4 weeks prior to the study entry or during the study
(Surgery)
8)Patient who had surgery judged to have an influence on this study by doctor
9)Patient who had the following treatment or procedure: plasma exchange, leukocyte depleted therapy or arthrocentesis against affected joint. except for the arthrocenesis following intraarticular injection of corticosteroid, within 4 weeks prior to the study entry or during the study
(Others)
10)Patient who is in pregnancy, lactating, or with a possibility of the pregnancy and woman who hopes for pregnancy during study or within 1 month after the end of this study, and man who wishes his partner be pregnant during the study or within 3 months after the end of this study
11)Patient who can not go to a hospital for check-up on an appointed day
12)Patient who participated other clinical trial program within 4 months prior to the study entry (including post-marketing clinical study)
13)When principal investigator or sub investigators of this study judge the patients disqualified as a subject of this study
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsukasa Matsubara |
Organization
Matsubara Mayflower Hospital
Division name
Director
Zip code
Address
944-25, Fujitaaza-Higashiyama, Katou-City, Hyougo 673-1462, Japan
TEL
0795-42-8851
mats@mayflower-hp.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsukasa Matsubara |
Organization
Matsubara Mayflower Hospital
Division name
Director
Zip code
Address
944-25, Fujitaaza-Higashiyama, Katou-City, Hyougo 673-1462, Japan
TEL
0795-42-8851
Homepage URL
mats@mayflower-hp.jp
Sponsor or person
Institute
Japan Association of Rheumatologists in Private Practice
Institute
Department
Personal name
Funding Source
Organization
No
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
No
Name of secondary funder(s)
No
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
松原メイフラワー病院（兵庫県）、松野リウマチ整形外科（富山県）、安倍内科医院（東京都）、新横浜山前クリニック（神奈川県）、近藤リウマチ整形外科クリニック（福岡県）、片山整形外科リウマチ科クリニック（北海道）、佐川 昭リウマチクリニック（北海道）、おおにし内科・リウマチ科クリニック（北海道）、吉田整形外科・リウマチ科クリニック（岩手県）、聖路加国際病院 アレルギー膠原病科（東京都）、西間木医院（福島県）、西岡リウマチ・整形外科医院（滋賀県）、防府整形・リウマチクリニック（山口県）、東仙台ﾘｳﾏﾁ科内科クリニック（宮城県）、井上病院（群馬県）、紀尾井町メディカルクリニック（東京都）、戸叶医院（千葉県）、豊流会ツチダクリニック リウマチ科（千葉県）、みやもと医院リウマチ科・整形外科（静岡県）、万波整形外科（京都府）、阿部整形外科リウマチ科ｸﾘﾆｯｸ（兵庫県）、橋本整形外科リウマチクリニック（兵庫県）、東広島記念病院（広島県）、生野ﾘｳﾏﾁ整形外科ｸﾘﾆｯｸ（福岡県）、ピーエスクリニック（福岡県）、織部リウマチ科内科CL（大分県）、富士森内科クリニック（東京都）、よしだ内科クリニック 世田谷リウマチ膠原病センター（東京都）、紫苑会 たかはしクリニック（千葉県）、北海道整形外科記念病院（北海道）、埼玉脳神経外科病院 整形外科リウマチ科（埼玉県）、有限会社 エス・ケー・ラボ（大阪府）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 07 | Month | 01 | 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
| 2010 | Year | 06 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2014 | Year | 10 | Month | 16 | Day |
Date analysis concluded
| 2014 | Year | 11 | Month | 04 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 06 | Month | 23 | Day |
Last modified on
| 2017 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004587
