UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Tsukasa Matsubara
Organization	Matsubara Mayflower Hospital
Division name	Director
Address	944-25, Fujitaaza-Higashiyama, Katou-City, Hyougo 673-1462, Japan
TEL	0795-42-8851
Email	mats@mayflower-hp.jp

Public contact
Name of contact person	Tsukasa Matsubara
Organization	Matsubara Mayflower Hospital
Division name	Director
Address	944-25, Fujitaaza-Higashiyama, Katou-City, Hyougo 673-1462, Japan
TEL	0795-42-8851
Homepage URL
Email	mats@mayflower-hp.jp

Sponsor
Institute	Japan Association of Rheumatologists in Private Practice
Institute
Department

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

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

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 06 Month 09 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004587