UMIN-CTR Clinical Trial

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

Rheumatoid Arthritis

Classification by specialty

Clinical immunology

Orthopedics

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

mats@mayflower-hp.jp

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

Email

mats@mayflower-hp.jp

Institute

Japan Association of Rheumatologists in Private Practice

Institute

Department

Personal name

Organization

No

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

No

Name of secondary funder(s)

No

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2010

Year

07

Month

01

Day

URL releasing protocol

Publication of results

Published

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

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 related 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