UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007404
Receipt number R000008685
Scientific Title Open-label, multicenter, randomized controlled trials, for comparing remission induction rate of a dose-escalation therapy of methotrexate and an additional combination therapy with bucillamine for naive patients to over 8 mg/weekly of methotrexate.
Date of disclosure of the study information 2012/03/01
Last modified on 2013/03/05 16:32:06

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Basic information

Public title

Open-label, multicenter, randomized controlled trials, for comparing remission induction rate of a dose-escalation therapy of methotrexate and an additional combination therapy with bucillamine for naive patients to over 8 mg/weekly of methotrexate.

Acronym

Comparison between concomitant therapy of non-biologic anti-rheumatic drugs and therapy with MTX dose escalation aiming for remission on RA patient (CONAMON Study)

Scientific Title

Open-label, multicenter, randomized controlled trials, for comparing remission induction rate of a dose-escalation therapy of methotrexate and an additional combination therapy with bucillamine for naive patients to over 8 mg/weekly of methotrexate.

Scientific Title:Acronym

Comparison between concomitant therapy of non-biologic anti-rheumatic drugs and therapy with MTX dose escalation aiming for remission on RA patient (CONAMON Study)

Region

Japan


Condition

Condition

Rheumatoid arthritis

Classification by specialty

Clinical immunology Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Comparing for efficacy of the treatment strategies based on dose escalation of methotrexate with the treatment strategy based on additional combination therapy of bucillamine, in order to achieve a control of disease activity aiming for remission induction to the patient who was naive to over 8mg/weekly of MTX.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

average DAS28 score on 6 months

Key secondary outcomes

Progression of total Sharp Score from base line on 12 months
functional remission rate on 6 months and 12months (mHAQ<0.5)
remission rate on 12 months
mean of MMP-3 on 6 months and 12 months
decrease in MMP-3 from base line on 6months and 12 months


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Dose escalation of methotrexate

Interventions/Control_2

Concomitant therapy of methotrexate and bucillamine

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 with RA who satisfied classification criteria prepared by ACR and EULAR in 2010
Patients who have never recieved over 8mg/weekly of methotrexate
Patient who have no experience with treatment of bucillamine and biologics
Patients who is not clinical remission state by DAS28
Patients whom physician has determined require of dose-escalation
Patient who can be submitted consent in writing and written signature on consent document

Key exclusion criteria

APatients 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

90


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name KOICHIRO TAKAHI

Organization

TONEYAMA National Hospital

Division name

Department of orthopedic surgery

Zip code


Address

5-1-1, Toneyama, Toyonaka City, Osaka 560-8552, Japan

TEL

06-6853-2001

Email



Public contact

Name of contact person

1st name
Middle name
Last name KOICHIRO TAKAHI

Organization

TONEYAMA National Hospital

Division name

Department of orthopedic surgery

Zip code


Address

5-1-1, Toneyama, Toyonaka City, Osaka 560-8552, Japan

TEL

06-6853-2001

Homepage URL


Email

ktakahi@toneyama.go.jp


Sponsor or person

Institute

KONAMON Study Group

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


Email



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

独立行政法人 国立病院機構 刀根山病院(大阪府) Tnoneyama National Hospital
独立行政法人 国立病院機構 大阪南医療センター(大阪府) National Hospital Organization Osaka MInami Medical Center
星ヶ丘厚生年金病院(大阪府) Hoshigaoka Kouseinenkin Hospital
独立行政法人 労働者健康福祉機構 大阪労災病院(大阪府) Osaka Rosai Hospital


Other administrative information

Date of disclosure of the study information

2012 Year 03 Month 01 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

2011 Year 09 Month 27 Day

Date of IRB


Anticipated trial start date

2013 Year 01 Month 01 Day

Last follow-up date

2014 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 02 Month 29 Day

Last modified on

2013 Year 03 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008685


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name