UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000007404
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Institute KONAMON Study Group
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

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
URL(English) https://upload.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


Contact us.