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
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
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
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
