UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009088 |
|---|---|
| Receipt number | R000010662 |
| Scientific Title | Bio Logic MateTM clinical performance test for IFX Efficacy prediction |
| Date of disclosure of the study information | 2012/10/12 |
| Last modified on | 2017/05/09 11:25:53 |
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Basic information
Public title
Bio Logic MateTM clinical performance test for IFX Efficacy prediction
Acronym
Bio Logic MateTM clinical performance test for IFX Efficacy prediction
Scientific Title
Bio Logic MateTM clinical performance test for IFX Efficacy prediction
Scientific Title:Acronym
Bio Logic MateTM clinical performance test for IFX Efficacy prediction
Region
| Japan |
Condition
Condition
rheumatoid arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Bio Logic MateTM clinical performance test for IFX Efficacy prediction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ADAMTS5mRNA dose at 0W estimation at 14W(DAS28).
Key secondary outcomes
CDAI,SDAI,Boolean Definition estimation at 14W(CDAI,SDAI,Boolean Definition)estimation at 52W(CDAI,SDAI,Boolean Definition).
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
IFX plus methotrexate
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients with RA diagnosed according to the criteria of 1987 ACR and 2010ACR/EULAR.
2. Aged 20 to 75 years at registration.
3. Written informed consent.
4. DAS28-ESR score>=3.2 at the time of entry.
Key exclusion criteria
1. Be against the guideline of IFX and MTX.
2. Paitient is otherwise ineligible to participate in this study in the investigator's opinion.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kensei Tsuzaka |
Organization
Tokyo Dental College Ichikawa General Hospital
Division name
Department of Internal Medicine
Zip code
Address
5-11-13 Sugano, Ichikawa, Chiba, Japan
TEL
047-322-0151
biologic-mate@npo-acro.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | ACRO |
Organization
NPO Advanced Clinical Research Organization
Division name
ACRO
Zip code
Address
4F Hoei Fuchu Building, 2-10-3 Kotobukicyo, Fucyu-shi, Toyo, Japan
TEL
042-352-7676
Homepage URL
biologic-mate@npo-acro.jp
Sponsor or person
Institute
Bio Logic Mate Study Group
Institute
Department
Personal name
Funding Source
Organization
Bio Logic Mate Study Group
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
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
埼玉医科大学総合医療センター（埼玉県）、松戸市立病院（千葉県）、済世会習志野病院（千葉県）、順天堂浦安病院（千葉県）、千葉大学（千葉県）、国府台病院（千葉県）、下志津病院（千葉県）、旭中央病院（千葉県）、鎌ヶ谷総合病院（千葉県）、千葉西総合病院（千葉県）、埼玉医科大学病院（埼玉県）、千葉東病院（千葉県）、ツチダクリニック（千葉県）、入間ハート病院（埼玉県）、せきぐちクリニック（千葉県）、たかはしクリニック（千葉県）、東京歯科大学市川総合病院（千葉県）、東邦大学医療センター佐倉病院（千葉県）、みつかリウマチクリニック（千葉県）、かない内科（千葉県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 10 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2012 | Year | 09 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 10 | 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 | 10 | Month | 11 | Day |
Last modified on
| 2017 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010662
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
