UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015616 |
|---|---|
| Receipt number | R000018150 |
| Scientific Title | Biologic MateR clinical performance test for ADA and TCZ Efficacy prediction |
| Date of disclosure of the study information | 2014/11/10 |
| Last modified on | 2017/05/09 10:26:10 |
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Basic information
Public title
Biologic MateR clinical performance test for ADA and TCZ Efficacy prediction
Acronym
Biologic MateR clinical performance test for ADA and TCZ Efficacy prediction
Scientific Title
Biologic MateR clinical performance test for ADA and TCZ Efficacy prediction
Scientific Title:Acronym
Biologic MateR clinical performance test for ADA and TCZ Efficacy prediction
Region
| Japan |
Condition
Condition
rheumatoid arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Biologic MateR clinical performance test for ADA and TCZ Efficacy prediction
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ADAMTS5mRNA dose at 0wk.
Remission rate and ACR response at 24wk.
Key secondary outcomes
SDAI CDAI and Boolean rates at 24wk.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Adalimumab plus Methotrexate
Interventions/Control_2
Tocilizumab plus 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
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
MTX inadequate response patients with RA diagnosed according to the criteria of 1987ACR and 2010ACR/EULAR
Aged 20 to 75 years at registration
Written informed consent
DAS28-ESR score >=3.2 or DAS28-CRP score >=2.7 at the time of entry
Key exclusion criteria
Be against the guideline of ADA,TCZ and MTX
Patient is otherwise ineligible to participate in this study in the investigator's opinion
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kensei Tsuzaka |
Organization
Iluma Heart Hospital
Division name
Rheumatology
Zip code
Address
358-0026,Koyata,Iruma-shi,Saitama
TEL
04-2934-5050
biologic-mate@npo-acro.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Study Secretariat |
Organization
NPO Advanced Clinical Research Organization(NPO-ACRO)
Division name
ACRO
Zip code
Address
4F Hoei Fuchu Building, 2-10-3 Kotobukicho, Fuchu-shi, Tokyo 183-0056 JAPAN
TEL
042-352-7676
Homepage URL
biologic-mate@npo-acro.jp
Sponsor or person
Institute
Biologic Mate Study Group
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
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
入間ハート病院（埼玉県）、ひろせクリニック（埼玉県）、おがわ内科クリニック（埼玉県）、ツチダクリニック（埼玉県）、せきぐちクリニック（千葉県）、かない内科（千葉県）、順天堂大学医学部附属浦安病院（千葉県）、世田谷リウマチ膠原病センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 11 | Month | 10 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | Month | 04 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 11 | Month | 06 | 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=R000018150
