UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000015616
Receipt No. 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

* 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 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
Email 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
Email biologic-mate@npo-acro.jp

Sponsor
Institute Biologic Mate Study Group
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018150

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.