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

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 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


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

Value
https://center6.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