ICTRP Search Portal

Main

Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	JPRN
Last refreshed on:	17 October 2023
Main ID:	JPRN-UMIN000015616
Date of registration:	10/11/2014
Prospective Registration:	No
Primary sponsor:	Biologic Mate Study Group
Public title:	Biologic MateR clinical performance test for ADA and TCZ Efficacy prediction
Scientific title:	Biologic MateR clinical performance test for ADA and TCZ Efficacy prediction - Biologic MateR clinical performance test for ADA and TCZ Efficacy prediction
Date of first enrolment:	2014/11/04
Target sample size:	300
Recruitment status:	Complete: follow-up complete
URL:	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018150
Study type:	Interventional
Study design:	Parallel Randomized
Phase:	Not selected

Countries of recruitment
Japan

Contacts

Name:	Study Secretariat
Address:	4F Hoei Fuchu Building, 2-10-3 Kotobukicho, Fuchu-shi, Tokyo 183-0056 JAPAN Japan
Telephone:	042-352-7676
Email:	biologic-mate@npo-acro.jp
Affiliation:	NPO Advanced Clinical Research Organization(NPO-ACRO) ACRO

Name:	Kensei Tsuzaka
Address:	358-0026,Koyata,Iruma-shi,Saitama Japan
Telephone:	04-2934-5050
Email:	biologic-mate@npo-acro.jp
Affiliation:	Iluma Heart Hospital Rheumatology

Key inclusion & exclusion criteria

Inclusion criteria:
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

Age minimum: 20years-old
Age maximum: 75years-old
Gender: Male and Female

Health Condition(s) or Problem(s) studied

rheumatoid arthritis

Intervention(s)

Adalimumab plus Methotrexate
Tocilizumab plus Methotrexate

Primary Outcome(s)

ADAMTS5mRNA dose at 0wk. Remission rate and ACR response at 24wk.

Secondary Outcome(s)

SDAI CDAI and Boolean rates at 24wk.

Secondary ID(s)

Source(s) of Monetary Support

none

Secondary Sponsor(s)

Ethics review

Status: YES
Approval date:
Contact:

Results

Results available:
Date Posted:
Date Completed:
URL:

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.