UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	"Effect examination of infliximab to the effect insufficient example and the example of effect decrease of the 1st TNF inhibitor in rheumatoid arthritis "
Title of the study (Brief title)	Effect examination of infliximab to an anti-TNF invalid example
Region	Japan

Condition
Condition	Rheumatoid Arthritis
Classification by specialty	Clinical immunology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Other TNF inhibitor are prescribed for the patient as the 1st selection, IFX is prescribed for the patient to effect insufficiency or the case which carried out effect decrease, and a follow-up survey of the validity is conducted.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	the remission rate of 1-2years after(DAS28(4)-CRP<2.3 or DAS28(4)-ESR<2.6 or SDAI<3.3 or CDAI<2.8)
Key secondary outcomes	the low disease activity maintenance rate of 1-2 years after (DAS28(4)-ESR<3.2 or SDAI<11 or CDAI<10 the low disease activity maintenance rate of 1-2 years after (DAS28(4)-ESR<3.2 or SDAI<11 or CDAI<10

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	infliximab 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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	The patient whom is prescribing TNF inhibitors other than infliximab for the patient, and the disease activity (DAS28(4)-ESR >3.2, SDAI>11, or CDAI>10) more than the degree of middle class is maintaining over 12 or more weeks
Key exclusion criteria	"1) The patient who is having infliximab medical treatment already experienced 2) The patient who cannot prescribe a methotrexate tablet for the patient 3) The patient who is experienced in TNF inhibitors as for more than 2 agent 4) In addition, the patient who judged that a research doctor was unsuitable "
Target sample size	40

Research contact person
Name of lead principal investigator	Koichi Amano
Organization	Saitama Medical Center. Saitama Medical University
Division name	Division of Rheumatology and Clinical Immunology
Address	1981 Kamoda, Kawagoe-shi, SAITAMA
TEL	0492283859
Email	amanokoi@saitama-med.ac.jp

Public contact
Name of contact person	Koichi Amano
Organization	Saitama Medical Center. Saitama Medical University
Division name	Department of Rheumatology & Clinical Immunology
Address	1981 Kamoda, Kawagoe-shi, SAITAMA
TEL	0492283859
Homepage URL
Email	amanokoi@saitama-med.ac.jp

Sponsor
Institute	Saitama Medical Center. Saitama Medical University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Saitama Medical Center, Saitama Medical Universitity
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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

Other administrative information
Date of disclosure of the study information	2012 Year 04 Month 19 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 04 Month 15 Day
Anticipated trial start date	2012 Year 05 Month 01 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry	2018 Year 04 Month 30 Day
Date trial data considered complete	2018 Year 05 Month 31 Day
Date analysis concluded	2018 Year 07 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 04 Month 19 Day
Last modified on	2016 Year 04 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009176