UMIN-CTR Clinical Trial

Basic information
Public title	Clinical genome study on the individual differences of infliximab-BS(CTH) subjected to Japanese and Korean rheumatoid arthritis patients at large number of facilities (1) Clinical genome study on the drug responsiveness of Japanese rheumatoid arthritis patients towards infliximab-BS(CTH)
Acronym	Clinical genome study on the drug responsiveness of Japanese rheumatoid arthritis patients towards infliximab-BS(CTH)
Scientific Title	Clinical genome study on the individual differences of infliximab-BS(CTH)subjected to Japanese and Korean rheumatoid arthritis patients at large number of facilities (1)Clinical genome study on the drug responsiveness of Japanese rheumatoid arthritis patients towards infliximab-BS(CTH)
Scientific Title:Acronym	Clinical genome study on the drug responsiveness of Japanese rheumatoid arthritis patients towards infliximab-BS(CTH)
Region	Japan

Condition
Condition	Rheumatoid arthritis
Classification by specialty	Clinical immunology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	The goals of the 1st stage of this research, "Clinical genome study on the drug responsiveness of Japanese rheumatoid arthritis patients towards infliximab-BS [CTH]," set under this study plan include review of the genomic drug responsiveness of the Japanese RA patients who switched from Infliximab to other biological drugs other than Infliximab or BIO-naive case, and patients who switched from the original drug, Infliximab, to generic medical product, Infliximab-BS [CTH].
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	SNPs that stipulate drug responsiveness to Infliximab-BS [CTH]
Key secondary outcomes	1.Comparison of SNPs that stipulate drug responsiveness to Infliximab-BS(CTH) and original medical drug, infliximab (effectiveness and safety) 2.Infliximab trough value and quantity of anti-drug antibody prior to and after the administration of Infliximab-BS(CTH)

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Among the patients who are undergoing treatments as outpatients or hospitalized at the research institutes, 100 patients diagnosed with rheumatoid arthritis and scheduled to be administered with or already being administered with Infliximab-BS(CTH), who were "requested for cooperation with the research on rheumatoid arthritis" by the personnel in charge of the execution of the research or medical doctor at the cooperative institution for the execution of the research and provided documentary consent by using "Letter of consent for cooperation with research on rheumatoid arthritis"(Attachments(1) and (2)) are selected as the subjects of the research.
Key exclusion criteria	The patients administered with Infliximab-BS sold by other company is excluded.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Tsukasa Middle name Last name Matsubara
Organization	Matsubara Mayflower Hospital
Division name	Director
Zip code	673-1462
Address	944-25, Fujita, Kato, Hyogo, 673-462
TEL	0795-42-8851
Email	mats@mayflower-hp.jp

Public contact
Name of contact person	1st name Keiko Middle name Last name Funahashi
Organization	research institute of Joint Disease
Division name	Vice president
Zip code	650-0044
Address	1-7-4, Higashikawasaki-cho, Chuou-ku, Kobe City, Hyogo
TEL	078-515-6145
Homepage URL
Email	kansetsusaisei123@cup.ocn.ne.jp

Sponsor
Institute	Matsubara Mayflower Hospital
Institute
Department

Funding Source
Organization	Celltrion Healthcare Co., Ltd
Organization
Division
Category of Funding Organization	Outside Japan
Nationality of Funding Organization	Korea

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

IRB Contact (For public release)
Organization	Matsubara Mayflower Hospital Ehics Committee
Address	944-25, Fujita, Kato, Hyogo, 673-1462
Tel	0795-42-8851
Email	tiken@mayflower-hp.jp

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	佐川昭リウマチクリニック（北海道） 生野リウマチ整形外科クリニック（福岡県） 泉原リウマチ・内科クリニック（鹿児島県） 片山整形外科リウマチ科クリニック（北海道） ツチダクリニック（千葉県） ピーエスクリニック（福岡県） 織部リウマチ科内科クリニック（大分県） 東広島記念病院リウマチ・膠原病センター（広島県） あずまリウマチ・内科クリニック（埼玉県） 松原クリニック（兵庫県） 松原メイフラワー病院（兵庫県） 武富整形外科 川崎リウマチ・内科クリニック

Other administrative information
Date of disclosure of the study information	2019 Year 09 Month 01 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	Enrolling by invitation
Date of protocol fixation	2019 Year 06 Month 04 Day
Date of IRB	2019 Year 07 Month 10 Day
Anticipated trial start date	2019 Year 09 Month 01 Day
Last follow-up date	2022 Year 12 Month 31 Day
Date of closure to data entry	2023 Year 04 Month 30 Day
Date trial data considered complete	2023 Year 06 Month 30 Day
Date analysis concluded	2023 Year 12 Month 31 Day

Other

Other related information

12.4 Observation period Shorter of 1 year after commencement of administration and time of cessation of participation on the study will be the period of observation. 12.5 Clinical data 1) Evaluation of patient for whom the original medical drug, Infliximab, was not administered Effectiveness and safety are evaluated with the drug responsiveness as the relevant data.Regarding the effectiveness, evaluate DAS28 at the time of commencement and at 30th week of administration of Infliximab-BS [CTH]. If the activity of DAS28 disease at the 30th week is less than 3.2, it is determined as effective group and if it is higher than 3.2, as an ineffective group. Regarding the safety, evaluate the presence of side effects throughout the entire period of evaluation. 2) Evaluation of patients who switched from the original medical drug, Infliximab, to infliximab-BS [CTH] Regarding switching to infliximab-BS [CTH] in clinical setting, valid and citable cases of original medical drug will become the subjects. Therefore, groups with DAS28 disease activity of less than 3.2 at about half a year (32 weeks) after the switch will be determined as effective groups. Drug concentration and anti-drug antibody will be measured for the purpose of considerations on the causal relationship in the event of occurrence of attenuation of effectiveness after the switch. Evaluate all safety issues that occurred after the switch and compare and review the safety as the time of the use of original medical drug. Although the period of the use of the original medical drug, Infliximab, is not set, administration dose of the original medical drug, Infliximab, is not altered at the time of switch. However, it is possible to alter the administration dose due to reasons such as attenuation of effectiveness after the administration.

Management information
Registered date	2019 Year 08 Month 28 Day
Last modified on	2021 Year 08 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043138