UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037837
Receipt number R000043138
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)
Date of disclosure of the study information 2019/09/01
Last modified on 2021/08/30 22:01:42

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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 or person

Institute

Matsubara Mayflower Hospital

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043138


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name