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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000037418
Receipt No. R000042658
Scientific Title Comparison of the efficacies of tofacitinib and abatacept in patients with rheumatoid arthritis by propensity score matching and their clinical significance
Date of disclosure of the study information 2019/07/21
Last modified on 2019/07/21

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Basic information
Public title Comparison of the efficacies of tofacitinib and abatacept in patients with rheumatoid arthritis by propensity score matching and their clinical significance
Acronym Comparison of efficacies of tofacitinib and abatacept in patients with rheumatoid arthritis (TOF-ABT study)
Scientific Title Comparison of the efficacies of tofacitinib and abatacept in patients with rheumatoid arthritis by propensity score matching and their clinical significance
Scientific Title:Acronym Comparison of efficacies of tofacitinib and abatacept in patients with rheumatoid arthritis (TOF-ABT study)
Region
Japan

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

Objectives
Narrative objectives1 The efficacies of tofacitinib and abatacept in rheumatoid arthritis (RA) in clinical practice is compared in multicenter trials. Comparisons are made using propensity score matching to eliminate the effects of selection bias and confounding factors in observational studies. In addition, we analyze HLA-DRB1 alleles of target patients and investigate the influence of shared epitopes on the therapeutic effect of each drug.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Comparison of DAS28-ESR remission rates between tofacitinib (TOF) and abatacept (ABT) at 6 months after initiation of treatment
Key secondary outcomes 1. Comparison of RA disease activity (changes in DAS28-ESR, SDAI and CDAI scores and EULAR response criteria) between the TOF nd ABT groups at 6 months of treatment initiation.
2. Comparison of RA disease activity (changes in DAS28-ESR, SADI and CDAI scores and EULAR response criteria) and changes in total Sharp score and HAQ-DI between the TOF and ABT groups at 12 months after the initiation of treatment.
3. Analysis of retention rates in the TOF and ABT groups up to 12 months after administration.
4. Analysis of factors contributing to DAS28-ESR remission at 6 months after treatment initiation in the TOF and ABT groups.
5. Analysis of the influence of shared epitopes on DAS28-ESR remission in the TOF and ABT groups at 6 months after treatment initiation.

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Patients who were diagnosed with RA according to the 2010 American college of Rheumatology / European League against Rheumatism classification criteria.
2. All patients who started treatment with TOF or ABT between December 2014 and January 2021 at 12 hospitals and clinics of rheumatology were registered.
3. HLA-DRB1 allele analysis can not be performed on subjects who do not have consent for genetic analysis studies.
Key exclusion criteria 1.Patients who meet contraindications for administration of TOF or ABT
2. Pregnant women, nursing women or patients with hope of pregnancy
3. Inability to give informed consent.
Target sample size 400

Research contact person
Name of lead principal investigator
1st name Wataru
Middle name
Last name HIROSE
Organization The Hirose Clinic of Rheumatology
Division name Rheumatology Division
Zip code 359-1111
Address 2-14-7 Midori-chou, Tokorozawa, Saitama
TEL 04-2920-2111
Email tof.abtstudy@gmail.com

Public contact
Name of contact person
1st name Shota
Middle name
Last name TANABE
Organization The Hirose Clinic of Rheumatology
Division name TOF-ABT Research Office
Zip code 359-1111
Address 2-14-7 Midori-chou, Tokorozawa, Saitama
TEL 04-2920-2111
Homepage URL
Email tof.abtstudy@gmail.com

Sponsor
Institute The Hirose Clinic of Rheumatology
TOF-ABT study Office
Institute
Department

Funding Source
Organization Self funding
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 The ehics review boad of the Toho University School of Medicine
Address 5-21-16 Ohmori-nishi, Ota-ku 143-8540 Tokyo
Tel 03-5763-6504
Email med.rinri@ext.toho-u.ac.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 医療法人社団光城会ひろせクリニック、防衛医科大学校アレルギー膠原病科(埼玉県)、埼玉医科大学総合医療センターリウマチ膠原病内科(埼玉県)、安藤医院(埼玉県)、青木内科クリニック(埼玉県)、長澤クリニック(埼玉県)、かねこ内科医リウマチ科クリニック(埼玉県)、すずひろクリニック(埼玉県)、新座志木中央総合病院(埼玉県)、成島医院(茨城県)、十条武田リハビリテーション病院(京都府)、善仁会 市民の森病院(宮崎県)

Other administrative information
Date of disclosure of the study information
2019 Year 07 Month 21 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 01 Month 17 Day
Date of IRB
2019 Year 03 Month 27 Day
Anticipated trial start date
2019 Year 03 Month 27 Day
Last follow-up date
2021 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Retrospective observational study, but genetic analysis is prospective

Management information
Registered date
2019 Year 07 Month 18 Day
Last modified on
2019 Year 07 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042658

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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