UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037418 |
|---|---|
| Receipt number | 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 | 2022/01/23 13:47:41 |
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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
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
tof.abtstudy@gmail.com
Sponsor or person
Institute
The Hirose Clinic of Rheumatology
TOF-ABT study Office
Institute
Department
Personal name
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
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
Partially published
Result
URL related to results and publications
DOI:10.1186/s13075-021-02612-w
Number of participants that the trial has enrolled
400
Results
There was no significant difference in the proportion of patients achieving DAS28-ESR remission between the TOF and ABT groups at week24, while change in DAS28-ESR from baseline to week4 was significantly greater in TOF than in ABT. Analysis of EULAR response at week 24 showed that the proportion of patients who achieved a good EULAR response in TOF group was not affected by number of SE copies, whereas in ABT group it was increased significantly with increasing number of SE copies.
Results date posted
| 2021 | Year | 07 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 08 | Month | 31 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
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
| 2022 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042658
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| Registered date | File name |
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