Comparison of the efficacies of tofacitinib and abatacept in patients with rheumatoid arthritis by propensity score matching and their clinical significance

Comparison of the efficacies of tofacitinib and abatacept in patients with rheumatoid arthritis by propensity score matching and their clinical significance - Comparison of efficacies of tofacitinib and abatacept in patients with rheumatoid arthritis (TOF-ABT study)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000037418

Enrollment

400

Registered

2019-07-21

Start date

2019-03-27

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid arthritis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Comparison of DAS28-ESR remission rates between tofacitinib (TOF) and abatacept (ABT) at 6 months after initiation of treatment	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Japan

Contacts

Public ContactShota TANABE

The Hirose Clinic of Rheumatology TOF-ABT Research Office

tof.abtstudy@gmail.com04-2920-2111

Outcome results