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Study of factors predicting the efficacy of abatacept in patients with rheumatoid arthritis

Effect of combined abnormalities in both genome sequences and immune-phenotypes in the efficacy of abatacept on patients with rheumatoid arthritis - Effect of genome and immune-phenotypes in the efficacy of abatacept

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000042329
Enrollment
150
Registered
2020-11-02
Start date
2019-06-01
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

Sponsors

University of Occupational and Environmental Health, Japan
Lead Sponsor
Department of Statistical Genetics, Osaka University Graduate School of Medicine, Osaka, Japan
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) RA patients satisfying the ACR/EULAR RA Classification Criteria 2010 2) Patients with RA poorly responding to treatment with one or more csDMARDs and having received no biopharmaceutical before 3) Patients aged 20 and over at the time of issuing consent to this study 4) Patients having begun to receive subcutaneous injection of abatacept on the basis of the attending physician's decision

Exclusion criteria

Exclusion criteria: 1) Patients with a history of allergy to any component of abatacept 2) Patients with complication by malignant tumor 3) Patients with active infection or hepatitis B and HB carrier 4) Pregnant women, lactating women or women desiring pregnancy, child delivery or breast-feeding 5) Patients judged as inappropriate for this study by Principal Investigator or Sub-investigator

Design outcomes

Primary

MeasureTime frame
Achievement rate of DAS28-CRP> 1.2 improvement 12 months after abatacept administration

Secondary

MeasureTime frame
1) Identification of subgroups the patients according to their abnormality patterns in both SNP existence and baseline immune-phenotype profiles 2) Identification of patient subgroups for which abatacept is more efficacious

Countries

Japan

Contacts

Public ContactShingo Nakayamada

University of Occupational and Environmental Health, Japan First Department of Internal Medicine

s-nakaya@med.uoeh-u.ac.jp093-603-1611

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026