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Prospective observational study on anti-CCP antibody titer and clinical effect of abatacept (orencia) on patients with rheumatoid arthritis -A pilot study-

Prospective observational study on anti-CCP antibody titer and clinical effect of abatacept (orencia) on patients with rheumatoid arthritis -A pilot study- - FRABR-ABT02

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000013757
Enrollment
50
Registered
2014-04-18
Start date
2014-03-03
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

Fukuoka Rheumatoid Arthritis Biologics Registry (FRABR)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Both genders at more than 20 years old. 2) Patients providing written informed consent. 3) Patients with administration of abatacept (orencia) as a treatment of rheumatoid arthritis. Note1: Give it when an effect is insufficient, even if an appropriate treatment with at least one anti-rheumatic drug is performed in past treatment. Note2: Do not use anti-TNF antibody together with this drug. In addition, avoid combination because the effectiveness and the safety about combination of this drug and other biologics (BIO) are not established.

Exclusion criteria

Exclusion criteria: 1) Patients with history of hypersensitivity to the content of abatacept. 2) Patients with severe infection. 3) Any other patients who are regarded as unsuitable for this study by the investigators

Design outcomes

Primary

MeasureTime frame
Relationship between pre anti-CCP antibody titer and baseline change of SDAI at 24wks, 52wks and 104wks after abatacept administration.

Secondary

MeasureTime frame
1) Relationship between pre anti-CCP antibody titer and baseline change of DAS28-ESR and DAS28-CRP at 24wks, 52wks and 104wks after abatacept administration. 2) Relationship between pre anti-CCP antibody titer and baseline change of QOL improvement effect by using mHAQ at 24wks, 52wks and 104wks after abatacept administration. 3) Baseline change of ant-CCP antibody titer and RF at 12wks, 24wks, 52wks, 76wks and 104months after abatacept administration. 4) Baseline change of MMP-3 at 12wks, 24wks, 52wks, 76wks and 104wks after abatacept administration.

Countries

Japan

Contacts

Public ContactTomomi Tsuru

PS Clinic Department of Rheumatology

tomomi-tsuru@lta-med.com092-283-7777

Outcome results

None listed

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