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

Not Applicable

• Conditions: Rheumatoid Arthritis

• Registration Number: JPRN-UMIN000013757
• Lead Sponsor: Fukuoka Rheumatoid Arthritis Biologics Registry (FRABR)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-04-18
• Study Completion: 2018-01-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.