Real World Effectiveness of Abatacept in Rheumatoid Arthritis Patients: a Prospective, Single-arm, Open-label, Multi-center Observational Study in Taiwan

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: Rheumatoid Arthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT02335606

IM101-440

Details and patient eligibility

About

Abatacept Registry in Taiwan

Enrollment: 213 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• ≥ 20 years of age
• Who give informed consent
• Confirmed diagnosis of RA (as defined by American College of Rheumatology revised 1987 criteria) and has ≥ 4 of the criteria listed below for ≥6 weeks before study enrollment
• Who self-pay or who are reimbursed by BNHI for abatacept treatment
• With latent TB or who are receiving anti-TB treatment (INH 300 mg, QD) 1 month prior to using abatacept and continuously up to a total of 9 months Willing to follow Taiwan Risk Management Plan guidelines as required by Taiwan health authorities
• Are being treated with abatacept or are abatacept treatment naïve and are initiating abatacept therapy

Exclusion Criteria:

• Pregnant or breast feeding
• With active TB
• HBsAg (+)and/or Anti-HCV(+) and/or HBV DNA(+)
• Have cancer (patients who were treated and have no sign of cancer for > 10 years can be included)
• Are allergic to abatacept
• Enrolled in other RA clinical studies

Trial design

213 participants in 1 patient group

Patients treating with Abatacept

Description:

Patients who are abatacept naive and are initiating abatacept treatment (either IV or SC) including those that are switching from another bDMARD, as well as, patients currently being treated with IV or SC abatacept some of which may have switched from IV abatacept to SC abatacept