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

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT02335606
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

Abatacept Registry in Taiwan

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08-06
• Study First Submitted: 2015-01-07
• Study First Submitted QC: 2015-01-07
• Study First Posted: 2015-01-12
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-06
• Last Update Posted: 2022-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 213

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The retention rate of abatacept therapy over 24 months in RA patients under real world clinical practice in Taiwan.	approximately 24 months	Treatment retention rate is defined as the proportion of subjects who use abatacept for 24 months

Secondary Outcome Measures

Name	Time	Method
The retention rate (%) of abatacept therapy at 6, 9, 12, and 18 months in RA patients	at 6, 9, 12, 18, and 24months after study participation
The proportion of patients achieving DAS28 ≤ 2.6, 2.6 < DAS28 ≤ 3.2, 3.2 < DAS28 ≤ 5.1, DAS> 5.1 at 6, 9, 12, 18, and 24months	at 6, 9, 12, 18, and 24months after study participation
The demographic, clinical presentation, and disease management a composite measure of RA patients who are using abatacept (either formulation) or are abatacept naïve at Month 6, 9, 12, 18, and 24	at 6, 9, 12, 18, and 24months after study participation
The major reason for treatment discontinuation (eg, lack of efficacy, severe adverse drug reactions, switch from abatacept to another RA medication, financial issues, etc) at 6, 9, 12, 18, and 24 months	at 6, 9, 12, 18, and 24months after study participation
The time to treatment discontinuation in RA patients treated with abatacept	at 6, 9, 12, 18, and 24months after study participation	Treatment discontinuation is defined as patients who cease treatment for \> 8 weeks

Trial Locations

Locations (1)

Local Institution; 🇨🇳 Taipei, Taiwan