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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02335606
• Other study ID #: IM101-440
• Status: Completed
• Start date: August 6, 2014
• Est. completion date: December 31, 2018

Study information

• Verified date: January 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Abatacept Registry in Taiwan

Recruitment information / eligibility

• Status: Completed
• Enrollment: 213
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
Taiwan	Local Institution	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The retention rate of abatacept therapy over 24 months in RA patients under real world clinical practice in Taiwan.	Treatment retention rate is defined as the proportion of subjects who use abatacept for 24 months	approximately 24 months
Secondary	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
Secondary	The time to treatment discontinuation in RA patients treated with abatacept	Treatment discontinuation is defined as patients who cease treatment for > 8 weeks	at 6, 9, 12, 18, and 24months after study participation
Secondary	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
Secondary	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
Secondary	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

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls