Rheumatoid Arthritis
Conditions
Brief summary
Abatacept Registry in Taiwan
Interventions
None listed
Sponsors
Bristol-Myers Squibb
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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 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 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 | — |
Countries
Taiwan
Outcome results
None listed