Clinical trial NCT02335606: Real World Effectiveness of Abatacept in Rheumatoid Arthritis Patients: a Prospective, Single-arm, Open-label, Multi-center Observational Study in Taiwan
Official title: Real World Effectiveness of Abatacept in Rheumatoid Arthritis Patients: a Prospective, Single-arm, Multi-center Observational Study in Taiwan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2015-01-12
Enrollment: 213
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospital : Research based hospital centers, Teaching hospitals affiliated with medical schools, National/Regional medical centers and/or in which thought leaders are employed

Brief summary: Abatacept Registry in Taiwan


Eligibility 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

Primary outcomes:
measure: The retention rate of abatacept therapy over 24 months in RA patients under real world clinical practice in Taiwan.
timeFrame: approximately 24 months
Secondary outcomes:
measure: The retention rate (%) of abatacept therapy at 6, 9, 12, and 18 months in RA patients
timeFrame: at 6, 9, 12, 18, and 24months after study participation
measure: The time to treatment discontinuation in RA patients treated with abatacept
timeFrame: at 6, 9, 12, 18, and 24months after study participation
measure: 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
timeFrame: at 6, 9, 12, 18, and 24months after study participation
measure: 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
timeFrame: at 6, 9, 12, 18, and 24months after study participation
measure: 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
timeFrame: at 6, 9, 12, 18, and 24months after study participation
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: