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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02335606 |
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Date of registration:
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07/01/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Real World Effectiveness of Abatacept in Rheumatoid Arthritis Patients: a Prospective, Single-arm, Open-label, Multi-center Observational Study in Taiwan
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Scientific title:
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Real World Effectiveness of Abatacept in Rheumatoid Arthritis Patients: a Prospective, Single-arm, Multi-center Observational Study in Taiwan |
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Date of first enrolment:
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October 6, 2013 |
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Target sample size:
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318 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02335606 |
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Study type:
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Observational [Patient Registry] |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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Taiwan
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Contacts
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Name:
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Bristol-Myers Squibb |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bristol-Myers Squibb |
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Key inclusion & exclusion criteria
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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
Age minimum:
20 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
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Primary Outcome(s)
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The retention rate of abatacept therapy over 24 months in RA patients under real world clinical practice in Taiwan.
[Time Frame: approximately 24 months]
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Secondary Outcome(s)
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The time to treatment discontinuation in RA patients treated with abatacept
[Time Frame: at 6, 9, 12, 18, and 24months after study participation]
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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
[Time Frame: at 6, 9, 12, 18, and 24months after study participation]
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The retention rate (%) of abatacept therapy at 6, 9, 12, and 18 months in RA patients
[Time Frame: at 6, 9, 12, 18, and 24months after study participation]
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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
[Time Frame: at 6, 9, 12, 18, and 24months after study participation]
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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
[Time Frame: at 6, 9, 12, 18, and 24months after study participation]
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Secondary ID(s)
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IM101-440
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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