Clinical trial NCT02169544: Post-marketing Study Assessing the Long-Term Safety of Abatacept
Official title: Post-marketing Study Assessing the Long-Term Safety of Abatacept
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2014-06-23
Enrollment: 100000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients will be selected from 4 US claims databases

Brief summary: The purpose of this study is to evaluate the risk of infections and malignancies among Rheumatoid Arthritis (RA) patients treated with Abatacept compared to other RA treatments.


Eligibility criteria: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Patient has at least two claims for RA (714.xx) in the 180 days prior to and including the index date (baseline period)
* Patient is aged 18 years or older on the index date
* Patient was enrolled in the database for at least 180 days before the index date
* Patient is newly prescribed Abatacept or another RA treatment and has at least two claims for the treatment

Primary outcomes:
measure: Risk of Lung Cancer
timeFrame: Cancer: From 180 days after the index date until the first of the following: event of interest, death, or end of study (approximately 2 years)
measure: Risk of lymphoma
timeFrame: Cancer: From 180 days after the index date until the first of the following: event of interest, death, or end of study (approximately 2 years)
measure: Risk of breast cancer
timeFrame: Cancer: From 180 days after the index date until the first of the following: event of interest, death, or end of study (approximately 2 years)
measure: Risk of non-melanoma skin cancer
timeFrame: Cancer: From 180 days after the index date until the first of the following: event of interest, death, or end of study (approximately 2 years)
measure: Risk of all malignancies
timeFrame: Cancer: From 180 days after the index date until the first of the following: event of interest, death, or end of study (approximately 2 years)
measure: Risk of hospitalized infections
timeFrame: Infection: From the index date until the first of the following: end of treatment +90 days, event of interest, death or end of study (approximately 1 year)
measure: Risk of pneumonia
timeFrame: Infection: From the index date until the first of the following: end of treatment +90 days, event of interest, death or end of study (approximately 1 year)
measure: Risk of opportunistic infections
timeFrame: Infection: From the index date until the first of the following: end of treatment +90 days, event of interest, death or end of study (approximately 1 year)
measure: Risk of tuberculosis
timeFrame: Infection: From the index date until the first of the following: end of treatment +90 days, event of interest, death or end of study (approximately 1 year)
Secondary outcomes:
measure: Incidence of lupus
timeFrame: Outcomes will be assessed from 180 days after the index date until the first of the following: event of interest, death, or end of study (approximately 2 years)
measure: Incidence of multiple sclerosis
timeFrame: Outcomes will be assessed from 180 days after the index date until the first of the following: event of interest, death, or end of study (approximately 2 years)
measure: Incidence of psoriasis
timeFrame: Outcomes will be assessed from 180 days after the index date until the first of the following: event of interest, death, or end of study (approximately 2 years)
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: