Post-marketing Study Assessing the Long-Term Safety of Abatacept

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Abatacept

• Registration Number: NCT02169544
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-31
• Study First Submitted: 2014-05-14
• Study First Submitted QC: 2014-06-19
• Study First Posted: 2014-06-23
• Primary Completion: 2017-02-28
• Study Completion: 2017-02-28
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-24
• Last Update Posted: 2017-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100000

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
RA patients who are prescribed Abatacept	Abatacept	Abatacept

Primary Outcome Measures

Name	Time	Method
Risk of Lung Cancer	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)	The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug
Risk of lymphoma	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)	The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug
Risk of breast cancer	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)	The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug
Risk of non-melanoma skin cancer	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)	The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug
Risk of all malignancies	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)	The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug
Risk of hospitalized infections	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)	The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug
Risk of pneumonia	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)	The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug
Risk of opportunistic infections	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)	The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug
Risk of tuberculosis	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)	The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug

Secondary Outcome Measures

Name	Time	Method
Incidence of lupus	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)	The index date is defined as the date that the patient initiates Abatacept
Incidence of multiple sclerosis	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)	The index date is defined as the date that the patient initiates Abatacept
Incidence of psoriasis	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)	The index date is defined as the date that the patient initiates Abatacept