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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02169544
• Other study ID #: IM101-488
• Status: Completed
• Phase: N/A
• First received: May 14, 2014
• Last updated: April 24, 2017
• Start date: January 31, 2014
• Est. completion date: February 28, 2017

Study information

• Verified date: April 2017
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100000
• Est. completion date: February 28, 2017
• Est. primary completion date: February 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Abatacept

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Risk of Lung Cancer	The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug	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)
Primary	Risk of lymphoma	The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug	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)
Primary	Risk of breast cancer	The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug	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)
Primary	Risk of non-melanoma skin cancer	The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug	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)
Primary	Risk of all malignancies	The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug	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)
Primary	Risk of hospitalized infections	The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug	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)
Primary	Risk of pneumonia	The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug	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)
Primary	Risk of opportunistic infections	The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug	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)
Primary	Risk of tuberculosis	The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug	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	Incidence of lupus	The index date is defined as the date that the patient initiates Abatacept	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)
Secondary	Incidence of multiple sclerosis	The index date is defined as the date that the patient initiates Abatacept	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)
Secondary	Incidence of psoriasis	The index date is defined as the date that the patient initiates Abatacept	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)

External Links

•   BMS Clinical Trials Disclosure
•   FDA Safety Alerts and Recalls