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

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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: Abatacept

• Study Type: Observational
• Enrollment (Actual): 100000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients will be selected from 4 US claims databases

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
RA patients who are prescribed Abatacept; Abatacept	Drug: Abatacept
Patients who are prescribed other RA treatments

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)
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)
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2014
• Primary Completion (Actual): February 28, 2017
• Study Completion (Actual): February 28, 2017

Study Registration Dates

• First Submitted: May 14, 2014
• First Submitted That Met QC Criteria: June 19, 2014
• First Posted (Estimate): June 23, 2014

Study Record Updates

• Last Update Posted (Actual): April 25, 2017
• Last Update Submitted That Met QC Criteria: April 24, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Immune Checkpoint Inhibitors; Abatacept
• Other Study ID Numbers: IM101-488