Overview

This trial is active, not recruiting.

Condition rheumatoid arthritis
Treatment abatacept
Sponsor Bristol-Myers Squibb
Start date January 2014
End date February 2017
Trial size 100000 participants
Trial identifier NCT02169544, IM101-488

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Arm
Abatacept
abatacept

Primary Outcomes

Measure
Risk of Lung Cancer
time frame: 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
time frame: 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
time frame: 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
time frame: 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
time frame: 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
time frame: 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
time frame: 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
time frame: 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
time frame: 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
time frame: 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
time frame: 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
time frame: 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)

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Post-marketing Study Assessing the Long-Term Safety of Abatacept
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.