Overview

This trial is active, not recruiting.

Condition rheumatoid arthritis
Sponsor Bristol-Myers Squibb
Collaborator National Data Bank for Rheumatic Diseases (NDB)
Start date March 2005
End date March 2017
Trial size 20000 participants
Trial identifier NCT01088360, IM101-045B

Summary

The purpose of this study is to compare the incidence rates of targeted infections, malignancies and mortality among patients with rheumatoid arthritis who are treated with abatacept and those who are treated with other anti-rheumatic medications.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm

Primary Outcomes

Measure
Key safety outcomes (targeted infections, malignancies, mortality)
time frame: Every 6 months throughout the study

Secondary Outcomes

Measure
Patient-reported infusion reactions
time frame: Every 6 months throughout the study
Multiple sclerosis, lupus, and psoriasis
time frame: Every 6 months throughout the study
Adverse events in pregnant women who receive abatacept
time frame: Every 6 months throughout the study
Adverse events in subjects on abatacept who receive concomitant biologics
time frame: Every 6 months throughout the study

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Signed informed consent - Diagnosis of rheumatoid arthritis - > 18 years at index treatment initiation or switch - Starting treatment with abatacept or new disease-modifying anti-rheumatic drug (including switching or adding) or biologic disease modifying drug. - Read/write English Exclusion Criteria:

Additional Information

Official title An Observational Cohort to Assess Safety and Outcomes in Patients Treated With Abatacept and Other Anti-Rheumatic Therapies
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.