Safety Study of Abatacept to Treat Rheumatoid Arthritis (B)

Rheumatoid Arthritis Clinical Trial

Official title:

An Observational Cohort to Assess Safety and Outcomes in Patients Treated With Abatacept and Other Anti-Rheumatic Therapies

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01088360
• Other study ID #: IM101-045B
• Status: Active, not recruiting
• Start date: March 31, 2005
• Est. completion date: June 30, 2029

Study information

• Verified date: January 2019
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20000
• Est. completion date: June 30, 2029
• Est. primary completion date: June 30, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	National Data Bank for Rheumatic Diseases (NDB)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Key safety outcomes (targeted infections, malignancies, mortality)		Every 6 months throughout the study
Secondary	Patient-reported infusion reactions		Every 6 months throughout the study
Secondary	Multiple sclerosis, lupus, and psoriasis		Every 6 months throughout the study
Secondary	Adverse events in pregnant women who receive abatacept		Every 6 months throughout the study
Secondary	Adverse events in subjects on abatacept who receive concomitant biologics		Every 6 months throughout the study

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form