Safety Study of Abatacept in Rheumatoid Arthritis Participants

Rheumatoid Arthritis Clinical Trial

Official title:

Comparative Safety of Biologic Disease-modifying Treatment Initiation With Abatacept in Rheumatoid Arthritis: A Real-world Population-based Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03696173
• Other study ID #: IM101-605
• Status: Completed
• Start date: December 17, 2015
• Est. completion date: June 29, 2018

Study information

• Verified date: September 2018
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A observational study to assess whether biologic disease-modifying (BDM) treatment initiation with abatacept for rheumatoid arthritis is associated with an increased risk of serious infection and cancer

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5800
• Est. completion date: June 29, 2018
• Est. primary completion date: June 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient initiates BDM treatment with at least one claim for the treatment. Patients will be presumed to be new users of a treatment if there is no claim for the drug or any other BDM in the 180 days prior to the cohort entry date

• Patient has at least two diagnoses for RA in the patient's history prior to and including the entry date or within the 180 days after the entry date

• Patient is aged 18 years or older on the entry date

• Patient was enrolled in the database for at least 180 days before the entry date

Exclusion Criteria:

• Patient is younger than 18 years on the entry date

• Patients who receive abatacept and another biologic simultaneously

• Patients who have an outcome diagnosis in the baseline period will be excluded from the cohort analyses for that outcome

Other protocol defined inclusion/exclusion criteria could apply

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Other:
• Non-Interventional
Non-Interventional
• Non-Interventional
Non-Interventional

Locations

Country	Name	City	State
United States	Local Institution	Princeton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of increased risk of serious infection while taking abatacept	With methotrexate	Approximately 7 years
Primary	Incidence of malignancy while taking abatacept	With methotrexate	Approximately 7 years
Primary	Incidence of increased risk of serious infection while taking abatacept	Without methotrexate	Approximately 7 years
Primary	Incidence of malignancy while taking abatacept	Without methotrexate	Approximately 7 years

External Links

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