A Post-marketing Study on the Safety of Abatacept Treatment in Denmark Using the Danish Database (DANBIO)

December 2, 2025 updated by: Bristol-Myers Squibb

A Nationwide Post-marketing Study on the Safety of Abatacept Treatment in Denmark Using the DANBIO Register

The purpose of this study is to expand on the ongoing post-marketing monitoring of abatacept to include all participants with rheumatoid arthritis (RA) and psoriatic arthritis (PsA) treated with abatacept captured in Danish Database for Biologic Therapies (DANBIO).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

38396

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- New Jersey
  - Lawrenceville, New Jersey, United States, 08543
    - Local Institution - 0001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Adult participants with RA or PsA who are enrolled in the Danish Database for Biologic Therapies (DANBIO) register in Denmark and were receiving abatacept, non-targeted DMARDs, or targeted DMARDs between January 2007 and December 2021.

Description

Inclusion Criteria:

Diagnosis of rheumatoid arthritis (RA) or psoriatic arthritis (PsA)
Receiving treatment with abatacept
Receiving treatment with non-targeted DMARD
Receiving treatment with targeted DMARD

Exclusion Criteria:

-Not applicable

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Abatacept Group Participants with established rheumatoid arthritis (RA) or psoriatic arthritis (PsA) and receiving abatacept
Non-targeted Disease Modifying Anti-rheumatic Drug (DMARD) Group Participants with established RA or PsA and not previously treated with any targeted disease modifying anti-rheumatic drugs (DMARDs) and who start treatment with a non-targeted DMARD
Targeted DMARD Group Participants with established RA or PsA and previously treated without abatacept who start treatment with targeted DMARDs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence Rates of Overall Malignancies Time Frame: Up to 5 years	Up to 5 years
Incidence Rates of Melanoma Time Frame: Up to 5 years	Up to 5 years
Incidence Rates of Non-melanoma Skin Cancer Time Frame: Up to 5 years	Up to 5 years
Incidence Rates of Basal Cell Carcinoma Time Frame: Up to 5 years	Up to 5 years
Incidence Rates of Squamous Cell Carcinoma Time Frame: Up to 5 years	Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

BMS Clinical Trial Information

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 13, 2019

Primary Completion (Actual)

August 22, 2025

Study Completion (Actual)

October 31, 2025

Study Registration Dates

First Submitted

June 13, 2022

First Submitted That Met QC Criteria