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

NCT ID: NCT05421442

Last Updated: 2025-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

38396 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-13

Study Completion Date

2025-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rheumatoid Arthritis (RA) Psoriatic Arthritis (PsA)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Abatacept Group

Participants with established rheumatoid arthritis (RA) or psoriatic arthritis (PsA) and receiving abatacept

No interventions assigned to this group

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

No interventions assigned to this group

Targeted DMARD Group

Participants with established RA or PsA and previously treated without abatacept who start treatment with targeted DMARDs

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Local Institution - 0001

Lawrenceville, New Jersey, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EUPAS31532

Identifier Type: REGISTRY

Identifier Source: secondary_id

IM101-803

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.