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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05421442

Acronym

DANBIO

Enrollment

38396

Registered

2022-06-16

Start date

2019-06-13

Completion date

2025-10-31

Last updated

2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriatic Arthritis (PsA), Rheumatoid Arthritis (RA)

Keywords

Abatacept, Orencia, Malignancies, Long-term safety follow-up

Brief summary

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

United States

Outcome results