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

Active, not recruiting

• Conditions: Rheumatoid Arthritis (RA); Psoriatic Arthritis (PsA)

• Registration Number: NCT05421442
• Lead Sponsor: Bristol-Myers Squibb

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-13
• Study First Submitted: 2022-06-13
• Study First Submitted QC: 2022-06-13
• Study First Posted: 2022-06-16
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-20
• Last Update Posted: 2025-06-25
• Primary Completion: 2025-09-04
• Study Completion: 2026-01-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1450

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Local Institution - 0001; 🇺🇸 Lawrenceville, New Jersey, United States