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

NCT05421442 | Completed

• 2 other identifiers: IM101-803EUPAS31532
• Study Type: observational
• Target: 38,396
• Locations: 1 country
• Sites: 1

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).

Conditions

Rheumatoid Arthritis (RA); Psoriatic Arthritis (PsA)

Keywords

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

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Not applicable

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution - 0001

Lawrenceville, New Jersey, 08543, United States

Location

Related Links

• BMS Clinical Trial Information

MeSH Terms

Conditions

Arthritis, Rheumatoid; Arthritis, Psoriatic; Neoplasms

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2022
• First Posted: June 16, 2022
• Study Start: June 13, 2019
• Primary Completion: August 22, 2025
• Study Completion: October 31, 2025
• Last Updated: December 8, 2025

Record last verified: 2025-12

Locations

US (1)