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OpenTrials
Completed

NCT Number: NCT05421442

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

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).

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Key information

Conditions

Rheumatoid Arthritis (RA) Arthritis Arthritis, Psoriatic Arthritis, Rheumatoid Autoimmune Diseases Bone Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Neoplasms Psoriasis Psoriatic Arthritis (PsA) Rheumatic Diseases Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution - 0001

Lawrenceville, New Jersey, 08543, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Incidence Rates of Overall Malignancies

    Time frame: Up to 5 years

  2. Incidence Rates of Melanoma

    Time frame: Up to 5 years

  3. Incidence Rates of Non-melanoma Skin Cancer

    Time frame: Up to 5 years

  4. Incidence Rates of Basal Cell Carcinoma

    Time frame: Up to 5 years

  5. Incidence Rates of Squamous Cell Carcinoma

    Time frame: Up to 5 years

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Acronym: DANBIO

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Jun 16, 2022
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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