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OpenTrials
Completed

NCT Number: NCT05413044

A Post-marketing Study to Assess the Safety of Abatacept in Sweden Using the Swedish Rheumatology Quality Register (SRQ) Register

The purpose of this study is to collect real-world data in order to estimate the frequency of overall malignancies, melanoma, basal cell carcinoma, and squamous cell carcinoma in participants with rheumatoid arthritis (RA) or psoriatic arthritis (PsA) enrolled in the SRQ Register in Sweden.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Psoriatic Arthritis, Rheumatoid Autoimmune Diseases Bone Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Neoplasms Psoriasis Psoriatic Arthritis 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

Princeton, New Jersey, 08540, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of RA or PsA
  • ≥18 years at index treatment initiation
  • Participants starting treatment with:
  • abatacept
  • non-targeted DMARDs
  • targeted DMARD

Exclusion criteria

  • Not applicable

Treatment and study plan

Primary outcomes

  1. Incidence Rate of Overall Malignancies

    Time frame: 5 years

  2. Incidence Rate of Melanoma

    Time frame: 5 years

  3. Incidence Rate of Non-melanoma Skin Cancer

    Time frame: 5 years

  4. Incidence Rate of Basal Cell Carcinoma

    Time frame: 5 years

  5. Incidence Rate of Squamous Cell Carcinoma

    Time frame: 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 Sweden Using the SRQ Register

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Jun 9, 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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