CClinicalTrials.gg
CompletedNCT05413044Updated Dec 8, 2025

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

An observational study in Rheumatoid Arthritis and Psoriatic Arthritis, sponsored by Bristol-Myers Squibb. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-08.

Sponsored by Bristol-Myers Squibb · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
140,706
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Rheumatoid Arthritis
  • Psoriatic Arthritis

Keywords

  • Abatacept
  • Orencia
  • Malignancies
  • Long-term safety follow-up
03

In context

Arthritis, Rheumatoid

2,888 studies on the registry are indexed under Arthritis, Rheumatoid; 390 are open to participants now.

This study's enrollment of 140,706 is above the median of 176 across 824 observational studies indexed under Arthritis, Rheumatoid.

Browse Arthritis, Rheumatoid studies →

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Participants with RA or PsA who began abatacept, a non-targeted DMARD, or a targeted DMARD enrolled in the SRQ Register between January 2007 and January 2021.

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

Exclusion Criteria:

- Not applicable

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
140,706 participants (actual)
Patient registry
No

Groups and cohorts

  • Abatacept Group

    Participants with established RA or 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 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.

06

What researchers measure

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

07

Study locations

1 site
  • Local Institution
    Princeton, New Jersey 08540, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05413044
Lead sponsor
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
Jun 9, 2022
Start date
Jul 1, 2019
Primary completion
Aug 22, 2025
Completion
Oct 31, 2025
Last update
Dec 8, 2025

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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