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

A Nationwide Post-Marketing Study on the Safety of Abatacept Treatment in Sweden Using the SRQ Register

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05413044

Enrollment

140706

Registered

2022-06-09

Start date

2019-07-01

Completion date

2025-10-31

Last updated

2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriatic Arthritis, Rheumatoid Arthritis

Keywords

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

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Incidence Rate of Overall Malignancies	5 years
Incidence Rate of Melanoma	5 years
Incidence Rate of Non-melanoma Skin Cancer	5 years
Incidence Rate of Basal Cell Carcinoma	5 years
Incidence Rate of Squamous Cell Carcinoma	5 years

Countries

United States

Outcome results