Clinical trial · Observational
A Post-marketing Study on the Safety of Abatacept Treatment in Denmark Using the Danish Database
A Nationwide Post-marketing Study on the Safety of Abatacept Treatment in Denmark Using the DANBIO Register
NCT05421442CI-TRIAL-00098619DANBIOcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Psoriatic Arthritis (PsA) | — | UNRESOLVED | — |
| Rheumatoid Arthritis (RA) | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (3)
- label
- Abatacept Group
- description
- Participants with established rheumatoid arthritis (RA) or psoriatic arthritis (PsA) and receiving abatacept
- label
- Non-targeted Disease Modifying Anti-rheumatic Drug (DMARD) Group
- description
- 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
- label
- Targeted DMARD Group
- description
- Participants with established RA or PsA and previously treated without abatacept who start treatment with targeted DMARDs
Primary outcomes (5)
- measure
- Incidence Rates of Overall Malignancies
- timeFrame
- Up to 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.