Rheumatoid Arthritis (RA)DANBIONCT05421442
A Post-marketing Study on the Safety of Abatacept Treatment in Denmark Using the Danish Database
An observational study of Rheumatoid Arthritis (RA) and Psoriatic Arthritis (PsA), run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA)
- How many people
- 38,396 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2019to 31 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult participants with RA or PsA who are enrolled in the Danish Database for Biologic Therapies (DANBIO) register in Denmark and were receiving abatacept, non-targeted DMARDs, or targeted DMARDs between January 2007 and December 2021.
Who may be able to join
- Diagnosis of rheumatoid arthritis (RA) or psoriatic arthritis (PsA)
- Receiving treatment with abatacept
- Receiving treatment with non-targeted DMARD
- Receiving treatment with targeted DMARD
Who cannot join
- -Not applicable
Trial locations and contacts
1 site in 1 country.
United States1 site
Local Institution - 0001
Lawrenceville, New Jersey, 08543
About this study
Official title: A Nationwide Post-marketing Study on the Safety of Abatacept Treatment in Denmark Using the DANBIO Register
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).
- Keywords
- Abatacept, Orencia, Malignancies, Long-term safety follow-up
- Medical subject headings
- Arthritis, Rheumatoid, Arthritis, Psoriatic, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Abatacept Group | Participants with established rheumatoid arthritis (RA) or psoriatic arthritis (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 disease modifying anti-rheumatic drugs (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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence Rates of Overall Malignancies
Measured: Up to 5 years
Incidence Rates of Melanoma
Measured: Up to 5 years
Incidence Rates of Non-melanoma Skin Cancer
Measured: Up to 5 years
Incidence Rates of Basal Cell Carcinoma
Measured: Up to 5 years
Incidence Rates of Squamous Cell Carcinoma
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start13 Jun 2019
- Primary completion22 Aug 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RA)Studies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 38,396 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05421442
- Sponsor's protocol ID
- IM101-803
- Other IDs
- EUPAS31532
- Acronym
- DANBIO
- Status last verified
- Dec 2025
- First submitted
- 13 Jun 2022
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Nationwide Post-marketing Study on the Safety of Abatacept Treatment in Denmark Using the DANBIO Register
- ClinicalTrials.gov ID
- NCT05421442
- Acronym / sponsor ID
- DANBIO / IM101-803
- Keywords
- Abatacept, Orencia, Malignancies, Long-term safety follow-up
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38,396 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 13 Jun 2019 (actual)
- Primary completion
- 22 Aug 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 16 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Abatacept Group | – | –Participants with established rheumatoid arthritis (RA) or psoriatic arthritis (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 disease modifying anti-rheumatic drugs (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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants with RA or PsA who are enrolled in the Danish Database for Biologic Therapies (DANBIO) register in Denmark and were receiving abatacept, non-targeted DMARDs, or targeted DMARDs between January 2007 and December 2021.
Key inclusion criteria (4 listed)
- Diagnosis of rheumatoid arthritis (RA) or psoriatic arthritis (PsA)
- Receiving treatment with abatacept
- Receiving treatment with non-targeted DMARD
- Receiving treatment with targeted DMARD
Key exclusion criteria (1 listed)
- -Not applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence Rates of Overall Malignancies
Time frame: Up to 5 years
Incidence Rates of Melanoma
Time frame: Up to 5 years
Incidence Rates of Non-melanoma Skin Cancer
Time frame: Up to 5 years
Incidence Rates of Basal Cell Carcinoma
Time frame: Up to 5 years
Incidence Rates of Squamous Cell Carcinoma
Time frame: Up to 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- BMS Clinical Trial InformationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis (RA) and Psoriatic Arthritis (PsA), run by Bristol-Myers Squibb at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence Rates of Overall Malignancies (time frame: Up to 5 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.