Rheumatoid ArthritisNCT05413044
A Post-marketing Study to Assess the Safety of Abatacept in Sweden Using the Swedish Rheumatology Quality Register (SRQ) Register
An observational study of Rheumatoid Arthritis and Psoriatic Arthritis, run by Bristol-Myers Squibb at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Psoriatic Arthritis
- How many people
- 140,706 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 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: 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.
Who may be able to join
- Diagnosis of RA or PsA
- ≥18 years at index treatment initiation
- Participants starting treatment with:
- abatacept
- non-targeted DMARDs
- targeted DMARD
Who cannot join
- Not applicable
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Nationwide Post-Marketing Study on the Safety of Abatacept Treatment in Sweden Using the 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.
- Conditions
- Rheumatoid Arthritis, Psoriatic Arthritis
- 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 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence Rate of Overall Malignancies
Measured: 5 years
Incidence Rate of Melanoma
Measured: 5 years
Incidence Rate of Non-melanoma Skin Cancer
Measured: 5 years
Incidence Rate of Basal Cell Carcinoma
Measured: 5 years
Incidence Rate of Squamous Cell Carcinoma
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start1 Jul 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 ArthritisStudies 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
- 140,706 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
- NCT05413044
- Sponsor's protocol ID
- IM101-816
- Status last verified
- Dec 2025
- First submitted
- 7 Jun 2022
- Last updated
- 8 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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 Sweden Using the SRQ Register
- ClinicalTrials.gov ID
- NCT05413044
- Acronym / sponsor ID
- IM101-816
- Conditions
- Rheumatoid Arthritis, Psoriatic Arthritis
- Keywords
- Abatacept, Orencia, Malignancies, Long-term safety follow-up
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140,706 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 22 Aug 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 9 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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- Diagnosis of RA or PsA
- ≥18 years at index treatment initiation
- Participants starting treatment with:
- abatacept
- non-targeted DMARDs
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 Rate of Overall Malignancies
Time frame: 5 years
Incidence Rate of Melanoma
Time frame: 5 years
Incidence Rate of Non-melanoma Skin Cancer
Time frame: 5 years
Incidence Rate of Basal Cell Carcinoma
Time frame: 5 years
Incidence Rate of Squamous Cell Carcinoma
Time frame: 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 and Psoriatic Arthritis, 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 6 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 Rate of Overall Malignancies (time frame: 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.