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38,000 arthritis patients tracked: is abatacept safe Long-Term?

NCT ID NCT05421442

Knowledge-focused Sponsor: Bristol-Myers Squibb Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed study looked at the safety of the arthritis drug abatacept in over 38,000 people with rheumatoid or psoriatic arthritis in Denmark. Researchers used a national health registry to track rates of cancers and other side effects. The goal was to better understand the drug's real-world safety profile.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
abatacept
What this could lead to
If successful, this study could provide a clearer picture of the long-term safety of abatacept for arthritis patients.
What could go wrong
This is an observational study using registry data, not a controlled trial. It cannot prove cause and effect, and results may not apply to other populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

38,396 people

The number who actually took part.

Started

Jun 2019

Finished

Oct 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

neoplasm psoriatic arthritis rheumatoid arthritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Psoriatic arthritis (PSA) Rheumatoid arthritis (RA)

Contacts and locations

Locations

  • Local Institution - 0001

    Lawrenceville, New Jersey, 08543, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.