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

NCT ID: NCT05413044

Last Updated: 2025-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

140706 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-01

Study Completion Date

2025-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Rheumatoid Arthritis Psoriatic Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Abatacept Group

Participants with established RA or PsA and receiving abatacept.

No interventions assigned to this group

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.

No interventions assigned to this group

Targeted DMARD Group

Participants with established RA or PsA and previously treated without abatacept who start treatment with targeted DMARDs.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Princeton, New Jersey, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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IM101-816

Identifier Type: -

Identifier Source: org_study_id

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