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

NCT05413044 | Completed

• 1 other identifier: IM101-816
• Study Type: observational
• Target: 140,706
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rheumatoid Arthritis; Psoriatic Arthritis

Keywords

Abatacept; Orencia; Malignancies; Long-term safety follow-up

Outcome Measures

Primary Outcomes (5)

• Incidence Rate of Overall Malignancies

  5 years

• Incidence Rate of Melanoma

  5 years

• Incidence Rate of Non-melanoma Skin Cancer

  5 years

• Incidence Rate of Basal Cell Carcinoma

  5 years

• Incidence Rate of Squamous Cell Carcinoma

  5 years

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Diagnosis of RA or PsA
• ≥18 years at index treatment initiation
• Participants starting treatment with:
• abatacept
• non-targeted DMARDs
• targeted DMARD

You may not qualify if:

• \- Not applicable

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution

Princeton, New Jersey, 08540, United States

Location

Related Links

• BMS Clinical Trial Information

MeSH Terms

Conditions

Arthritis, Rheumatoid; Arthritis, Psoriatic; Neoplasms

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: June 9, 2022
• Study Start: July 1, 2019
• Primary Completion: August 22, 2025
• Study Completion: October 31, 2025
• Last Updated: December 8, 2025

Record last verified: 2025-12

Locations

US (1)