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NCT05413044 Clinical Trial

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

Rheumatoid Arthritis Clinical Trial

Official title:
A Nationwide Post-Marketing Study on the Safety of Abatacept Treatment in Sweden Using the SRQ Register

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05413044
Other study ID # IM101-816
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date July 1, 2019
Est. completion date May 1, 2025

Study information
Verified date June 2022
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 4300
Est. completion date May 1, 2025
Est. primary completion date May 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Local Institution Princeton New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence Rate of Overall Malignancies 5 years
Primary Incidence Rate of Melanoma 5 years
Primary Incidence Rate of Non-melanoma Skin Cancer 5 years
Primary Incidence Rate of Basal Cell Carcinoma 5 years
Primary Incidence Rate of Squamous Cell Carcinoma 5 years
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