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NCT05421442 Clinical Trial

A Post-marketing Study on the Safety of Abatacept Treatment in Denmark Using the Danish Database

Rheumatoid Arthritis (RA) Clinical Trial

— DANBIO  

Official title:
A Nationwide Post-marketing Study on the Safety of Abatacept Treatment in Denmark Using the DANBIO Register

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05421442
Other study ID # IM101-803
Secondary ID EUPAS31532
Status Active, not recruiting
Phase
First received
Last updated
Start date June 13, 2019
Est. completion date July 31, 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 expand on the ongoing post-marketing monitoring of abatacept to include all participants with rheumatoid arthritis (RA) and psoriatic arthritis (PsA) treated with abatacept captured in Danish Database for Biologic Therapies (DANBIO).

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 1450
Est. completion date July 31, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

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 Rates of Overall Malignancies Up to 5 years
Primary Incidence Rates of Melanoma Up to 5 years
Primary Incidence Rates of Non-melanoma Skin Cancer Up to 5 years
Primary Incidence Rates of Basal Cell Carcinoma Up to 5 years
Primary Incidence Rates of Squamous Cell Carcinoma Up to 5 years
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