Effect of Adalimumab on Inflammatory Activity in Atherosclerotic Lesions in Patients with Reumatoid Arthritis

Effect of Adalimumab on Inflammatory Activity in Atherosclerotic Lesions in Patients with Reumatoid Arthritis - Adalimumab and Inflammation of Atherosclerotic Lesions

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON41532

Enrollment

Registered

2010-12-23

Start date

2011-09-28

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age older than 45 years - Both males and females - Patients with active RA (DAS28 score >4.0)

Exclusion criteria

Exclusion criteria: - Hypersensitivity to the active substance or to any of the excipients.' - Gebruik van corticosteroiden - Zwangerschap of zwangerschapswens - Active tuberculosis or other severe infections such as sepsis, and opportunistic infections. - Moderate to severe heart failure (NYHA class III/IV) - Cancer, limited life expectancy

Design outcomes

Primary

Measure	Time frame
1] baseline difference in 18-FDG uptake in large arteries using Positron Emission Tomography in RA patients versus controls. 2] changes in 18-FDG uptake in large arteries induced by methotrexate and adalimumab (Humira) in a 3-4 month treatment window	—

Secondary

Measure	Time frame
1] changes in IMT 6, 12 and 24, 36, 48 and 60 months following anti-inflammatory treatment with methotrexate or adalimumab (Humira)	—

Countries

Netherlands

Outcome results