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

Completed

• Conditions: Arthritis; Inflammatory Arthritis; 10003816; 10013317; 10003216

• Registration Number: NL-OMON41532
• Lead Sponsor: Jan van Breemen Instituut/Reade

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2020-07-10
• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 90

Inclusion Criteria

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

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 <12 months

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1] baseline difference in 18-FDG uptake in large arteries using Positron<br /><br>Emission Tomography in RA patients versus controls.<br /><br><br /><br>2] changes in 18-FDG uptake in large arteries induced by methotrexate and<br /><br>adalimumab (Humira) in a 3-4 month treatment window </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1] changes in IMT 6, 12 and 24, 36, 48 and 60 months following<br /><br>anti-inflammatory treatment with methotrexate or adalimumab (Humira)</p><br>