Positron emission tomography with macrophage targeting to select individuals at risk for rheumatoid arthritis.

Phase 2

Recruiting

• Conditions: arthritis; rheumatoid arthritis; 10003816; 10023213

• Registration Number: NL-OMON46692
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

1. Patients must be 18 years of age or older
2. Patients must be diagnosed with arthralgia (not secondary to trauma) by a physician
3. Patients must have a positive ACPA blood test
4. Patients must be able to adhere to the study appointments and other protocol requirements.
5. Patients must be capable of giving informed consent and the consent must have been obtained prior to the study related procedures.

Exclusion Criteria

1. Arthritis and/or tenosynovitis as revealed by physical examination of 44 joints through the Disease Activity Score (DAS) (34) by 2 independent physicians
2. Previous corticosteroid injection in joints
3. Trauma involving joints in the 6 months prior to inclusion
4. Pregnancy or breast-feeding.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>The diagnostic performance (PPV, NPV, sensitivity and specificity) of<br /><br>quantitative whole body PET and macrophage targeting for development of<br /><br>clinical arthritis in ACPA positive arthralgia individuals during one year<br /><br>follow-up. Predictive ability of PET will be regarded as clinically relevant<br /><br>if the positive predictive value will be equal or more than 80%.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Not applicable.</p><br>