PET imaging of arthritis by specific macrophage targeting in Rheumatoid Arthritis patients - clinical proof of concept studies

Completed

Conditions: rheumatoid arthritis
10003816
10023213

Registration Number: NL-OMON41460

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 18

Inclusion Criteria

1. Men or women, * 18 years old
2. Diagnosis of rheumatoid arthritis according to the 1987 revised criteria of the American Rheumatism Association (ARA) and/or the 2010 ACR/EULAR Rheumatoid Arthritis Classification Criteria.
3. Patients with obvious clinical arthritis activity assessed by a physician, in at least 2 hand, wrist or knee joints.
4. Treatment with disease modifying anti-rheumatic drugs (DMARDS) and oral corticosteroids up to 10 mg daily is allowed. Non-steroidal anti-inflammatory drugs (NSAID) is permitted, provided that there is a stable dose for at least 1 month. Furthermore, prior or current treatment with biologics is permitted, provided that there is a stable dosing schedule for at least 3 months.
5. Patients must be able to adhere to the study appointments and other protocol
requirements.
6. Patients must be capable of giving informed consent and the consent must have been
obtained prior to the study related procedures.

Exclusion Criteria

1. Use of intramuscular or intravenous corticosteroids within 4 weeks prior to screening.
2. Treatment with any investigational drug within the previous 3 months.
3. Pregnancy or breast-feeding.
4. Previous exposure to radioactivity with a yearly cumulative dose of * 5 mSv.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Standardized uptake values (SUV) in arthritic joints<br /><br>Target-to-background ratio (i.e uptake in arthritic joints divided by uptake in<br /><br>peri-articular tissue). </p><br>

Secondary Outcome Measures