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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON41460
Enrollment
18
Registered
2013-06-28
Start date
2013-11-29
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

rheumatoid arthritis

Interventions

None listed

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Standardized uptake values (SUV) in arthritic joints Target-to-background ratio (i.e uptake in arthritic joints divided by uptake in peri-articular tissue).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)