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Quantitative kinetic analysis of [11C]DPA-713 and [18F]PEG-Folate uptake in joints of patients with rheumatoid arthritis

Quantitative kinetic analysis of [11C]DPA-713 and [18F]PEG-Folate uptake in joints of patients with rheumatoid arthritis - [11C]DPA-713 and [18F]PEG-Folate in rheumatoid arthritis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON45561
Enrollment
6
Registered
2016-12-21
Start date
2017-05-09
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

arthritis rheumatoid arthritis

Interventions

Not applicable.

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Men and women, * 18 years of age. * 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. * Patients with obvious clinical arthritis activity assessed by a physician, in at least 1 hand, wrist of knee joints. * Treatment with disease modifying anti-rheumatic drugs (DMARDS), biologics 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. * Patients must be able to adhere to the study appointments and other protocol requirements. * 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: * Use of intramuscular or intravenous corticosteroids within 4 weeks prior to screening. * Treatment with any investigational drug within the previous 3 months. * Pregnancy or breast-feeding * Anemia (Hemoglobine

Design outcomes

Primary

MeasureTime frame
Development of a tracer kinetic model for tracers [11C]DPA-713 and [18F]PEG-Folate.

Secondary

MeasureTime frame
1. Development of a static imaging protocol and a validated simplified measure for quantification of uptake of tracers [11C]DPA-713 and [18F]PEG-Folate in arthritic joints in RA patients. 2. Comparison of the static and kinetic model, leading to simplification of protocols for routine clinical studies.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)