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

Positron emission tomography with macrophage targeting to select individuals at risk for rheumatoid arthritis. - PET for early diagnostics in RA

Status
Recruiting
Phases
Phase 2
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON46692
Enrollment
60
Registered
2018-05-28
Start date
2018-11-27
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

arthritis rheumatoid arthritis

Interventions

The study will involve a baseline whole body macrophage PET-CT scan follow by a clinical follow-up period of one year to assess development of clinical arthritis at 3, 6, 9 and 12 months.

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

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

Secondary

MeasureTime frame
Not applicable.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)