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Rheumatoid Arthritis Handscanner Observational Study

Rheumatoid Arthritis Handscanner Observational Study - RA-HOS

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON37927
Enrollment
70
Registered
2011-12-21
Start date
2012-01-09
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

Arthritis Rheumatoid Arthritis

Interventions

None listed

Sponsors

Akeso Medical Imaging BV
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. diagnosis of Rheumatoid Arthritis (or artralgia for control group) 2. No significant visual deformations of the hand and fingers 3. Patients between the age of 18 and 90 years 4. Ability to give informed consent

Exclusion criteria

Exclusion criteria: - Recent surgery or operation, in the last three months, on the wrist, hand or fingers - Allergy to gadolinium contrast (only for subgroup) - Metal objects in any organ or joint (only for subgroup) - Claustrofobia (only for subgroup) - Estimated creatinine clearance by MDRD

Design outcomes

Primary

MeasureTime frame
- To collect data to develop a diagnostic model (algorithm) based on the optical transmission measurements performed by the FHP that can predict the joint inflammation level as assessed by currently accepted methods, such as DAS28, ultrasound, MRI, blood tests and questionnaires. - To evaluate in a cross-sectional study (part I) the level of agreement between predictions of disease activity from optical spectral transmission measurements (algorithm) and conventional disease activity measurements in rheumatoid arthritis patients, i.e. ultrasound, magnetic resonance imaging (MRI), physical examination by a physician (number of swollen and tender joints), blood tests and questionnaires. - To evaluate in a longitudinal study (part II) the correlation between (changes in) optical spectral transmission measurements and DAS28 measurements in patients with severe RA in the cross-sectional part during 6 months.

Secondary

MeasureTime frame
To assess the influence of variables on optical transmission measurements: • Erosions and destruction in joints of the hands and wrists • skin temperature and type • wounds • vasodilatative medication • vasoconstrictive diseases like Raynauds disease

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)