The present clinical study is part of the development and evaluation of the Full Hand Proto (FHP) to measure disease activity in the joints of hands and wrists of rheumatoid arthritis patiens based on optical attenuation measurements.
ID
Source
Brief title
Condition
- Autoimmune disorders
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- 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 outcome
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
Background summary
Treatment-decisions in patients with rheumatoid arthritis are usually based on
DAS-28, a composite measure consisting of measurements from physical
examination (swollen and tender joint counts), patient reported outcomes and
laboratory results. It is well known that there may be disease activity despite
of remission measured by DAS-28, and further that DAS-28 is influenced by
factors unrelated to activity of rheumatoid arthritis. An increasing need is
felt for objective measuments of disease activity. Currently, more and more
ultrasound and MRI are applied for this goal. Both have several drawbacks, for
example ultrasound is operator-dependent and MRI is expensive. Optical
transmission spectroscopy offers several advantages over these existing
modalities; it is operator-independent, its costs are relatively low and it is
harmless at relevant wavelengths and intensities. A new device, the Full Hand
Proto (FHP) has been realized by Philips Research. This device can assess all
joints in hands and wrists. Preliminary results in a recent pilot study
showed good correlation between clinical assement of disease activity.
Study objective
The present clinical study is part of the development and evaluation of the
Full Hand Proto (FHP) to measure disease activity in the joints of hands and
wrists of rheumatoid arthritis patiens based on optical attenuation
measurements.
Study design
Part I is a cross sectional, nonrandomized observational study in patients with
rheumatoid arthritis (RA). Part II is a follow-up longitudinal observational
study in patients selected from study part one with severe RA. We will evaluate
in a cross-sectional study (part I) the level of agreement between predictions
of disease activity from optical spectral transmission measurements 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. We will 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. All subjects will receive treatment as usual throughout the
study.
Study burden and risks
Patients will have to pay an extra visit to the hospital. The measurements will
take 3 hours (4 in case of MRI). The risks are small, in the subgroup in which
MRI will be performed there is small risk of allergy to the gadolinium
contrasts. In the subgroup with high disease activity will be asked at their
regular doctors appointment to undergo optical transmission measurements and
fill out questionaires. This will take an estimated 20 minutes per month during
6 months. The study may benefit future patients with reumatoid arthritis,
because with the Hand Scan Pro hopefully a better estimate of disease activity
may be obtained.
Torenallee 20
5617 BC Eindhoven
NL
Torenallee 20
5617 BC Eindhoven
NL
Listed location countries
Age
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
- 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 < 30 ml/min (only for subgroup)
- Patients in a wheelchair
- Pregnancy or breastfeeding
- Light sensitivity, i.e. Erythropoietic protoporphyria
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL34559.041.10 |