Rheumatoid Arthritis Clinical Trial
Official title:
Rheumatoid Arthritis Disease Activity Monitor
Background of the study:
Rheumatoid Arthritis (RA) is an autoimmune disease. There are four stages of the disease:
1. Synovial inflammation
2. Swelling of synovium
3. Pannus formation
4. Advanced bone and cartilage destruction Currently, there is no cure for RA, making the
disease a chronic condition. RA is more prevalent in elderly and women. With medication
it is possible to delay the onset of complications. Over the last decade, the treatment
of RA has changed. Where treatment was palliative until pain medication was
ineffective, the treatment is now more aggressive with early administration of disease
modifying drugs (DMARDs).
The treatment for RA is staged. First, the patient receives generic, low-cost drugs. If this
treatment becomes ineffective, the treatment is adjusted with different and usually more
advanced drugs. Biologics are a category drugs that are considered most advanced and most
expensive.
For effective treatment, there are two unmet needs.
- A tool to aid early diagnosis, as this allows early treatment and delay of
complications and physical restrictions for patients.
- A safe, simple and cheap tool to monitor disease progress to allow traceable,
operator-independent informed decisions on treatment adjustments.
Non-invasive optical methods offer several advantages over existing modalities. Optical
contrast can be related to physiological parameters in the body, such as blood concentration
and oxygenation. At relevant wavelengths and intensities, optical radiation is completely
harmless. The cost of optical methods is low compared to other modalities. An important
application, where optical methods can help diagnosis and treatment is detection of
inflammation of joints in patients suffering from rheumatoid arthritis (RA). Due to the
highly scattering nature of tissue, non-invasive optical methods for medical imaging are
limited to the extremities of the human body. For application in joint diseases, this is
acceptable, because imaging of hands can provide sufficient clinical information.
Objective of the study:
Primary objectives:
This is a retrospective, nonrandomized controlled observational study, conducted in a single
center to evaluate the potential of optical attenuation measurements to establish disease
activity for rheumatoid arthritis patients.
Secondary objectives:
Establish parameters from transient optical transmission measurements of the joint that
relate to clinical evaluation results of individual joints Evaluate relation between disease
activity (DAS-28 score) and the optical attenuation spectra of the fingers of a patient.
Study design:
This is a cross sectional, nonrandomized controlled observational study, conducted in a
single center to evaluate the potential of optical attenuation measurements to establish
disease activity for rheumatoid arthritis patients.
Study population:
The subject population will be patients visiting the Regionaal Reuma Centrum Eindhoven for
rheumatoid arthritis. Patient visiting this center will represent a cross section of RA
patients that are taken care of in an outpatient setting.
Primary study parameters/outcome of the study:
Primary endpoint is a successful measurement of optical attenuation of a joint and the part
of the finger next to the joint before, during and after two consecutive restrictions of
venous blood flow by means of a pressure cuff.
Secondary study parameters/outcome of the study (if applicable):
Secondary endpoints are unsuccessful measurements related to early termination of the
measurement related to patient discomfort or safety and equipment or software failure.
n/a
Observational Model: Case-Only, Time Perspective: Cross-Sectional
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