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Rheumatoid Arthritis Disease Activity Monitor

Completed
Conditions
RA
Rheumatoid Arthritis
10023213
Registration Number
NL-OMON33746
Lead Sponsor
Philips
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
75
Inclusion Criteria

Diagnosed with Rheumatoid Arthritis
Inflamed PIP joint of at least one index finger (moderate or severe)
Disease activity of specific joints known (swelling, tenderness)
No significant deformations of the hand or fingers
More than 18 years old

Exclusion Criteria

Recent surgery or operation, in the last three months, on the arm or fingers that will be tested with the RADAM RRC.
Inability to give informed consent

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Primary endpoint is a successful measurement of optical attenuation of a joint<br /><br>and the part of the finger next to the joint before, during and after two<br /><br>consecutive restrictions of venous blood flow by means of a pressure cuff.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Secondary endpoints are unsuccessful measurements related to early termination<br /><br>of the measurement related to patient discomfort or safety and equipment or<br /><br>software failure.</p><br>
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