Rheumatoid Arthritis Disease Activity Monitor

NCT00989677 | Completed

• 2 other identifiers: NL2568201508Protocol 5014-080820
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Background of the study: Rheumatoid Arthritis (RA) is an autoimmune disease. There are four stages of the disease:

• 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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Rheumatoid Arthritis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maxima Medical Center: lead
• Philips Research Europe: collaborator

Study Sites (1)

Maxima Medical Centre

Eindhoven, 5600PD, Netherlands

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Ron NJ de Nijs, MD

  Maxima Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 2, 2009
• First Posted: October 5, 2009
• Study Start: January 1, 2009
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: October 5, 2009

Record last verified: 2009-10

Locations

NL (1)