Rheumatoid Arthritis Clinical Trial
Official title:
The Effect of Certolizumab on Lower Extremity Lymph Flow in Rheumatoid Arthritis
Verified date | September 2015 |
Source | University of Rochester |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
This open-label pilot study will select subjects who are inadequate responders to
methotrexate. These subjects will receive certolizumab subcutaneously on a monthly basis for
six months. The study is attempting to determine the following:
1. Is lymphatic flow altered in the extremities of RA patients with an inflamed knee?
2. Is resolution of synovitis associated with a restoration of lymphatic flow and lymph
node volume following therapy with certolizumab?
3. Can Doppler ultrasound be used to detect and follow alterations of lymph node size?
Status | Completed |
Enrollment | 5 |
Est. completion date | July 2014 |
Est. primary completion date | July 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion - Inflammatory arthritis. Patients with RA according to the American College of Rheumatology criteria. - Inadequate response to treatment following 3 months of methotrexate (15-20 mg per week). Inadequate response will be defined as the presence of knee inflammation and at least 2 active joints. If the knee has an effusion, fluid must be obtained to exclude infection or crystalline disease. - Knee inflammation in one knee determined on physical exam and confirmed by Doppler ultrasound. We will include patients with bilateral knee inflammation only if one knee is more inflamed than the contralateral knee. The comparative level of inflammation will be determined by clinical examination and Doppler US. - Patients must be willing to undergo a sulfur colloid technetium scan, knee ultrasound and MRI of the knee. Exclusion Criteria - Contra-indication to anti-TNF agent. - History of recurrent infections. - Prosthetic knee joint - Recent surgery or trauma to a knee joint - Lymphedema - Lymphoproliferative disorder - Claustrophobia such that they cannot undergo an MRI of the knee - GFR<60 cc/min - Morbid obesity - Foot disease: active ankle or forefoot synovitis, recent trauma, cellulitis or edema. - Peripheral vascular disease - Diabetes - Active skin inflammation in the lower extremities - Solid Malignancy |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | University of Rochester | Rochester | New York |
Lead Sponsor | Collaborator |
---|---|
University of Rochester |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Initial lymphatic flow in inflamed knee | To examine the lymph flow in the knee joint of RA patients before therapy with certolizumab using technetium sulfur colloid scans, MRI and Doppler ultrasound. | Week 0 (initial medication dose) | No |
Primary | Initial synovitis and its association with lymph flow and node volume | To examine lymph flow and lymph node volume before therapy with certolizumab. Flow volume will be assessed using technetium sulfur colloid scans while lymph node volume will be assessed using MRI. | Week 0 (initial medication dose) | No |
Primary | Initial Doppler ultrasound assessment of lymph node size | To assess lymph node volume before therapy with certolizumab. | Week 0 (initial medication dose) | No |
Primary | Post medication lymphatic flow in inflamed knee | To examine lymph flow in the knee joint of RA patients after therapy with certolizumab using technetium sulfur colloid scans, MRI and Doppler ultrasound | Wk 18 | No |
Primary | Post medication synovitis and its association with lymph flow and node volume | To examine lymph flow and lymph node volume after therapy with certolizumab. Flow volume will be assesses using tecnetium sulfur colloid scan while lymph node volume will be assessed using MRI. | Wk 18 | No |
Primary | Post medication Doppler ultrasound assessment of lymph node size | To assess lymph node volume after therapy with certolizumab. | Wk 18 | No |
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