Certolizumab and Lower Extremity Lymph Flow in Rheumatoid Arthritis (RA)

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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?

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Rochester
• Treatments: Certolizumab Pegol

Criteria

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