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

Completed

Conditions studied: Rheumatoid Arthritis

In brief

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?

Key facts

Study ID

NCT01098201

Run by

University of Rochester

People needed

5

Starts

2010-10-01

Expected to finish

2014-07-01

Last updated by the study team

2015-09-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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

Where it is running

• University of Rochester — Rochester, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.