Lupus Clinical Trials

A clinical trial is a formal research study designed to test promising new treatments for a disease. A clinical trial follows a very specific protocol that has been reviewed by a variety of individuals and groups including the UCSF Committee on Human Research. Clinical trials are the final stage of the long process of drug design and development. Through participation in clinical trials, lupus patients can help their physicians bring effective and safe treatments for lupus into clinical use. For more detailed information on clinical trials, please visit the UCSF Committee on Human Research website at http://www.research.ucsf.edu/chr/index.asp

The clinical trial investigators at UCSF include Drs. David Wofsy, John Davis, Maria Dall'Era, Joann Gillis, and Laura Julian. We are currently conducting several important clinical trials of promising new agents in an effort to determine which may be most effective and safest for people with lupus. Patient participation in trials is vital to our success in bringing new therapies for lupus to daily clinical practice. If you are interested in learning more about clinical trials in lupus or about any of the trials listed below, please contact the UCSF Clinical Trials Center at (415) 502-1886.

Currently Enrolling Clinical Trials

Trial A: New Therapy in Mild Lupus
Anticipated Time Frame: 2005-2006
Objective: To test a potential new lupus therapy in patients with mild, controlled lupus
Investigators: Maria Dall'Era, MD and David Wofsy, MD
Main Eligibility Criteria:

• Mild lupus
• Treatment with prednisone and hydroxychloroquine (Plaquenil) is allowed
• Patients may not be currently treated with methotrexate, azathioprine (Imuran), mycophenolate mofetil (Cellcept), or cyclophosphamide (Cytoxan)

Contact Phone: 415-502-1886

Trial B: New Therapy in Patients Taking Cytoxan
Anticipated Time Frame: 2005-2006
Objective: To test a potential new therapy for patients who are currently receiving intravenous cyclophosphamide (Cytoxan) for active lupus.
Investigators: Joann Gillis, MD and David Wofsy, MD
Main Eligibility Criteria:

• Patients must be currently receiving Cytoxan or about to initiate a course of Cytoxan for active lupus

Contact Phone: 415-502-1886

Trial C: Cellcept in Patients with Cognitive Difficulties
Anticipated Time Frame: 2005-2007
Objective: To test the ability of mycophenolate mofetil (Cellcept) to improveproblems with memory, concentration, and thinking in lupus patients.
Investigators: Laura Julian, PhD and John Davis, MD, MPH
Main Eligibility Criteria:

• Patients must have problems with cognitive functioning (memory, concentration, thinking)
• Patients may not be currently treated with mycophenolate mofetil (Cellcept), methotrexate, azathioprine (Imuran), or cyclophosphamide (Cytoxan)

Contact Phone: 415-502-1886

Trial D: New Therapy for Patients with Lupus Kidney Disease
Anticipated Time Frame: 2005-2007
Objective: To test the safety and efficacy of anti-TNF therapy with etanercept in patients with lupus kidney disease.
Investigators: John Davis, MD, MPH and David Wofsy, MD
Main Eligibility Criteria:

• Patients should have kidney involvement from their lupus that is new or a recent flare
• Patients may be concurrently treated with azathioprine (Imuran) or mycophenolate mofetil (Cellcept)