Let's Talk Trials!
Question #2
Question: How much can it cost as far as travel, meds, etc. and if someone qualifies, how do they quantify if the meds are working?
Submitted by: HF
Answer: Dear HF,
We are glad you visited the Lupus Research Institute National Coalition program “Lupus Together for Clinical Trials” at www.LupusTrials.org. Your question highlights a concern of many people considering participation in a clinical trial.
Typically, when someone participates in a clinical trial, all study related costs are covered by the sponsoring pharmaceutical company. In fact, a participant may be compensated a certain amount at the end of the trial for each visit completed to help cover some travel expenses.
The physician in charge of the study will complete questionnaires at each study visit to track a patient's progress. Safety evaluations, such as physical exams and lab tests, are also performed. While there is no guarantee that a study medication will work for a participant (especially when a placebo is involved), all volunteers can be excited to know that they are helping to advance our understanding of a very complex disease. We need better and safer drugs for the treatment of lupus!
You can find out more information at http://www.lupustrials.org/what/index.php and http://www.lupustrials.org/steps/index.php.
Laura Donohue, CCRC
Senior Research Coordinator
Division of Rheumatology and Allergy–Clinical Immunology
North Shore – LIJ Health System
Question #1
Question: I was wondering if anyone had done the Rituximab treatment for lupus, and if they did what was the outcome? My doctors want me to do those treatments, but I can only find trials done on cancer patients.
From a reader in Honolulu, Hawaii
Answer: Although rituximab (Rituxan) was approved in 1999 for the treatment of lymphoma and more recently for the treatment of rheumatoid arthritis, this drug is not approved for the treatment of SLE. However, since rituximab can be obtained from a pharmacy, doctors can potentially administer it to a patient with SLE. Use for an unapproved indication is known as “off-label” use. Doctors might consider use of rituximab when conventional therapies have failed. However, there may be legal and/or financial constraints in using a drug off-label.
Approximately 10-15,000 patients worldwide have received rituximab off-label. In addition, there have been many small studies of rituximab in SLE. Two large studies of rituximab in SLE are being sponsored by Genentech and BiogenIdec. In fact, the preliminary results from one study were just released. This study failed to show improvement of SLE activity when Rituxan was compared to placebo. It is very important to emphasize that a failed study does not necessarily mean the drug is ineffective. A detailed analysis of the data will be performed. You need to discuss the potential benefits and risks with your doctor. Stay tuned!
This posting of “Question of the Week” was answered by:
Richard Furie, MD
Chief, Division of Rheumatology and Allergy-Clinical Immunology
North Shore – Long Island Jewish Health System
Director, SLE and Autoimmune Disease Treatment Center
Professor of Clinical Medicine, Albert Einstein College of Medicine
Although every effort is made to make clinical trials as safe as possible, the trials that test new therapies are essentially experiments.