Trial Participant Stories
I was diagnosed with lupus in 1980 after numerous blood tests and physical manifestations, including joint pain, rashes, fever and fatigue. I was treated with Plaquenil, an anti-malarial drug, and ibuprofen to reduce the joint pain. These drugs were developed to treat other diseases—not lupus.
Several years later, I began to excrete about 12,000 grams of protein in my urine every day. To control this massive protein loss, which could ultimately cause irrevocable damage to my kidney functioning, and after an unsuccessful kidney biopsy that damaged my gall bladder, I was given extremely high doses of corticosteroids to reduce the inflammation in my kidneys and elsewhere in my system.
Over the next 20 years I endured numerous critical conditions as a result of lupus, including 70% kidney failure, joint inflammation, pulmonary blood clots, hemorrhaging, pleurisy and skin rashes. In an effort to control these life-threatening conditions, I have been treated with many off label drugs such as intravenous Cytoxin, Immuran, and Cellcept—all chemotherapy drugs used traditionally for cancer treatment or renal transplants—as well as massive intravenous corticosteroids, Vasotec, oral steroids, and Plaquenil. At any given time I was taking from 5 to 10 different medications.
In 1997, my physician, Dr. Richard Furie introduced me to a phase II, double blind trial of LJP 394, a drug under development for the treatment of patients with lupus kidney disease such as myself. The goal of this clinical study was to determine whether its administration could prevent or delay flares of lupus nephritis. By that time, I had already experienced two severe lupus nephritis attacks requiring hospitalization and intravenous chemotherapy drugs. Needless to say, I was extremely interested in attacking this disease with a novel approach.
So why, you may ask, would I agree to participate in a Phase II, double blind study slated to last approximately 2 years? After all, I am essentially the subject of an experiment involving research of an unproven drug requiring weekly visits for an infusion into my veins. Furthermore, after committing to the study, there was a fifty-fifty chance that I would be receiving a placebo which is no treatment at all. Looking back now, the answer is simple as to why I agreed, without hesitation, not once but twice to participation in this clinical trial as well as the study extensions that followed.
FIRST & FOREMOST: I was fortunate in that my physician was the principal investigator of this study—and I had an enormous level of trust in his judgment. Once accepted into the study, lab tests would be conducted monthly and questionnaires completed documenting any physical changes. I felt confident that an adverse reaction to the drug and/or progression of my disease would be caught in adequate time. Looking back, my instincts were correct. I received the highest level of care and monitoring during the study and well beyond.
SECOND: Before making my final decision to join the study, I needed to know that participating in it would not be tantamount to signing a binding contract. Several important concerns were that I be permitted to continue taking my medications while participating and that there would be a sufficient amount of flexibility in the weekly schedule for my personal needs.
Equally important was that I have the right to leave the study at any time for any reason or no reason—and without any penalty. The informed consent agreement, required by the FDA in all clinical trial studies, discloses this right to withdraw as well as all material information concerning the trial. It must be written in an understandable format. Before I signed the consent, the doctor and I discussed all my concerns thoroughly so that I walked away with a firm understanding of what I was committing to.
LAST BUT NOT LEAST: I resolved that if I was to be cured of systemic lupus nephritis, partaking in a clinical trial offered me the chance to take matters into my own hands and attack this dangerous and debilitating autoimmune disease rather than continue to allow it to attack me.
I am pleased to say that I do not qualify for the current LJP study as I have been in remission for over 6 years. But I would not hesitate to participate again, if I could, because the only way to find the cure to lupus is to participate in clinical drug trials.