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Lupus is an urgent National Health problem affecting at least 1.5 million Americans yet existing treatments are inadequate. Many are toxic, suppress the entire immune system, and cause detrimental side effects over time. There has not been a drug developed specifically for lupus in nearly 5 decades so most treatments being used are borrowed from other diseases like Cancer. It is a costly multi-system disease as patients must regularly see several specialists and it can affect virtually any part of the body including vital organs making it the prototypical autoimmune disease. The benefits of lupus research could be promising for over 100 other autoimmune disorders, yet present funding for lupus research remains insufficient. Every member of the lupus community must join together to support increased research funding that will enable scientists to find the cause, develop precise diagnostic measures, discover safer, more effective treatments, and ultimately find the cure.
Lupus Foundation of Mid and Northern New York
President/CEO Kathleen Arntsen with Dr. Janet Woodcock,
FDA Director at the September 2007 LRI Annual Scientific
Meeting at the Yale Club in New York City
"Hope is on the Horizon"
Clinical Trial Research
for New Treatments
Aspreva Pharmaceuticals Seeks People with Lupus Nephritis
The Aspreva Lupus Management Study (ALMS)
is being conducted to assess the efficacy and
safety of mycophenolate mofetil (MMF) versus
standard therapy in inducing a response and
maintaining remission in patients with Lupus
Nephritis. The study involves two phases.
The first phase is a 6-month induction period
to initially treat Lupus Nephritis. If a response
is achieved, patients will then enter the second
phase which is a 3 year maintenance period.
This study is recruiting in approximately 40
centers across North America with a target
to enroll 100 patients. For more information,
please contact Aspreva's medical information
toll-free at 011-800 111-25252 or access the
study website at www.almstudy.com or
www.clinicaltrials.gov and search lupus nephritis.
Genentech Recruiting for Clinical Trial for Treatment of Lupus
Genentech’s EXPLORER study will enroll approximately 250 people with lupus at more than 55 centers nationwide. The Phase II/III study will focus on the safety and efficacy of rituximab (Rituxan®) compared with placebo when combined with a single stable background immunosuppressive medication in people with moderate to severe lupus.
The primary efficacy endpoint of the randomized, double blind, placebo-controlled trial will be evaluated at 52 weeks. EXPLORER is looking for participants who are currently diagnosed with SLE, between the ages of 16 and 75, and experiencing an active disease flare. Patients must be stable using one immunosuppressive drug, and not pregnant or nursing. For more information, call 1-800-597-4469 or go to www.lupustrial.com/lupus
La Jolla Pharmaceutical Company
Lupus Clinical Trial: an ongoing clinical trial entitled “A Randomized Double-blind, Placebo-controlled, Four-arm, Parallel-group, Multicenter, Multinational Safety and Efficacy Trial of 100mg and 300mg of LJP 394 in Systemic Lupus Erythematosus Patients with a History of Renal Disease." The primary purpose of this study is to determine whether LJP 394 is more effective than placebo in delaying time to renal flare in SLE patients with a history of renal disease.
www.clinicaltrials.gov/show/NCT00089804
Human Genome Sciences Advances Belimumab into Phase 3 Clinical Trials for Systemic Lupus Erythematosus
Human Genome Sciences (HGS) and GlaxoSmithKline (GSK) have initiated Phase 3 clinical trials of belimumab in Systemic Lupus Erythematosus (SLE). Belimumab is a human monoclonal antibody that specifically recognizes and inhibits the biologic activity of B-Lymphocyte stimulator, or BLyS®. The Phase 3 trials were designed by HGS in collaboration with GSK and leading international SLE experts, and aim to enroll more than 1600 patients with active SLE. This is understood to be the largest clinical trial program undertaken to-date researching a new drug in this disease. Human Genome Sciences has met with both the U.S. Food and Drug Administration (FDA) and the European Agency for the Evaluation of Medicinal Products (EMEA), and has received agreement on the major components of the Phase 3 program including the primary efficacy endpoint measures, target patient population and dose selection.
Human Genome Sciences is a biopharmaceutical company with a mission to apply great science and great medicine to deliver innovative drugs to patients with unmet medical needs. Early clinical and preclinical results to-date have demonstrated the potential efficacy and safety of belimumab, enabling progression to the Phase 3 program.
This Phase 3 development program will include two double-blind, placebo controlled, multi-center Phase 3 superiority trials, BLISS-52 and BLISS-76, which will evaluate the efficacy and safety of belimumab plus standard of care, versus placebo plus standard of care, in the treatment of patients with active SLE. BLISS (Belimumab International SLE Study) is looking to enroll patients that are at least 18 years old, have been diagnosed with lupus, and have been on stable treatment for the last month.
If you would like to learn more about the BLISS (Belimumab International SLE Study) studies, visit www.clinicaltrials.gov/show/NCT00410384 or call Human Genome Sciences at 1-866-447–9749.
Bristol-Myers Squibb
The purpose of this clinical research study is to learn whether Abatacept can treat and prevent lupus flares; specifically, active lupus flares in at least one of three organ systems: skin (discoid lesions), inflammation of the lining of the heart (pericarditis), or inflammation of the lining of the lung (pleuritis/pleurisy); or inflammation of more than 4 joints. All subjects will receive prednisone or prednisone-equivalent treatment in combination with study medication. The safety of this treatment will also be studied.
For more information: BMS Call Center 1-866-892-1BMS Ext. 175 or visit www.ClinicalTrials.gov/show/NCT00119678
"Hope is on the Horizon" Education Symposium Materials
Participating in Clinical Trials
LRI Patient Resource Guide for Clinical Trials
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