Birmingham, AL (PRWEB) November 26, 2012
SLE is a chronic debilitating autoimmune disease that primarily affects young women of childbearing age, although men, children and teenagers also can develop lupus. SLE is characterized by the presence of autoreactive B cells resulting in elevated levels of autoantibodies, which directly damage the body’s cells and tissues or form immune complexes which cause inflammation and tissue damage. A range of organ systems may be involved simultaneously or sequentially.
The manifestations of lupus include arthritis, pleuritis, pericarditis, stroke, seizure, nephritis, vasculitis, anemia, thrombocytopenia, alopecia, photosensitivity, and malar rash. Over time, patients with lupus accrue irreversible organ damage which contributes to an increased mortality rate in these patients. Despite advances over the past 40 years in both diagnosis and treatment, patients with SLE have a 2 - 5-fold greater risk of mortality.
For more information about how to participate in this lupus clinical research study, visit Achieve Clinical Research or contact us directly at (205) 380-6434
RATIONALE FOR THE STUDY
The primary goal of lupus treatment is to control or halt the inflammatory disease process while minimizing the side effects and the risk of infection that are associated with current therapies. The treatments historically and currently used for SLE have broad effects on immune and inflammatory pathways. Standard therapies for SLE include corticosteroids, antimalarial agents, non-steroidal anti-inflammatory drugs, and immunosuppressive agents.
This is a global, multi-center, randomized, placebo-controlled study to evaluate adverse events of special interest in adults with active, autoantibody-positive systemic lupus erythematosus (SLE) treated with a new drug plus standard therapy vs placebo plus standard therapy.
The objectives of this study are to evaluate the following in adult SLE subjects receiving the new drug plus standard therapy versus subjects receiving placebo plus standard therapy:
Subjects enrolled in the study must meet the following inclusion criteria:
1. Males or females ≥ 18 years.
2. Have a diagnosis of SLE, refer to ACR revised criteria for the classification of SLE as a guide for diagnosis of SLE.
3. Active, autoantibody positive SLE (autoantibody positive is defined as the presence of ANA or anti-dsDNA antibodies).
4. Are on a SLE treatment regimen consisting of any of the following medications (alone or in combination):
5. A female subject is eligible to enter the study if she is:
NOTE: MMF and other forms of mycophenolate affect the metabolism of oral contraceptives and may reduce their effectiveness. As such, women receiving mycophenolate who are using oral contraceptives for birth control should employ an additional method (eg, barrier method).
6. Have the ability to understand the requirements of the study, provide written informed consent, including consent for the use and disclosure of research-related health information, and comply with the study data collection procedures.
*Achieve Clinical Research conducts Clinical Studies in Birmingham, AL. For more information about getting started with a Lupus Clinical Trial, please visit our website or contact us directly at (205) 380-6434