Autoimmune disease clinical trials (ADCT)

A collaborative approach in the search for effective treatments

The Statistical and Clinical Coordinating Center for Autoimmune Disease Clinical Trials (SACCC-ADCT) provides operational support, statistical analysis, clinical data management, and regulatory guidance for two research networks: the Autoimmunity Centers of Excellence (ACE) and the Stem Cell Transplantation Consortium.

Autoimmune Centers of Excellence

The Autoimmune Centers of Excellence is funded by the National Institutes of Health (NIH) and was created to encourage collaborative basic and clinical research across scientific disciplines and medical specialties in the search for effective treatments for autoimmune diseases. Basic scientists and clinicians from nine leading research institutions support an integrated research program focused on treatment approaches that induce immune tolerance or modulate the immune system. The purview of the ACE research network encompasses more than 80 clinically distinct autoimmune diseases including systemic lupus erythematosus, type 1 diabetes, rheumatoid arthritis, Sjögren’s syndrome, multiple sclerosis, and chronic inflammatory bowel disease. Every ACE clinical study of a new therapy is designed to evaluate safety or efficacy research objectives, but it is also augmented with extensive basic science studies that explore the immune mechanisms underlying the disease process and the impact of the study therapy on these mechanisms.

The ACE network currently has several new protocols under development. In addition, 5 recently completed studies are in the analysis phase. The following 7 studies are actively enrolling:

• Use of Infliximab for the Treatment of Pemphigus Vulgaris
• Lovastatin for the Treatment of Mildly Active Rheumatoid Arthritis
• Rituximab for Treatment of Early Rheumatoid Arthritis
• Switching Anti-TNF-Alpha Agents in Rheumatoid Arthritis
• Anti-TNF-Alpha Agents in Rheumatoid Arthritis
• Vitamin D3 in Systemic Lupus Erythematosus
• Etanercept for the Treatment of Lupus Nephritis

The Stem Cell Transplantation Consortium

The Stem Cell Transplantation Consortium is researching a therapy aimed at stopping the progression of the autoimmune disease by resetting the patient’s immune system. The first component of this therapeutic regimen is suppression of the patient’s malfunctioning immune system with high-dose immunosuppressive therapy (HDIT). In the second step, the patient’s own hematopoetic stem cells, the immature blood cells from which all immune cells differentiate, are re-infused where they mature into a new immune system that in theory is tolerant to “self” and attacks only foreign entities.

Current Stem Cell Transplantation Consortium studies include:

• HALT MS: High-Dose Immunosuppression and Autologous Transplantation for Multiple Sclerosis
• SCOT: Scleroderma Cyclophosphamide or Transplantation

For more information about this research from ClinicalTrials.gov, please see below.