Juvenile Idiopathic Arthritis

BIO JIA: The biology and immunology of treatment response in polyarticular Juvenile Idiopathic Arthritis

Juvenile idiopathic arthritis (JIA) is among the most common causes of disability in children. The long-term socio-economic impact of the disease is staggering and unfortunately severely underestimated. To date, diagnostic and therapeutic tools are still not tailored specifically for the disease, but rather borrowed and adapted from adult rheumatology. With the advent of biologic therapeutic agents, the need to understand the effects that these therapies have on an immature immune system is of dramatic urgency to improve efficacy, reduce undesirable effects, and improve long-term outcomes. 

The goal of this project is to ultimately affect clinical practice by providing mechanistic evidence of clinical-immunological correlations. 

This project will contribute to a significant advancement in the area of translational rheumatology. The research is designed to gain critical insight into the mechanisms of JIA in both active and inactive disease states as well as to assess the clinical relevance and efficacy of early aggressive therapy with combination therapy of standard disease modifying anti-rheumatic drugs (DMARDs) and TNF inhibitors. 

PI: Salvatore Albani, MD, PhD

Agency:  Abbott Laboratories and the National Institutes of Health

Rheumatoid Arthritis

Mechanisms of immune tolerance and suppression in biologic therapy of rheumatoid arthritis 

There are few studies based on uniformly selected populations of patients with active rheumatoid arthritis (RA) that comprehensively address the immune mechanisms that determine a state of induction and maintenance of clinical control in patients treated with different types of biologics, in this specific case an anti-TNF.  And yet these medications are quickly accompanying, and in some cases replacing the old "gold standard" of care in RA.  

This study seeks to unravel the mechanisms behind how and why different therapies, or different combinations of therapies, work in order to improve both our understanding of the disease and to guide clinical decision-making process in order to offer the patient the best possible outcomes.

PI: Salvatore Albani, MD, PhD

Agency: To be announced.  Application under review. 

A Phase II Withdrawal Trial of DMARD Combination Therapy and Epitope-Specific Immunotherapy in Rheumatoid Arthritis

This trial expands on our previous work with epitope-specific immunotherapy.  Here, we'll pair the epitope-specific immunotherapy with disease-modifying anti-rheumatic drugs (DMARDs) used in the clinic as "standard of care" and slowly taper the standard of care therapy in order to determine the ability of the investigational drug to induce tolerance.  In other words, we will try to retrain the immune system so that it no longer has a destructive inflammatory reaction to itself.

This study has many implications for human health. The primary gains may include a better understanding of the actual mechanisms (i.e. underlying immune processes) needed to control autoimmune disease activity, such as in RA, as well as developing an innovative therapy that, as current indications demonstrate, has the potential to offer long term safe disease control to sufferers of RA.

PI: Salvatore Albani, MD, PhD

Agency:  The Immune Tolerance Network (founded by the National Institutes of Health)

Safety of biologic disease modifiers in rheumatoid arthritis in a clinical setting as a function of their responsiveness and correlation with clinical outcomes biomarkers in RA.

This study examines the safety and efficacy of standard treatments for Rheumatoid Arthritis in a clinical setting rather than a trial setting.  In other words, using the Rheumatology Health Tracking system, we are studying the effects therapies have the way that they are prescribed in the "real world".

PI: Jeffrey Lisse, MD

Agency:  Centocor, Inc.