Treatment Efficacy and Toxicity in Rheumatoid Arthritis Database and Repository

2014-08-27 03:15:50 | BioPortfolio


To stimulate collaborative efforts of federal funding agencies, voluntary health agencies, professional organizations and industry partners to enable creation of a large, sustainable database and repository to better understand the molecular basis of treatment and rapidly accelerate translational research in RA.


Rheumatoid arthritis (RA) is the most common inflammatory arthritis, affecting ~1% of the US population. Severity of RA varies from mild synovitis to joint destruction with associated disability and increased mortality. Methotrexate (MTX) is the major drug used to treat RA and the anchor drug for clinical trials of investigational new drugs (INDs) in RA. Eight biologic agents are currently FDA-approved for RA. No drug is effective in every patient, and there is great variability in toxicity and price.

The use of concomitant MTX and biologic agents has dramatically improved the outcomes of RA treatment in the US. This proposal is based on the premise the next major advance needed in the treatment of RA is not additional drugs, but rather a dramatic improvement in the efficiency and cost-effectiveness of the use of drugs for individual patients with RA. One of the hopes for modern medicine is the realization of "personalized" medicine, which allows accurate, quick prediction of which drug will be the most efficacious, least toxic, and least expensive for an individual patient.

One of the major obstacles to identifying clinically useful markers of treatment response in RA is the lack of cohorts with prospectively collected treatment response data coupled with biological samples. Because of the importance of this issue and the paucity of funding for such efforts, multiple efforts to establish single institution (using institutional funds) or multisite cohorts and repositories (typically dependent on private practitioners and pharmaceutical company support) are planned. To date, there has been no attempt to harmonize the efforts of the US academic RA research community to create a public resource.

Recognizing that building de novo cohorts within a short time frame is not feasible, our current proposal will fill a critical need: establishing an infrastructure of academic investigators to lay the foundation for future collaborative large-scale registries; and uniting the efforts of many organizations with the common goal of improving care of RA patients. This project will facilitate future research that will result in significant, publicly visible improvements in health care. Identifying predictors of treatment response in RA will lead to rapid, early institution of optimal drugs rather than a "hit or miss" sequential approach; reduce adverse events; improve patient compliance; and lead to substantial reduction in the cost of health care. By unifying the efforts of academic researchers, we can create unique resources, such as a bank of cryopreserved blood cells to allow sophisticated immunologic research to dissect molecular signals of successful treatment of RA.

In order to determine the feasibility of this infrastructure for prospectively collecting data and samples we will enroll a small number of participants (10/site/year for each of 2 years, for a total of 200 participants).

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Rheumatoid Arthritis


University of Alabama at Birmingham
United States




University of Alabama at Birmingham

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:15:50-0400

Clinical Trials [1401 Associated Clinical Trials listed on BioPortfolio]

Effect of Smoking on Pain and Atherosclerosis in Patients With Rheumatoid Arthritis

Primary aim: examine a possible connection between cigarette smoking, disease activity and perceived pain in patients with rheumatoid arthritis. Secondary aim: Evaluate cardiovascular ris...

Safety Study of Abatacept to Treat Rheumatoid Arthritis

The purpose of this study is to compare the incidence rates of infection, malignancy and death among patients with rheumatoid arthritis who are treated with abatacept and those who are tre...

Activity Limitations in Rheumatoid Arthritis

Objective: To evaluate what factors contribute to activity limitations in subjects with rheumatoid arthritis considering the International Classification of Functioning, Disability and Hea...

Rosuvastatin in Rheumatoid Arthritis (RORA)

Patients with rheumatoid arthritis are at increased risk of having cardiovascular deaths. Our study is aimed at looking at the effects of proven cholesterol lowering treatment drug called ...

A Study of a Novel Investigational Drug in Rheumatoid Arthritis Patients

This study will look at whether this new drug is effective in the treatment of rheumatoid arthritis, and at whether it is safe and well-tolerated by patients with the disease.

PubMed Articles [1054 Associated PubMed Articles listed on BioPortfolio]

Methotrexate did not improve endothelial function in rheumatoid arthritis: a study in rats with adjuvant-induced arthritis.

Rheumatoid arthritis is associated with an increased cardiovascular risk, secondary to endothelial dysfunction. There is accumulating evidence that methotrexate reduces cardiovascular risk in rheumato...

Rheumatoid arthritis in remission : Decreased myostatin and increased serum levels of periostin.

Chronic inflammation of rheumatoid arthritis (RA) is associated with disturbances in muscle and bone metabolism.

Effects of TNF-α in rheumatoid arthritis via attenuating α1 (I) collagen promoter.

To explore the role of TNF-α in the peripheral blood of patients with rheumatoid arthritis (RA) and its underlying mechanism.

Recombinant interferon alpha 2b in rheumatoid arthritis: good antigen for rheumatoid arthritis antibodies.

Interferon alpha-induced arthritis and activation of the type 1 interferon pathway during rheumatoid arthritis (RA) has been well documented but the underlying mechanism remains unclear. This study ad...

A Qualitative Exploration of Triangulated Shared Decision Making in Rheumatoid Arthritis.

Treat-to-target implementation in rheumatoid arthritis (RA) requires a shared decision making (SDM) process. However, ability to pay is a major determinant of patient choice, but how this factor affec...

Medical and Biotech [MESH] Definitions

Arthritis in children, with onset before 16 years of age. The terms juvenile rheumatoid arthritis (JRA) and juvenile idiopathic arthritis (JIA) refer to classification systems for chronic arthritis in children. Only one subtype of juvenile arthritis (polyarticular-onset, rheumatoid factor-positive) clinically resembles adult rheumatoid arthritis and is considered its childhood equivalent.

Rheumatoid arthritis of children occurring in three major subtypes defined by the symptoms present during the first six months following onset: systemic-onset (Still's Disease, Juvenile-Onset), polyarticular-onset, and pauciarticular-onset. Adult-onset cases of Still's disease (STILL'S DISEASE, ADULT-ONSET) are also known. Only one subtype of juvenile rheumatoid arthritis (polyarticular-onset, rheumatoid factor-positive) clinically resembles adult rheumatoid arthritis and is considered its childhood equivalent.

A variable mixture of the mono- and disodium salts of gold thiomalic acid used mainly for its anti-inflammatory action in the treatment of rheumatoid arthritis. It is most effective in active progressive rheumatoid arthritis and of little or no value in the presence of extensive deformities or in the treatment of other forms of arthritis.

Systemic-onset rheumatoid arthritis in adults. It differs from classical rheumatoid arthritis in that it is more often marked by acute febrile onset, and generalized lymphadenopathy and hepatosplenomegaly are more prominent.

Antibodies found in adult RHEUMATOID ARTHRITIS patients that are directed against GAMMA-CHAIN IMMUNOGLOBULINS.

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