Department of Medicine

University of Pittsburgh

Research

Research Expenditures in Rheumatology and Clinical Immunology

Research Expenditures in Rheumatology and Clinical Immunology

Areas of Research

 

Myositis - Polymyositis and Dermatomyositis (view clinical trials)

Polymyositis (PM) and dermatomyositis (DM) represent autoimmune diseases in which muscle is inappropriately targeted for immune-mediated destruction. Both of these inflammatory myopathies can produce systemic complications that include vasculopathy (Raynaud's phenomenon), arthritis, dysphagia, cardiac dysfunction, and interstitial lung disease. Clinically, the presence of a pathognomonic skin rash (Gottron's rash) distinguishes dermatomyositis from polymyositis. These two entities also differ histologically, reflecting potential differences in their immunopathogenesis. While DM is characterized by pervasive B cells, CD4+ T cells, and membrane attack complex formation (terminal complement components C5-C9), the immunohistologic hallmarks of deposition. Thus, DM appears to result from immune complex-triggered vascular/perivascular inflammation, whereas, PM stems from T cell-mediated cytolysis/dysfunction of muscle cells.

Dr. Oddis' primary research interest includes the clinical, epidemiologic and serologic aspects of idiopathic inflammatory myopathy. He has written extensively on the diagnosis and management of patients with myositis including use of novel immunosuppressive agents such as tacrolimus. Dr. Oddis is the principal investigator on a recently awarded 5-year NIAMS contract (10/04-10/09) to study the efficacy of a novel biologic agent, rituximab, in adult and pediatric myositis. He has been a co-investigator on two NIH-funded osteoarthritis trials; one (DOXY study) tested the efficacy of doxycycline in preventing the progression of knee osteoarthritis in middle-aged women and the second (GAIT) is assessing the effect of glucosamine and chondroitin sulfate on the pain of osteoarthritis and its radiographic progression. He serves as the Director of the Fellowship Training Program and the Medical Director for outpatient services.

View Dr. Oddis' recent publications

 

Osteoarthritis (view clinical trials)

OA is a non-inflammatory disease that breaks down joint cartilage, causing pain and stiffness. OA usually occurs in weight-bearing joints (such as the hips, knees, spine, back and/or neck), but it also may occur in finger joints, toe joints or the spine. OA is known by many other names, such as degenerative joint disease, arthrosis, osteoarthrosis, and hypertrophic arthritis

Dr. Kwoh's major area of research involves outcome assessment and health services utilization related to osteoarthritis. His work has focused on determinants of ethnic variations in elective total joint replacement and on risk factors for incidence and progression of osteoarthritis.

View Dr. Kwoh's recent publications

 

Rheumatoid Arthritis (view clinical trials)

Rheumatoid arthritis (RA) is a form of arthritis that has inflammation in the lining of the joints (synovium) and at times in internal organs. This inflammation separates RA from the most common form of arthritis, osteoarthritis. RA can affect any joint with synovium, especially in the hands, feet, knees, shoulders, and hips. The course of RA is variable and unpredictable with damage occurring to joint cartilage, tendons, ligaments, and bone.

Dr. Morelands' research focuses on therapies for various autoimmune diseases (rheumatoid arthritis, vasculitis, systemic lupus erythematosus, spondyloarthropathies) and osteoarthritis. He and collaborators have established multicenter collaborative efforts in several areas of research. Examples of active research include evaluating genetic and environmental factors in pathogenesis of African Americans with rheumatoid arthritis, evaluating efficacy (and molecular mechanisms) of various disease modifying agents used to treat rheumatoid arthritis, and new approaches aimed at developing disease remission for patients with rheumatoid arthritis.

Dr. Levesques' research focuses on the role of B cells in the development of rheumatoid arthritis and related autoimmune disorders. Medications that deplete B cells are used clinically to treat patients with rheumatoid arthritis, systemic lupus erythematosus and other disorders associated with autoantibodies. However, little is known about how B cell depletion results in the clinical improvements seen in patients with these disorders. Dr. Levesque's research group is studying the relationship between rheumatoid arthritis disease activity and memory B cells and plasmablasts, which produce anti-CCP autoantibodies. For these studies, Dr. Levesque's group has developed flow cytometry techniques for the identification and isolation of B cells that bind CCP and PCR-based techniques for the isolation of monoclonal antibodies from these B cells. These same techniques are applicable to studies of other disorders that involve B cells.

 

Scleroderma (view clinical trials)

Scleroderma is characterized by hardening and thickening (sclera) of the skin (derma). There are two forms of the disease. Systemic scleroderma (systemic sclerosis) is capable of causing serious, potentially fatal internal organ involvement, while localized scleroderma affects the skin only.

Both systemic and localized scleroderma are disorders in which the patient's immune system is activated and leads to tissue damage, with the end result being excessive deposition of collagen (fibrosis). Distinct subsets of patients have now been identified which assist in identifying future risks and help to direct treatment approaches.

The UPMC Scleroderma Clinic has specialized in the diagnosis and treatment of scleroderma for over 50 years. We have evaluated over 5000 scleroderma patients. Our physicians are recognized as leaders in the field and have authored over 300 publications on scleroderma in the medical literature. We offer a comprehensive approach to diagnosis and treatment the latter tailored to the needs of the individual patient.

Diagnosis of Systemic Sclerosis

Although this disease can affect many organ systems, 99% of patients have each of the following: 1) Raynaud phenomenon (color changes at the tips of the fingers on cold exposure or with emotional stress), 2) sclerodactyly (skin thickening of the fingers), or 3) a positive antinuclear antibody (ANA) test. A patient with none of these 3 findings is highly unlikely to have systemic sclerosis. A skin biopsy is not necessary to confirm the diagnosis. Rheumatologists establish the diagnosis of scleroderma on the basis of patient history, physical examination, ANA and other laboratory testing.

Other Common Symptoms and Signs

  • joint pain and stiffness, particularly affecting the small joints of the hands with prominent morning "stiffness" lasting over 1 hour; swollen fingers; inability to straighten the fingers (contractures)
  • new onset heartburn or indigestion; bread or meat getting "stuck" in the mid-chest (behind the breastbone) during swallowing; abdominal bloating or distention within 1 hour after eating; frequent watery diarrhea accompanied by weight loss
  • shortness of breath on exertion
  • sudden onset of severe high blood pressure with headache or blurry vision

Laboratory Tests

  • blood tests for ANA and a number of scleroderma-associated antibodies (some commercially available; others done by our Scleroderma Research Laboratory)
  • esophagram (x-ray study in which the function of the esophagus is examined while the patient swallows barium)
  • pulmonary function (breathing) tests
  • high resolution CT scan of the lungs
  • routine electrocardiogram (EKG) and echocardiogram
  • routine blood tests (CBC), tests of kidney function , urinalysis

Treatment

Treatment depends on the patient's disease subtype. When there is internal organ involvement present or an increased risk of such involvement, immune system suppressing drugs are used. Raynaud phenomenon is treated with blood vessel dilators, joint pain with anti-inflammatory drugs and heartburn with stomach acid-blocking medications. A vigorous exercise program is often recommended to prevent loss of joint motion and to strengthen the muscles surrounding affected joints.

view recent publications

 

Systemic Lupus Erythematosus (view clinical trials)

Lupus is a chronic inflammatory disease that can affect various parts of the body, especially the skin, joints, blood, and kidneys. The body's immune system normally makes proteins called antibodies to protect the body against viruses, bacteria, and other foreign materials. These foreign materials are called antigens. In an autoimmune disorder such as lupus, the immune system loses its ability to tell the difference between foreign substances (antigens) and its own cells and tissues. The immune system then makes antibodies directed against "self." These antibodies, called "auto-antibodies," react with the "self" antigens to form immune complexes. The immune complexes build up in the tissues and can cause inflammation, injury to tissues, and pain.

Dr. Liang joined the Lupus Center of Excellence at UPMC in September 2008 after completing her Rheumatology fellowship at the Mayo Clinic. Her primary research interests are in cardiovascular disease and atherosclerosis in rheumatoid arthritis and lupus, vasculitis, and the role of immunosenescence in rheumatic diseases.

 

Vasculitis

The word vasculitis means "inflammation of blood vessels." There are many different types of blood vessels in the body. Any particular vessel is part of a large vascular "tree" that includes large and medium sized arteries and smaller and smallest arterial branches (arterioles). These branches eventually reach all the tissues of the body, delivering oxygen and nutrients to a network of tiny vessels, called capillaries, that also remove wastes. The capillaries drain into the venous system. The smallest veins are venules; these connect like the tributaries of a river to form larger and larger veins.

Vasculitis can affect any of these different types of blood vessels. Inflammation can affect the lining of the vessels (endothelium) or the wall of an artery or vein. The damaged vessel does not function normally, and tissues that the vessel normally serves may then be affected. The effects of vasculitis that result from damage to the blood vessel include decreased function due to decreased blood flow (ischemia), death of some or all of an organ due to absent blood flow (infarction), or bleeding into the skin or other part of the body due to rupture of the blood vessel wall. Because vasculitis is a process that involves inflammation, it is usually accompanied by other features such as fever, or symptoms of involuntary weight loss and fatigue.

 

Connective Tissue Disease

Banking of Biological Samples and Collection of Clinical Data for Connective Tissue Disease Research
Investigator: Thomas A. Medsger, Jr., MD
Co-Investigators: Division of Rheumatology Faculty Members

Lay Summary
Connective tissue diseases are chronic diseases that involve damage of connective tissues such as the lining of the joints, blood vessel walls, muscle, skin, and certain internal organs. These diseases are also known as autoimmune diseases because the body's immune system reacts against its own tissues. Treatment has improved over the past 20 years, but there is still much that is not understood about the complications, causes, and treatments of these diseases.

The purpose of this project is to develop and maintain a Rheumatology Biological Specimen Bank of blood and tissue samples and a parallel Research Databank of computerized medical information. This is to support research of the CTDs and the factors that contribute to their onset and course of these diseases.

Inclusion Criteria:

  • All ages
  • Male or female
  • Visit to the Arthritis and Autoimmunity Center at UPMC
  • Diagnosis of scleroderma, Raynaud disease, myositis, or autoimmune lung fibrosis and related disorders

Contact person: Mary Lucas (412) 383-8699
Status: Actively Recruiting

 

Clinical Trials

MYOSITIS (Polymyositis and Dermatomyositis)

Novartis Protocol No. CBAF312A2202. A multi-centre, double-blind, placebo controlled, proof of concept study to evaluate the efficacy and tolerability of BAF312 in patients with polymyositis and dermatomyositis.

Lay Summary: This study is designed to determine the efficacy, safety and tolerability of BAF312 in patients with polymyositis and dermatomyositis. Participants will complete 13 study visits over a 28 week period. All participants will receive active drug during the study. Subjects will be asked to keep a diary throughout the study and have the following procedures competed at various visits: ECG, Holter Monitor, Mobile Cardiac Telemetry, Pulmonary Function Test, Chest X-ray, Blood draw, Manual Muscle Test, Ophthalmologist Examination, Dermatologist Examination, and Muscle Biopsy (optional). If you have any questions regarding this research trial, please contact the study coordinator.

Contact: Diane Koontz (412) 383-8674
Status: Actively Recruiting

Physician Summary: Novartis Pharmaceutical is sponsoring a multi-center trial in adult polymyositis (PM) and dermatomyositis (DM) patients. The purpose of the study is to determine the efficacy, safety and tolerability of BAF312, in patients not responding to traditional immunosuppressive and/or corticosteroid therapy. As PM/DM is suggested to be mediated by autoreactive lymphocytes, prevention of lymphocyte trafficking by BAF312 may inhibit pathogenic T cells and B cells from entering the muscle. Treatment with BAF312 has proven to be well-tolerated resulting in a rapid decline of the absolute lymphocyte count in Phase I trials. BAF312 has been administered to over 200 healthy male and female volunteers and was well tolerated, demonstrating a favorable safety profile. Subjects must be between 18-75 years of age with "definite" or "probable" PM or DM based on the criteria of Bohan and Peter at least three months before study entry. Participants will complete 13 study visits during this 28-week clinical trial. All patients will receive active drug but in Period 1, patients will first be randomly assigned to one of 2 treatment arms (BAF312 or placebo) in a ratio of 1:1 with approximately 20 patients/arm. During Period 2 all patients will receive BAF312. Participants will receive financial compensation for participation in the study. If you have questions regarding this trial, please contact the study coordinator.

Contact: Diane Koontz (412) 383-8674
Status: Actively Recruiting


SYSTEMIC LUPUS ERYTHEMATOSUS

ILLUMINATE Research Study

Lay Summary
The ILLUMINATE research studies will evaluate how safe and effective an investigational study medication will be as a possible lupus treatment, when compared with placebo (inactive substance).

We invite you to join us in evaluating an investigational new medication for lupus. Qualified individuals are those who have been diagnosed with systemic lupus erythematosus (SLE) and are 18 years of age or older. Other criteria must be met in order to participate and will be determined at the study site.

Participation in the ILLUMINATE research studies will last approximately one year. During this time, participants will be asked to attend monthly visits at the study site. Participants will receive either the study medication or placebo (inactive substance) to be administered as an injection under the skin every 2 weeks. You may be able to continue taking stable doses of some standard lupus medications that you may already be using to manage your lupus symptoms. At the end of the research study, you will have the opportunity to possibly participate in a 4-year extension study, the ILLUMINATE-X Study.

Qualified participants will receive the study medication and study-related physical examinations at no charge. Compensation for time and study-related travel may also be available.
Contact Number: (412) 586-3546
Status: Actively Recruiting

Physician Summary
The ILLUMINATE study is a Phase III, Multicenter, Randomized, Double-blinded, Placebo-controlled clinical research study involving the use of an investigational study medication (LY2127399) that is a human monoclonal antibody that neutralizes both the soluble and membrane-bound forms of BAFF. Through its therapeutic modulation of B lymphocytes, it may have a potentially favorable risk-benefit profile for the treatment of SLE patients. This study will include subjects with a wide range of SLE organ involvement who may be receiving a number of previous therapies, or are concurrently receiving one or more SOC therapies.

This clinical research study is composed of a screening period, double-blind, placebo-controlled treatment period, and a follow-up period. During the treatment period participants will be randomized to receive the investigational medication or placebo as a subcutaneous injection for up to 52 weeks. Upon completing the 52-week treatment period, subjects will be offered the opportunity to enter an extension study - ILLUNINATE- X and will receive study medication during the extension phase of the study.
Contact Number: (412) 586-3546 Status: Actively Recruiting

Basic Research Program

Gaffen Lab

T cell-derived cytokines are critical for mediating host defense against infectious disease, but they also mediate disease pathology in autoimmunity. In the last few years a new type of CD4+ T cell was discovered that plays a key role in autoimmunity. Distinct from the classic Th1 and Th2 populations, these cells are termed "Th17" based on their production of the signature effector cytokine IL-17. A number of innate immune cells also produce IL-17, such as gamma delta -T cells, and this cytokine appears to link innate and adaptive immunity in a variety of ways. IL-17 and its receptor are unique in structure and sequence from other known cytokines, and the Gaffen lab was among the first to study signaling mechanisms mediated by this novel family of cytokines. Dr. Gaffen's group takes a variety of biochemical, molecular and in vivo approaches to defining IL-17-mediated Signaling. In addition, members of the Gaffen lab demonstrated that IL-17 is critical for immunity to mucosal fungal infection with the commensal yeast Candida albicans. Research in the Gaffen lab is now heavily focused on defining the biological function of IL-17 and its receptor in the context of the oral mucosa. Lastly, treatment of autoimmune diseases has been revolutionized in the last decade or so by "biologic" drugs that neutralize cytokines, such as etanercept (a TNF receptor antagonist) and tocilizumab (an IL-6 receptor antagonist). Many of these drugs target the Th17/IL-17 pathway, and antibodies to IL-17 are now in clinical trials. Dr. Gaffen's group is attempting to understand the physiological impact of cytokine blockade in humans, particularly with respect to the IL-17 signaling pathway and its effects on susceptibility to mucosal infections such as oral candidiasis.

Sarah Gaffen, PhD
Associate Professor
sig65@pitt.edu
S703 BST South
3500 Terrace Street
Pittsburgh, PA 15261

Phone: 412-383-8903
Fax: 412-383-8864

Clinical Research Program

Patient Registries

The Scleroderma Center is currently participating in many multi-center trials of medications which address particular scleroderma-related problems. If you live in our geographic area, Pittsburgh is a logical site, but if you live in another part of the country, you should contact the participating site closest to you for additional details.

Click here for more information about these studies.


Abatacept and Cyclophosphamide Combination: Efficacy and Safety Study (ACCESS) for Lupus Nephritis

Lay Summary: The purpose of this study is to find out if abatacept used with cyclophosphamide, corticosteroids and azathioprine is safe and works better in patients with lupus nephritis than treatment of cyclophosphamide, corticosteroids, and azathioprine therapy alone. In other words, the researchers would like to see what effects (good or bad) abatacept has on you and other patients with systemic lupus erythematosus (SLE) and nephritis. The study drug abatacept has been approved by the FDA for the treatment of moderate to severe rheumatoid arthritis, however it is an experimental medication for lupus nephritis. Participation in the study will last for two years.

Contact Number: (412) 586-3546
Status: Actively Recruiting

Physician Summary: This is a randomized, double-blind, controlled phase II multi-center trial in individuals with biopsy proven lupus nephritis. All subjects enrolled in the ACCESS trial will receive pulse cyclophosphamide therapy in addition to either abatacept or abatacept placebo. The trial employs the Euro-lupus regimen for cyclophosphamide, which uses lower doses of cyclophosphamide compared to the conventional NIH-regimen, yet appears to maintain similar efficacy. Subjects will receive 6 intravenous infusions of cyclophosphamide every other week, then oral azathioprine daily for at least 12 subsequent weeks. Abatacept or a placebo will be administered every 2 weeks at first, then every 4 weeks for at least the first 6 months. Subjects are assessed at 24 weeks, with subsequent therapy depending on the nature of the response observed. Treatment with abatacept or placebo and azathioprine may continue for the remainder of the year. All subjects will receive daily oral prednisone for the duration of the study, with tapering of the dose as the study progresses.

Contact Number: (412) 586-3546
Status: Actively Recruiting


Effect of Vitamin D3 on the IFN Alpha Signature in Patients With Systemic Lupus Erythematosus

Lay Summary: Vitamin D plays a role in bone health as well as in immune health. Many people are deficient in vitamin D. In patients with SLE, vitamin D deficiency may play a role in the disease and contribute to the presence of an interferon (IFN) signature in the blood. The purpose of this study is to determine if vitamin D replacement can lower or eliminate the IFN signature. Patients with SLE may qualify if they have low vitamin D levels (< 20 ng/ml), stable disease activity, and the IFN signature present in their blood - all of which will be tested at a screening visit. Patients who qualify are randomized to placebo, 2000 IU / day, or 4000 IU / day of vitamin D to take by mouth for 12 weeks. There are a total of 4 study-related visits.

Contact Number: (412) 586-3546
Status: Actively Recruiting

Physician Summary: This is a double-blind, multi-center, placebo controlled, Phase II study designed to assess biologic effects of 12 weeks of vitamin D3 supplementation on patients with well-controlled stable systemic lupus erythematosus who have low serum levels of 25-OH vitamin D and an IFNa signature. Subjects will be randomized to placebo, vitamin D3 2000 IU daily or vitamin D3 4000 IU daily in a 1:1:1 ratio. The primary objective of the study is to explore the impact of vitamin D3 supplementation on the expression of an IFNa signature after treatment will be compared among the treatment groups. There are two secondary objectives: 1) The impact of 25-OH vitamin D serum levels on clinical indicators of disease in SLE patients with vitamin D deficiency will be explored. Changes in lupus serology (anti-dsDNA, C3, and C4) and disease activity (BILAG, SELENA-SLEDAI) will be described in the three treatment groups and its relationship with serum 25-OH vitamin D levels after 12 weeks of treatment will be explored. 2) The safety and tolerability of vitamin D3 supplementation in vitamin D deficient SLE patients will be compared to placebo.

Contact Number: (412) 586-3546
Status: Actively Recruiting


Concurrent Pilot Studies in Giant Cell Arteritis and Takayasu’s Arteritis to Examine the Safety, Efficacy and Immunologic Effects of Abatacept in Large Vessel Vasculitis: VCRC 5523

Lay Summary: The purpose of this study is to determine the effectiveness and safety of the medication abatacept in giant cell arteritis or Takayasu’s arteritis.

In this study all people will initially receive abatacept combined with stand doses of prednisone. At month 3, if you are in remission, meaning there is no evidence of active giant cell arteritis or Takayasu’s arteritis, you will undergo a process called a randomization whereby a determination will be made as to whether you will continue to receive abatacept or switch to a placebo. The placebo is an inactive sterile salt solution.

At each study visit we will obtain a blood sample from you and you will be asked to complete a quality of life questionnaire (the SF-36 survey). You will be in the study for 12 to 24 months.

Physician Summary: This is a pilot, randomized, double-blind, Phase I-II study to determine the safety, efficacy and immunological effects of abatacept (CTLA4-lg) in patients with GCA and TAK through the conduct of concurrent randomized withdrawal trials. Abatacept is a novel agent that modulates the costimulation signal required for antigen-specific T cell activation. The actions of abatacept make this an appealing and innovative therapy to investigate in GCA and TAK, diseases for which there is a great need to identify better treatments.

All participants will initially receive abatacept at days 1,15,29 and month 2 in combination with prednisone. Prednisone will be tapered according to a standard schedule. At month 3, participants in remission will be randomized to continue abatacept or receive a placebo. Safety and efficacy will be assessed at each infusion. In the absence of relapse or toxicity, participants will continue until the common closing dat or approximately 12 to 24 months. Participants will be asked to complete an SF-36 survey and blood will be obtained at each visit.

Contact Person: Dawn McBride, BS Ed., RN, BA 412-586-3545 dlmc@pitt.edu
Status: Actively Recruiting


Longitudinal Protocol for Giant Cell Arteritis: VCRC 5502

Lay Summary: This study is being done to learn more about Giant Cell Arteritis, an unusual condition that affects the blood vessels. Giant Cell Arteritis causes swelling of the arteries around the head and neck.

You must be at least 50 years old to participate in this study. You will be seen at your regular clinic visits either once per year or four times per year at your convenience. At each clinic visit you will answer questions about your quality of life and general health and we will track that information over time. We will also ask you for a blood sample and a urine sample at your regular clinic visits.

Physician Summary: This is a longitudinal, observational study designed to discover new biomarkers of disease activity in patients with Giant cell arteritis for the purposes of diagnosis, disease activity measurement, disease damage assessment, determination of disease state, and evaluation of treatment response.

Participants will be followed at their regular clinic visits and asked to complete a Health Assessment and Quality of Life questionnaire. Participants will also be asked for blood and urine specimens that will be used to look for new proteins, genes and other chemicals that could serve as biomarkers of disease.

An assessment of medical history, physical exam, imaging studies, laboratory and other test results, medications will be obtained through the electronic medical records on each participant.

Contact Person: Dawn McBride, BS Ed., RN, BA 412-586-3545, dlmc@pitt.edu
Status: Actively Recruiting


Treatment Efficacy and Toxicity in Rheumatoid Arthritis Database: TETRAD

Lay Summary: The main purpose of this study is to evaluate the effectiveness of starting or switching biologic medications for Rheumatoid Arthritis. All visits will occur during routine physician office visits and participants will be reimbursed for time and travel.

Physician Summary: This study will be a prospective, multicenter, longitudinal observational registry of RA patients with the goal of capturing data on treatment with biologic agents, including response to therapy, toxicity, and other reasons for clinician’s changing therapy. The ultimate product, beyond the scope of this proposal, is the development of a large, publicly available database and repository of treatment response to MTX and biologic agents in RA. Subjects will receive at no cost: X-Rays of the feet and hands, laboratory tests and compensation for time and travel.

Contact: Dawn McBride (412) 586-3545

Amyloidosis Research Project

Lay Summary: The main purpose of this study is to reduce the burden on the patient and their family and to speed the time to diagnosis. We hope that this project will lead to better coordination of care for patients with amyloidosis. This research might help us in the future to look at: 1) Investigating new approaches to diagnosis of amyloidosis via gene expression profiling (DNA) and/or imaging, etc. and 2) Developing a better understanding of the prevalence of amyloidosis in patients with inflammatory arthritis (how often it occurs in those with inflammatory arthritis). Study participation involves donation of blood samples.

Physician Summary: We propose to undertake a cross-sectional study to evaluate the prevalence of amyloid among patients seen by the 33 practicing rheumatologists at UPMC and also determine serum markers of inflammation (such as C-reactive protein [CRP] and serum Amyloid A [SAA}) and correlate these measures with clinical features. A key research objective will be to determine the prevalence of amyloidosis in patients with inflammatory arthritis. Our long-term goal is to develop approaches to diagnose amyloidosis non-invasively via gene expression profiling (DNA) and/or imaging, etc. The focus on this population provides a mechanism to target and identify patients with amyloidosis, better understand the disease process and ultimately lead to targeted therapy to improve patient outcomes. We will recruit subjects with the diagnosis of Amyloidosis, suspected Amyloidosis or Monoclonal Gammopathy of Undetermined Significance (MGUS). Participation involves collecting blood samples for analysis and storage.

Rheumatoid Arthritis Comparative Effectiveness Research (RACER): Randomized Observation Study of Biologic Therapy for Rheumatoid Arthritis

Study focus: Establishment of a rheumatoid arthritis (RA) and use of the registry for cost and comparative effectiveness for biologic therapies for RA.

Name of disease: Rheumatoid Arthritis

Lay Summary: This study is designed to develop and test better systems to compare different treatments for RA in terms of effectiveness and cost. Participants will be asked to: 1) complete questionnaires about their RA, daily activities, and overall health; 2) provide blood samples (two tubes or about 4 tsp). These activities will take place during normally scheduled clinic appointments. Participants receive either parking validation or $5 cash reimbursement for parking or public transportation costs. Please contact a study coordinator for more information.

Contact: Christine Amity (412) 647-2638 or Lynne Frydrych (412) 647-3241

Physician Summary: RACER is a RA registry that will be used for cost and comparative effectiveness (CCE) studies of existing versus new and expensive biologic drug therapies for RA. Participants will be asked to complete health related questionnaires including: Routine Assessment of Patient Index Data (RAPID-3), Health and Well-being Assessment (SF-12v2), and the Work Productivity Scale (WPAI). Clinicians will perform a standardized joint count and a global VAS score to complete the Disease Activity Scale (DAS-28). In addition, biologic samples will be collected at each patient visit to determine CRP levels for the DAS28 and to determine whether certain biomarkers predict biologic therapy responsiveness; these studies may, allow for targeting of therapies most efficiently. Participants must be at least 18 years of age, fluent in English, and have a clinical diagnosis of rheumatoid arthritis to participate. Participants will receive either parking validation or $5 cash reimbursement for parking or public transportation costs.

Contact: Christine Amity (412) 647-2638 or Lynne Frydrych (412) 647-3241


PITT-MCRC for Rheumatic and Musculoskeletal Diseases

Lay Summary: This Center promotes interdisciplinary research on arthritis and musculoskeletal diseases at the University of Pittsburgh.

Physician Summary: The PITT-MCRC supports three clinical research projects that address highly important clinical problems, an Administrative Core, and a Methodology Core. The three clinical research projects involve the following disciplines: adult and pediatric rheumatology, computer science, health services research, health economics, minority health, geriatrics, and epidemiology. The two Cores of the PITT-MCRC will provide the infrastructure to: i) promote multidisciplinary clinical research in arthritis and musculoskeletal diseases, ii) provide study design and biostatistical support, iii) encourage the development of new methodologies, and iv) foster trainee and junior faculty education and development.

Contact: Stephanie Green (412) 383-4018
Status: Currently recruiting for two projects


Disparities in Joint Replacement-Pathway to Intervention (Project 2 of the PITT-MCRC)

Lay Summary: This study examines how people feel about their knee pain and treatment options, such as joint replacement for knee pain. Participants will answer survey questions about how people make decisions about arthritis treatment. To participate, you must be over 49 years of age and have frequent knee pain that has lasted for at least six months. You may be asked to have a knee x-ray.

Physician Summary: This study examines differences between African-American and white patients with knee osteoarthritis in willingness to consider knee joint replacement. Participants complete questionnaires at three time-points. A current knee radiograph may be needed for study eligibility.

Contact: Mary Jansen (412) 383-4018
Status: Closed to Enrollment


Use of Thermal and 3D Imaging to Quantify Arthritis

Lay Summary: The PARTNER Study is a research study to test a device—the Arthritis Imager that uses cameras to measure warmth and swelling in the joint of the hand and wrist. Children and adults diagnosed with rheumatoid arthritis who are having a flare of their disease may be eligible to participate. Participation involves five visits to the Arthritis Research Center at the University of Pittsburgh, completing questionnaires, undergoing a joint examination by a physician, and having pictures taken of your hands using the Arthritis Imager.

The PARTNER MRI Study is a research study to determine if persistent arthritis can be detected in rheumatoid arthritis patients who appear to be in remission. Children and adults diagnosed with rheumatoid arthritis who are in remission may be eligible to participate. Participation involves one visit to the Arthritis Research Center at the University of Pittsburgh and the MR Research Center at UPMC Presbyterian, completing questionnaires, undergoing a joint examination by a physician, and having pictures taken of your hands using the Arthritis Imager.

Physician Summary: The goal of this study is to test the hypothesis that a prototype device, using well established sensors, can improve the clinical assessment of arthritis. It will test the hypothesis that surface imaging will provide an earlier and more sensitive measure of change in active arthritis and functional status than do physician’s assessment and patient’s self-assessment. A cohort of patients with Juvenile Rheumatoid Arthritis and Rheumatoid Arthritis will be followed longitudinally before and during the course of a therapeutic intervention.

Contact: Kim Francis (412) 383-2423
Status: Currently recruiting


Pivotal OAI MRI Analyses (POMA)

Lay Summary: The investigators on this study will analyze knee magnetic resonance imaging (MRI) images from an existing database of knee MRI images. All images are from persons at risk for or currently suffering from knee arthritis.

Physician Summary: This is a contract for ancillary and complementary research to the Osteoarthritis Initiative (OAI), a national longitudinal study of knee osteoarthritis. The investigators will conduct analyses of existing MRI images from the OAI cohort over multiple study years.

Contact: Stephanie Green (412) 383-4018
Status: Database study


University of Pittsburgh Lupus Center of Excellence Patient Registry.

The purpose of this registry is to identify patients with lupus who are interested in hearing about current and future research studies in which they may be eligible to participate. As a member of the Registry, you will have the opportunity to learn about the Center's research projects on autoimmune disease and participate in those that may interest you and for which you may be eligible.