Research

Daniel Kastner, M.D., Ph.D.
Clinical Director, NIAMS Intramural Research Program
Phone: (301) 496-3374
Fax: (301) 402-0765
E-mail: kastnerd@mail.nih.gov

Clinical Programs

The Office of the Clinical Director implements innovative clinical research programs that relate to the broad field of rheumatologic, musculoskeletal and skin disorders. Through specific programs in translational research, rheumatology fellowship training,and health partnership, the Office of the Clinical Director plays an important role in establishing innovative therapeutic paradigms, medical education in the field of rheumatology, and by reaching out to the community to reduce health care disparities and improve the understanding of rheumatic and related diseases.

Translational Research: The Bridge Between Basic Research and Clinical Disease
A goal of clinical investigation is to bridge information gained from laboratory research with that afforded by clinical experience. Carefully designed observational and interventional studies provide opportunities to verify basic biological understanding of disease. These studies then bring back to the laboratory new insight into the biology of the human body.

Rheumatology Fellowship Program
The NIAMS/NIH Rheumatology Fellowship Training Program is dedicated to the clinical and research training of physicians wishing to pursue careers in biomedical or translational research related to the rheumatic diseases. The fellowship program is two years in duration, with extensions available for individuals interested in advanced research training. The program is accredited by the ACGME and graduates are eligible to sit for the certifying examination in the subspecialty of rheumatology.

NIAMS Community Health Center/Cardozo Clinic
The NIAMS Community Health Center/Cardozo Clinic is a health information and medical center providing health care services to people affected by arthritis, lupus, and other rheumatic diseases. The health center offers patient care with access to a specialist, health information and education programs, and refer to clinical investigations for the prevention and treatment of rheumatic diseases. The health center is located in upper northwest Washington, D.C.

Current Protocols

The Clinical Program is engaged in several observational studies to understand the natural history of several rheumatic diseases and to test therapeutic interventions. For more information or to access a Protocol, please search the database of clinical studies being conducted at the NIH Clinical Center.

Systemic Lupus Erythematosus

04-C-0095: A Pilot Study of Intensified Lymphodepletion Followed by Autologous Hematopoietic Stem Cell Transplantation in Patients with Severe Systemic Lupus Erythematosus. The long-term goal of this research is to develop a basis for future transplant protocols that would incorporate new cellular or other immunotherapeutic interventions to further improve results of transplants with the ultimate goal to cure SLE.

02-AR-0131: Collection of Blood Components Using Apheresis From Patients with Rheumatic Diseases and Healthy Volunteers. Blood components will be collected using apheresis from normal volunteers and patients with rheumatic diseases. Mononuclear cells and plasma will be used by various investigators for research studies.

94-AR-0066: Studies of the Pathogenesis and Natural History of Systemic Lupus Erythematosus (SLE). This study admits patients with systemic lupus erythematosus. The goal is to identify clinical subsets of patient that might aid in understanding progress and determining appropriate therapies.

Arthritis

03-AR-0133 Clinically Important Changes in Rheumatoid Arthritis. This study will explore how patients with Rheumatoid Arthritis evaluate, or rate, symptom improvements. This study will examine how much of an improvement in pain, stiffness, function, and other symptoms is needed before patients consider the change an important improvement.

00-AR-0222: Studies of the Pathogenesis and Natural History of Arthritis and Related Conditions. This study admits patients with rheumatoid arthritis or juvenile rheumatoid arthritis. The goal is to understand the progression of the disease and the associated medical conditions.

00-AR-0220: Randomized Double Blind Active Treatment Controlled Trial of the Anti-TNF-alpha Antibody Infliximab in Patients with Rheumatoid Arthritis. Active Follow-up, Protocol NOT Recruiting New Patients.

98-AR-0124: Genetics of Rheumatoid Arthritis: The North American Rheumatoid Arthritis Consortium. Active Follow-up, Protocol NOT Recruiting New Patients.

Periodic Fever Syndromes

05-AR-0014: A Pilot Open-Label Study of IL 1 Trap in Adult Subjects with Autoinflammatory Disease: A Therapeutic Approach to Study Pathogenesis. This study will examine the safety and effectiveness of interleukin-1 (IL-1) Trap for treating patients with autoinflammatory diseases-conditions with intense episodes of inflammation, such as fever, rash, or joint swelling. IL-1 Trap blocks a substance called IL-1 that may be important in causing the inflammation in these diseases.

94-AR-0105: Genetics and Pathophysiology of Familial Mediterranean Fever and Related Disorders. This study admits patients with familial mediterranean fever and other episodic inflammatory syndromes. The goal is to identify subsets of patients to define distinct genetic diseases and their clinical manifestations.

Neonatal Onset Multisystem Inflammatory Disease (NOMID)

05-AR-0014: A Pilot Open-Label Study of IL 1 Trap in Adult Subjects with Autoinflammatory Disease: A Therapeutic Approach to Study Pathogenesis. This study will examine the safety and effectiveness of interleukin-1 (IL-1) Trap for treating patients with autoinflammatory diseases-conditions with intense episodes of inflammation, such as fever, rash, or joint swelling. IL-1 Trap blocks a substance called IL-1 that may be important in causing the inflammation in these diseases.

03-AR-0298: A Pilot Study with the IL-1 Receptor Antagonist Anakinra/Kineret in Patients with Neonatal Onset Multisystem Inflammatory Disease (NOMID/CINCA Syndrome). This is a multi-center pilot study using the IL-1 receptor antagonist anakinra to treat children with Neonatal Onset Multisystem Inflammatory Disease (NOMID), also known as chronic infantile neurological, cutaneous and arthopathy (CINCA) syndrome.

03-AR-0173: Studies of the Pathogenesis and Natural History of Neonatal Onset Multisystem Inflammatory Disease (NOMID). This study will examine and test patients with neonatal onset multi-system inflammatory disease (NOMID) to learn more about the cause and course of the disease. It will study the disease signs and symptoms and the possible role of a gene called CIAS1, and it will develop a database to gather information on patients with NOMID in the United States and around the world. It will also serve as a screening protocol to offer eligible patients participation in a treatment protocol, if an appropriate one is available.

Myositis

02-AR-0156: A Randomized, Double-Blind, Placebo-Controlled Trial of Infliximab In Patients With Dermatomyositis and Polymyositis. This study will examine whether infliximab (Remicade® (Registered Trademark)) is safe and effective for the treatment of dermatomyositis and polymositis. Infliximab blocks the effect of a protein called tumor necrosis factor (TNF), which is associated with harmful inflammation in many diseases.

91-AR-0196: Studies of the Natural History and Pathogenesis of Polymyositis, Dermatomyositis and Related Diseases. This study admits patient with polymyositis, dermatomyositis and other muscle diseases. The goal is to understand the progression of these diseases.

Ankylosing Spondylitis

04-AR-0205: Progression of Spinal Fusion in Ankylosing Spondylitis. This pilot study seeks to determine if a CT (computerized tomography) scan can measure changes in fusion of the spine better than regular x-rays.

03-AR-0131: Genetic Determinants of Ankylosing Spondylitis Severity - Longitudinal Study. This study will explore how genes may influence the severity of ankylosing spondylitis, a form of arthritis that affects the spine. Participants for this study should have had symptoms of ankylosing spondylitis for 20 years or more.

03-AR-0130: Genetic Determinants of Ankylosing Spondylitis Severity - Cross Sectional Study. This study will explore how genes-units of heredity-may influence the severity of ankylosing spondylitis. Participants for this study should have had symptoms of ankylosing spondylitis for less than 20 years.

Immunodeficiency

99-AR-0004: Molecular Basis of Primary Immunodeficiencies. This study is to identify the genetic basis for immunodeficiencies in patients for whom the genetic basis is unknown. The goal is to identify genes important in the immune system regulation which are mutated or defective in patient with primary immunodeficiencies.

Health Disparities

01-AR-0227: Natural History of Rheumatoid Disease in Minority Communities. This study is designed to address the differences in clinical manifestations and severity of rheumatologic disease in African-Americans and Hispanic individuals.