NIAMS IRP Branch Information

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institutes of Health (NIH)

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
The NIAMS Community Health Center 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-0272: A Phase I, Open-Labeled, Dose-Ascending Clinical Trial of Immunotherapy of MRA, A Humanized Anti-IL 6 Receptor Monoclonal Antibody, in Patients with Systemic Lupus Erythematosus. This study will provide important preliminary information about the safety and possible effect of IL-6 blockade in SLE patients, an intervention that has been successful in animal models, but has not yet been studied in humans.

02-AR-0267: Role of the Antibody Against NR2 Glutamate Receptor in Cognitive Dysfunction in Patients with Systemic Lupus Erythematosus. To evaluate the association between cognitive dysfunction and serum anti-peptide antibodies in patients with systemic lupus erythematosus.

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-0208: A 24-week, Double Blind, Randomized Study to Determine the Effects of 24 Weeks of Dosing with Tripterygium Wilfordii Hook F (TwHF) or Sulfasalazine, in Subjects with Active Rheumatoid Arthritis. The purpose of this study is to investigate how tolerable, safe, and effective TwHF is for patients with rheumatoid arthritis. Investigators will compare the therapeutic effects of TwHF with Sulfasalazine, an FDA-approved drug for 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.

02-AR-0170: Suppression of the GH/IGF-1 Axis in Women with RA. This study is designed to ask whether patients with rheumatoid arthritis display endocrinologic abnormalities and whether treatment with blockade of TNF-alpha can reverse these abnormalities.

02-AR-0081: A randomized Double-Blind controlled Intra-Patient Dose Escalation Phase II Trial of Infliximab in Pediatric Patients with refractory Juvenile Rheumatoid Arthritis. This study is designed to ask whether patients with juvenile rheumatoid arthritis benefit from therapy with anti-TNF-alpha antibody and methotrexate.

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. This study is to evaluate the efficacy of MRI to detect differences in the development of new erosions in patients on methotrexate or methotrexate and antibody to TNF-alpha.

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

95-AR-0082: Studies of the Pathogenesis and Natural History of Psoriatic Arthritis. This study admits patients with psoriatic arthritis and other inflammatory arthritides. The goal is to understand disease progression and associated medical conditions.

Periodic Fever Syndromes

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)

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.