Overview
Senior Investigator
Clinical Director
Robert A. Colbert, M.D., Ph.D.
The Clinical Research Programs at NIAMS conducts patient-based investigation in the areas of rheumatic, skin, muscular and inflammatory diseases, and train the next generation of physician-scientists and clinician-investigators in these areas. As part of the NIH intramural research program, the program is uniquely positioned to perform clinical and translational studies in the NIH Clinical Center, the world’s largest hospital and outpatient facility devoted exclusively to clinical investigation. The NIAMS has a long and successful history of clinical investigation into the pathogenesis and treatment of rheumatic diseases dating back to the 1960’s, with emphases on systemic lupus, rheumatoid arthritis, inflammatory muscle disease, and hereditary periodic fever syndromes, now recognized to be part of the spectrum of autoinflammatory diseases, a term coined at NIH. These studies stem from the interests of the clinical and basic investigators in the Institute as well as through aligning with the strengths of the NIH Clinical Center, including the study of rare diseases, innovative proof-of concept (PoC) clinical trials, and longitudinal clinical studies.
The NIAMS clinical research program, in partnership with other NIH intramural research programs, currently focuses its research in the areas of autoinflammatory diseases, Systemic Lupus Erythematosus, spondylarthropathies, outcomes research, vasculitis, myositis, and selected bone and dermatological 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 insights into the normal functioning of the organ and cellular systems underlying human health and disease.
Training Programs
The NIAMS Clinical Research Program includes ACGME-certified Adult Rheumatology Fellowship Training Program, a joint Pediatric Rheumatology Fellowship Program with Childrens’ National Medical Center in Washington, DC, and Advanced basic, translational clinical research training in Rheumatology and Dermatology through the NIAMS Scholars in Translational Research Program.
NIAMS Community Health Clinic
In addition to its disease-focused clinical research programs, NIAMS operates a community health clinic which provides specialist care and screening for participation in clinical research studies for underserved patients in the local area with serious rheumatological conditions. The clinic is located on the NIH campus in Bethesda, Maryland.
Contact Us
Core Research Facilities
Labs at the NIAMS are supported by the following state-of-the-art facilities and services:
Staff
Clinical Trials
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.
Ankylosing Spondylitis and Spondylarthritis
- 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.
- 11-AR-0223: Studies on the Natural History and Pathogenesis of Spondyloarthritis (SpA). The National Institute of Arthritis and Musculoskeletal and Skin Diseases is conducting a study to learn more about the early signs and symptoms of SpA. The goal of this study is to follow the activity and progression of SpA. Patients will be screened with a comprehensive individual history and a physical examination that includes a detailed musculoskeletal exam. Participants of any age with a diagnosis of SpA may be eligible. This protocol will serve as a screening protocol for a future SpA treatment protocol.
Arthritis
- 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.
- 13-AR-0056: Stopping Anti-TNF Agents in Rheumatoid Arthritis (STARA) Trial Stopping TNF-alpha agents in Rheumatoid Arthritis . The goal of this randomized clinical trial is to test if patients with rheumatoid arthritis in remission while taking TNF-alpha inhibitors can remain in remission after withdrawal of these medications, and to determine predictors of relapse.
- 03-E-0099: Pathogenic Studies in Families of Twins or Siblings Discordant for Systemic Rheumatic Diseases. Patients diagnosed with adult or juvenile systemic lupus erythematosus within the past four years and their healthy same gender-siblings are part of a study to evaluate environmental and genetic risk factors for systemic autoimmune diseases. When available, parents also enroll. The study involves patient questionnaires, blood testing, and a physician evaluation. Further clinical evaluation may be performed as indicated when enrolling at the NIH Clinical Center. Patients may enroll from the NIH Clinical Center in Bethesda or through their local physician’s office. (Contact: Adult patient referrals: Dr. Adam Schiffenbauer at schiffenbauera2@niehs.nih.gov; Pediatric patient referrals: Dr. Lisa Rider at riderl@mail.nih.gov).
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.
Healthy Volunteers
- 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.
- 03-E-0099: Pathogenic Studies in Families of Twins or Siblings Discordant for Systemic Rheumatic Diseases
- 11-E-0072: Environmental Risk Factors for the Anti-Synthetase Syndrome, the MYORISK Study
- 13-E-0015: Environmental Risk Factors for the Development of Myositis in Military Personnel. For the three studies above, healthy volunteers matched to adult and pediatric myositis/autoimmune disease patients will be eligible for enrollment in these studies. Enrollment generally consists of a physician evaluation, patient questionnaires and blood testing.(Contact: Ms. Tasia Long at longtm@niehs.nih.gov).
- 14-AR-0200: Studies of the Natural History, Pathogenesis, and Outcome of Idiopathic Systemic Vasculitis
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.
Melorheostosis
- 15-AR-0165 Study of the Natural History, Pathogenesis and Outcome of Melorheostosis — a Rare Osteosclerotic Disease. The rare disease melorheostosis causes bones to thicken. This may lead to pain, and can affect bones, joints, and muscles. Researchers want to learn more about the disease and how it progresses. All eligible patients are invited to participate in this protocol. Patients are adults aged 18 years or older with possible melorheostosis (suspected or confirmed).
Myositis
- 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.
- 03-E-0099: Pathogenic Studies in Families of Twins or Siblings Discordant for Systemic Rheumatic Diseases. Patients diagnosed with adult or juvenile systemic lupus erythematosus within the past four years and their healthy same gender-siblings are part of a study to evaluate environmental and genetic risk factors for systemic autoimmune diseases. When available, parents also enroll. The study involves patient questionnaires, blood testing, and a physician evaluation. Further clinical evaluation may be performed as indicated when enrolling at the NIH Clinical Center. Patients may enroll from the NIH Clinical Center in Bethesda or through their local physician�s office. (Contact: Adult patient referrals: Dr. Adam Schiffenbauer at schiffenbauera2@niehs.nih.gov; Pediatric patient referrals: Dr. Lisa Rider at riderl@mail.nih.gov).
- 11-E-0072: Environmental Risk Factors for the Anti-Synthetase Syndrome, the MYORISK Study. Adults and children with dermatomyositis or polymyositis who are within one year of diagnosis are potentially eligible for this study. The goal is to evaluate environmental factors that may be important to illness onset in myositis patients with certain autoantibodies (such as Jo1) compared to those without these autoantibodies and to healthy control subjects. The study involves patient questionnaires, blood testing, a vacuum dust sample, and a physician evaluation. Further evaluation, including heart and lung studies and imaging, may be performed as clinically indicated when enrolling at the NIH Clinical Center. Patients may enroll from the NIH Clinical Center in Bethesda, through another participating center, or through their local physician’s office. (Contact: study coordinator Ms. Tasia Long at longtm@niehs.nih.gov).
- 13-E-0015: Environmental Risk Factors for the Development of Myositis in Military Personnel. Patients who developed myositis while serving on active duty in the military will be compared with military personnel who have not been diagnosed with an autoimmune disease or chronic muscle disease. The study will consist of a physician evaluation, as well as patient questionnaires and blood samples.A few patients will also contribute a muscle biopsy sample, if clinically indicated to perform this test. Patients may enroll from the NIH Clinical Center in Bethesda, through a participating military hospital or VA medical center, or through their local physician’s office. (Contact: study coordinator Mr. James Ridley: james.ridley@nih.gov).
- 94-E-0165: Studies in the Natural History & Pathogenesis of Childhood-Onset and Adult-Onset Idiopathic Inflammatory Myopathies. This study enrolls patients with adult and juvenile dermatomyositis and polymyositis primarily. Patients generally only enroll if enrolling in another NIEHS study protocol. This study provides a thorough disease evaluation, including blood testing and imaging studies. Goals of the study include examination of genetic and environmental risk factors for myositis and natural history of the disease. (Contact: Adult patient referrals: Dr. Adam Schiffenbauer at schiffenbauera2@niehs.nih.gov; Pediatric patient referrals: Dr. Lisa Rider at riderl@mail.nih.gov).
Scleroderma
- 03-E-0099: Pathogenic Studies in Families of Twins or Siblings Discordant for Systemic Rheumatic Diseases. Patients diagnosed with adult or juvenile systemic lupus erythematosus within the past four years and their healthy same gender-siblings are part of a study to evaluate environmental and genetic risk factors for systemic autoimmune diseases. When available, parents also enroll. The study involves patient questionnaires, blood testing, and a physician evaluation. Further clinical evaluation may be performed as indicated when enrolling at the NIH Clinical Center. Patients may enroll from the NIH Clinical Center in Bethesda or through their local physician�s office. (Contact: Adult patient referrals: Dr. Adam Schiffenbauer at schiffenbauera2@niehs.nih.gov; Pediatric patient referrals: Dr. Lisa Rider at riderl@mail.nih.gov).
Systemic Arthritis and Autoinflammation
- 18-AR-0081: Natural History, Genetics, and Pathophysiology of Systemic Juvenile Idiopathic Arthritis, Adult-Onset Still's Disease, and Related Conditions. This study aims to identify genetic and immunologic factors that contribute to sJIA/AOSD and related conditions and to determine their implications on inflammatory pathophysiology. By doing so, we hope to identify novel therapeutic targets for inflammatory disease.
Systemic Lupus Erythematosus
- 15-AR-0185 Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Systemic Lupus Erythematosus; a Phase 1b Clinical Trial and Associated Mechanistic Studies. This study is to determine the safety and tolerability of tofacitinib, a JAK inhibitor, in patients with SLE and mild to moderate disease activity. Tofacitinib has immunomodulatory effects via the JAK-STAT pathway. Many of the inflammatory cytokines implicated in the pathogenesis of SLE signal via the JAK-STAT pathways. We will also investigate effects of tofacitinib on vascular function in SLE subjects and identify biomarkers that may be useful as endpoints in future studies.
- 15-AR-0060 Role of PPAR-y Agonists in Immunomodulation and Vascular Prevention in SLE (PPAR-SLE). The purpose of this study is to assess the effects of a commonly used diabetes medication on lupus disease activity. Investigators are testing how this medication can improve blood vessel function and reduce inflammation in people with lupus.
- 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.
- 03-E-0099: Pathogenic Studies in Families of Twins or Siblings Discordant for Systemic Rheumatic Diseases. Patients diagnosed with adult or juvenile systemic lupus erythematosus within the past four years and their healthy same gender-siblings are part of a study to evaluate environmental and genetic risk factors for systemic autoimmune diseases. When available, parents also enroll. The study involves patient questionnaires, blood testing, and a physician evaluation. Further clinical evaluation may be performed as indicated when enrolling at the NIH Clinical Center. Patients may enroll from the NIH Clinical Center in Bethesda or through their local physician’s office. (Contact: Adult patient referrals: Dr. Adam Schiffenbauer at schiffenbauera2@niehs.nih.gov); Pediatric patient referrals: Dr. Lisa Rider at riderl@mail.nih.gov)
Vasculitis
- 14-AR-0200: Studies of the Natural History, Pathogenesis, and Outcome of Idiopathic Systemic Vasculitis. Researchers want to study people's genes and follow people over time to see how the disease affects them. People age 5 and older who have or are thought to have vasculitis, or are related to someone with it, are eligible. Healthy volunteers are also eligible.