Rituximab Study
“Rituximab in the Treatment of Myositis (RIM)” is an NIH, NIAMS sponsored clinical trial being conducted at over 20 locations in the United States in addition to several Canadian and European sites.  This study will be directed and coordinated by Chester V. Oddis, MD, Professor of Medicine, University of Pittsburgh Division of Rheumatology and Ann M. Reed, MD, Professor of Pediatrics and Medicine, Chair Pediatric Rheumatology, Mayo Foundation and School of Medicine at the Mayo Clinic.  

The goal of this study is to examine the effectiveness of rituximab, a biological agent that is being studied in adult and pediatric autoimmune diseases such as rheumatoid arthritis and systemic lupus erythematosis. The result of the study will help determine the drug’s potential benefit in the management of individuals diagnosed with myositis.  Adults with dermatomyositis or polymyositis, and children five years of age and older with juvenile dermatomyositis for at least six months may be eligible to participate. 

Eligible participants will be asked to participate for up to 45 weeks for a total of 14 study visits. The study doctor will be measuring muscle strength and evaluating the symptoms of the disease. Other study tests include an electrocardiogram (ECG), physical examination, and blood testing for muscle enzymes, general chemistry and immunological tests. Study subjects may be asked to voluntarily consent to participate in a sub-study in which a muscle biopsy will be performed from a weakened muscle at study entry and again at four months. All study participants will receive the investigational study drug while participating in the study.

NIH Twin-Sibs Study
The EAG is currently enrolling families -- in which an adult or child meets criteria for Rheumatoid Arthritis/Juvenile Rheumatoid Arthritis, Systemic Lupus Erythematosus, Systemic Sclerosis or Myositis -- and in which a twin or sibling of the same gender, who is within 47 months of age, does not have any one of these 4 illnesses or another autoimmune disease. Subjects may enroll at the NIH Clinical Center in Bethesda, Maryland or in their local doctors' offices. Patients remain under the care of their personal physicians while participating in the study. There is no charge for study-related evaluations and medical tests at the NIH. For information about the NIH Twin-Sibs study please call: 800/411-1222. Click here for more information

Calcinosis Study
Calcinosis specimens from patients with myositis which have been surgically removed or biopsied are needed for a study (paraffin or frozen tissue blocks, H&E slides). The goal is to better understand the composition of these lesions in order to develop a better understanding of the causes of calcinosis and improved ways of treating it. To refer samples or for additional information, contact Lisa G. Rider, MD, Deputy Chief Environmental Autoimmunity Group, NIEHS, NIH, Building 10, Room 4-2352, 10 Center Drive, MSC 1301, Bethesda, MD 20892-1301 Phone: 301/451-6272 Fax: 301/451-5588 or 301/402-2855 Email: riderl@mail.nih.gov

Juvenile Rheumatoid Arthritis Affected
Sib-pair (JRA-ASP) Registry
This registry is located at Children's Hospital Medical Center in Cincinnati and is sponsored by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) of the National Institute of Health (NIH). The registry enrolls families with two or more children diagnosed with JRA according to ACR criteria, from the US and Canada. We have 162 families enrolled in the JRA Affected Sib-pair Registry, as of March 2002, thanks to the effort of the participating families and their physicians. Our goal is to collect 200 ASP families. The main aim of the registry is to make available to the scientific community this large, unique population of JRA families. DNA samples are available for the majority of registry participants. Investigators interested in working with this population can contact the registry manager by phone (513/636-7389) or e-mail (marta.moroldo@chmcc.org) for further information or to obtain a project application.

Registration process:
After a physician identifies a family that qualifies for the registry, he/she obtains their permission to inform the registry. Enrollment requires the following documentation:
1. Completed consent from the family to indicate willingness to participate in the registry.
2. A questionnaire from the family regarding medical history of the JRA affected members.
3. A questionnaire that is completed by the physician.
Strict confidentiality is maintained by limiting access to the registry database, the use of passwords and providing unique numeric identifiers for study participants.

David Glass, MD; Principal Investigator
Marta Moroldo, MD; Registry Manager
Edith Shear, Study Coordinator

Index - Section on Rheumatology