Treatments
Rheumatology Research
Children's Hospital of Wisconsin and Medical College of Wisconsin staff conducts research to improve care for children and adolescents with rheumatic diseases.
Basic science research program
The Pediatric Rheumatology Section of the Medical College of Wisconsin (MCW) has an active basic science research program funded by the National Institutes of Health (NIH) and other public and private foundations, including the Children's Hospital and Health System Foundation and Children's Research Institute. Research efforts are focussed on autoimmunity, T-cell development and T-cell tolerance.
Clinical studies center
The section's clinical studies center, partially funded by the Children's Hospital and Health System Foundation, is located in the Pediatric Rheumatology Clinic at Children's Hospital of Wisconsin. Clinical studies offer opportunities for patients and families to participate in a variety of different types of research trials in which drugs and other novel treatments are studied and validated in children with a wide range of rheumatologic conditions. Our center collaborates with pediatric rheumatology research consortiums including the Pediatric Rheumatology Collaborative Study Group (PRCSG) and the Childhood Arthritis and Rheumatology Research Alliance (CARRA). These consortiums are comprised of board-certified pediatric rheumatologists at academic medical centers around the world. This collaboration allows our clinical trials center to offer high quality studies to our patients and families that would not be possible for one regional center alone to conduct. Our center's participation in pharmaceutical studies has also led to FDA-approval of new drugs that have dramatically improved outcomes and quality of life for children with juvenile rheumatoid arthritis (JRA).
Current clinical studies that are open to patients and/or family members include:
"Triptorelin for Ovary Protection in Childhood Onset Lupus"
- Sponsor: Food and Drug Administration
- MCW Principal Investigator: Calvin B. Williams, MD, PhD
- Eligibility: Non-pregnant female patients between 9 and 21 who newly require chemotherapy for severe lupus may be eligible.
- The purpose of this study is to determine if the drug triptorelin can reduce the risk of cyclophosphamide (CTY) induced infertility and premature menopause in female patients with SLE. It is hypothesized that triptorelin may be useful in protecting the ovaries of patients receiving CTY. The study will also seek to determine the appropriate dose regimen for triptorelin, and any potential side effects regarding disease activity in patients receiving this medication.
"Juvenile Rheumatoid Arthritis Immune Response to Flu Shot Study"
- Sponsor: National Institutes of Health
- Eligibility: Up to 70 children with JRA taking immunosuppressive medication and up to 70 children not taking immunosuppressive medication.
- What is involved:
1) Interested families will be asked to sign HIPAA authorization and consent forms following full explanation of the study.
2) Screening: Health-related questions will be asked and a buccal swab (brushing of the inside of the cheek to collect cells) to determine Human Leukocyte Antigen (HLA) type. HLAs are proteins on the surface of cells that allow your body's immune system to tell the difference between your own cells and foreign cells. Our bodies use these proteins to identify viruses and bacteria.
3) Up to Nine Study Visits: Only children who have the HLA proteins that the researchers are studying will be asked to come to Children's Hospital up to 9 times over a 3-year period for flu shot(s) and blood tests. Children who participate in the study will be asked to have study procedure about every 6 months, with additional procedures, 2-6 weeks after their yearly flu shot. Also at each visit, a parent will be asked to answer questions about their child's health. Study procedures usually will be able to be scheduled at same time as Children's Hospital Rheumatology Clinic follow-up and lab visits for clinical care. Procedures done specifically for the study will be paid from NIH funds.
- Purpose: The purpose of this study is to collect information on how the bodies of children with JRA respond to the influenza vaccine (flu shot) when they are also taking medications that are known to decrease the body's ability to fight off infections. This information will be compared to information collected on children who are not taking these medications.
- Benefit: This is the first study designed to find out how the bodies of children with JRA who are taking immunosuppressive medication respond to the flu vaccine, as compared to children who are not taking these medications. We do not expect this study to benefit participating children directly, as is unlikely the researchers will find out any specific information that would be of benefit to the child(ren). However, if something important is found, your pediatric rheumatologist will discuss the findings with you.
"Study of long term safety of a Biologic DMARD compared to MTX in polyarticular JRA"
- MCW Principal Investigator: Judyann C. Olson, MD
- Eligibility: Children 2-17 years old with JRA and active arthritis.
- The purpose of this three-year study is to evaluate long-term safety of a recently FDA-approved biologic response modifier in children with active polyarticular and systemic JRA.
"Genetics of Pediatric-Onset Systemic Lupus"
- Sponsor: National Institutes of Health
- MCW Principal Investigator: James J. Nocton, MD
- Eligibility: Children diagnosed with lupus prior to the age 16, who have two biological parents and/or one parent and one biological sibling also willing to participate.
- The purpose of this study is to determine if specific genes are associated with susceptibility to systemic lupus erythematosus (SLE). It is hypothesized that several genes will be found that are associated with the phenotype of SLE. The specific aim is to screen a large population of children with systemic lupus erythematosus and their families and perform genetic analyses to identify associated phenotypes.
"Gene Expression Profiles in Pediatric Arthritis"
- Sponsor: National Institutes of Health
- MCW Principal Investigator: Judyann C. Olson, MD
- Eligibility: Children 1-16 years of age with a new-onset diagnosis of pauciarticular or polyarticular JRA or JspA and their first and second-degree relatives. Also previously diagnosed children with systemic onset JRA who develop macrophage activation syndrome.
- The main purpose of this study is to establish the genetic basis for juvenile rheumatoid arthritis (JRA) and juvenile spondyloarthropathy (JspA). Integrated genomics will be used to identify 3 elements that are likely to have a genetic basis: 1-susceptibility, 2-clinical outcome and 3-responses to treatment. Specific aims are to examine differences in gene expression profiles seen in peripheral blood, joint fluids and synovial tissues in children with JRA and JspA and to identify changes in gene expression with introduction of therapy with methotrexate (MTX) and/or biologic therapy.
For more information:
Please contact Marsha Malloy, RN, BSN, MBA, CCRC, pediatric rheumatology research nurse at (414) 266-6700 if you have any questions or would like more information about these research studies.
Publications related to our clinical research studies include:
Lovell DJ, Giannini EH, Reiff A, Cawkwell GD, Silverman ED, Nocton JJ, Stein LD, Gedalia A, Ilowite NT, Wallace CA, Whitmore J, Finck BK for the Pediatric Rheumatology Collaborative Study Group (PRCSG): Etanercept in children with polyarticular juvenile rheumatoid arthritis. N Eng J Med 2003; 763-9.
Lovell DJ, Giannini EH, Reiff A, Jones OY, Schneider R, Olson JC, Stein LD, Gedalia A, Ilowite NT, Wallace CA, Lange M, Finck BK, Burge DJ , for the Pediatric Rheumatology Collaborative Study Group (PRCSG): Long-term efficacy and safety of etanercept in children with polyarticular-course juvenile rheumatoid arthritis. Arthritis & Rheumatism, 48(1): 218-226, 2003. |
