Lupus Studies
Ongoing Studies at Cincinnati Children's
Several clinical and translational studies, including clinical trials at Cincinnati Children's Hospital Medical Center, are recruiting patients with lupus. Patients who decide to take part in studies usually need to have blood work and other tests and complete questionnaires. Whenever possible, blood work for research studies will be done at the same time as clinic blood draws so all blood needed can be collected using one needle stick. The research personnel at the Lupus Center can help with these tasks and will coordinate your research participation with the overall care you receive from the Lupus Center health care team.
Overview of Studies at Cincinnati Children's
Follow the links to the study summaries to get more information, find out who is eligible to participate and how to sign up for a study.
Lupus APPLE Study
The purpose of this study is to find out whether or not a drug called Atorvastatin (Lipitor) will lower lipid levels, decrease inflammation, and lessen heart, stroke and circulatory problems in children with systemic lupus erythematosus (SLE). Contact study coordinator: Jamie Eaton, jamie.eaton@cchmc.org, 513-636-0395.
Lupus Database
The purpose of this study is to create an electronic database of patients diagnosed with systemic lupus erythematosus (SLE). This database will serve as a resource list of patients to contact for clinical trials of new medicines. People listed in the database will be individually contacted about trials they may be eligible for and then have the choice of whether or not to participate. Data to be collected include name, date of birth, address, phone number, clinical information from medical records and from questionnaires completed by physicians and patients. No blood tests are required. Contact study coordinator: Jamie Eaton, jamie.eaton@cchmc.org, 513-636-0395.
Clinical Trials Outcome Measures for Lupus
The purpose of this study is to learn how to best measure whether a new medication being tested for use in children and adolescents with lupus is truly working and is safe. The goals are to define important changes in disease activity, and come up with unified definitions of the terms flare, remission and clinically important improvement of disease. Data will be gathered from medical records and questionnaires. No experimental medicines, treatments, procedures or additional blood draws are involved. This study requires up to two visits over a period of six months. Contact study coordinator: Jamie Eaton, jamie.eaton@cchmc.org, 513-636-0395.
Biomarkers for Systemic Lupus Erythematosus (SLE) Renal Disease
This study is looking at why the kidneys are more likely to be affected in SLE that starts in childhood than in SLE first diagnosed in adults. Data will be gathered from medical records and questionnaires. No experimental medicines, treatments or procedures are involved, although blood and urine samples are required. Study participants will need to visit the Lupus Clinic 7 times over a period of 18 months. Contact study coordinator Jamie Eaton, jamie.eaton@cchmc.org, 513-636-0395.
Cellcept for Systemic Lupus Erythematosus (SLE) Renal Disease
The purpose of this study is to find out the best dose of mycophenolate mofetil (CellCept") to help control symptoms of SLE in children and young adults. The study will require three study visits over a period of six months, a screening exam on the first visit, completing help questionnaires at each visit, keeping and turning in a drug diary, and blood samples. Contact study coordinator: Jamie Eaton, jamie.eaton@cchmc.org, 513-636-0395.
Use of Triptorelin to Protect the Ovaries of Patients With Systemic Lupus Erythematosus (SLE)
The purpose of this study is to test the safety of a drug called triptorelin (Trelstar") when used to protect the ovaries (female reproductive organs) during cyclophosphamide therapy for systemic lupus erythematosus (SLE). This is an intervention trial, which means it involves treatment, in this case getting injections of triptorelin or a placebo, an inactive substance. Neither the patients nor the staff members will know who is receiving the drug and who is getting the placebo. The study requires 23 visits over 23 months. All visits will include an examination by a physician, an evaluation for side effects, questionnaires and review of study diaries. Other requirements include blood and urine samples, ultrasounds of the ovaries and bone density scans. Contact study coordinator: Shannen Nelson, shannen.nelson@cchmc.org, 513-636-5484.
Puberty Study
This study addresses the question of how hormonal changes in puberty affect lupus in girls who have been diagnosed with lupus. The study includes visits every 3 months over an approximate three-year period, blood draws and urine samples. Physical examinations are performed and questionnaires completed. Contact study coordinator: Jamie Eaton, jamie.eaton@cchmc.org, 513-636-0395.
Ovary Protection Medication Study
The purpose of this study is to determine the safety and effectiveness of an ovary protection medication (triptorelin), and its dosage and the time necessary to suppress ovaries to protect them against harmful effects of chemotherapy used in treating lupus. Contact study coordinator: Shannen Nelson, shannen.nelson@cchmc.org, 513-636-5484.
