• Clinical Studies

    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. 

    About Clinical Studies

    Clinical trials are research studies that involve patients to answer specific questions about new treatments or new ways of using known treatments. Carefully conducted clinical trials are the fastest and safest way to determine whether new drugs or other treatments work in people.

    In clinical trials, one group of participants receives the experimental drug while another group, the control group, gets standard treatment or an inactive treatment known as a placebo. Studies that include control groups are known as controlled trials.

  • There are four phases of clinical trials:

    • Phase I tests a new drug or treatment in a small group to see how the drug works in the human body, if there are side effects with increasing doses, and to gain early evidence the drug is effective.
    • Phase II tests the new drug or treatment in a controlled trial, with one group of patients getting the experimental drug and another group getting standard treatment, or a placebo.
    • Phase III tests the new drug or treatment in expanded controlled and uncontrolled trials to get additional information to evaluate the treatment's overall benefits and risks and to use for the medication label.
    • Phase IV continues to test the drug after it has been licensed and marketed to get more information on its risks, benefits and best ways to use it.

    In addition to investigating new treatments for lupus, clinical trials may also look for better ways to prevent lupus, better tests or procedures for detecting and diagnosing lupus, and ways to improve the quality of life for people who have lupus.

    By participating in a clinical trial, you can gain access to new research treatments before they are widely available and help others by contributing to medical research. All clinical trials have guidelines and eligibility criteria designed to make sure the participants will be safe and the study will be valid and answer the research questions.

    If you express interest in joining a clinical trial at Cincinnati Children's Hospital Medical Center, you will receive an informed consent document describing your rights as a study participant. The consent also includes details about the study, such as its purpose, how long it will last, what is required of participants, risks and potential benefits. Based on that information, you can decide whether or not to sign the document and participate in the trial. The document is not a contract and you can withdraw from the study at any time.

    Clinical researchers at the Lupus Center at Cincinnati Children's can review and explain clinical trials and let you know about new and upcoming studies. If you have questions, ask one of our researchers or another member of the Lupus Center health care team.

    Each of these sites lists more than 100 clinical trials dealing with lupus, along with a brief description of each, and how to get more information.