Lupus Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You have been diagnosed with systemic lupus erythematosus (SLE) using the 2019 international classification guidelines
• You are between 18 and 65 years old
• You weigh at least 40 kg (about 88 lbs)
• Your SLE has remained active or gotten worse even after trying standard treatments, including steroids, immunosuppressant medications (such as cyclophosphamide or mycophenolate mofetil), and biologic drugs (such as belimumab or rituximab)
• You are currently on one or more stable SLE treatments, such as steroids, antimalarial drugs, or immunosuppressants, at doses that have been steady for a required period before joining (confirm with trial site for exact timing requirements)
• Your lupus disease activity score (SLEDAI-2K) is 10 or higher, meaning your disease is considered significantly active
• If you are a woman who could become pregnant, you tested negative for pregnancy before the trial starts and agree to use effective contraception throughout the trial until the last follow-up visit
• If you are a man whose partner could become pregnant, you agree to use effective contraception throughout the trial until the last follow-up visit
• You are willing to participate and have signed a consent form agreeing to take part

Who may not be able to join:

• You have a life-threatening condition related to lupus or another serious illness, such as severe kidney failure, severe nervous system complications, or a dangerous blood-clotting condition (confirm with trial site)
• You have a history of alcohol or drug misuse in the past 24 weeks
• You have a history of cancer, other than a specific type of blood cancer called B-cell lymphoma
• You had a major surgery (including joint surgery) within the past 24 weeks, or you are planning to have surgery within 24 weeks of joining the trial
• You have another overlapping connective tissue disease that could make it difficult to accurately measure your lupus activity
• You have HIV, certain immune deficiencies, chronic hepatitis B or C, T-cell deficiency virus infection, or a current COVID-19 infection
• You have an active tuberculosis (TB) infection or an active bacterial infection
• You have had a heart attack, heart stent procedure, unstable chest pain, significant irregular heartbeat, or other serious heart condition in the past 6 months
• You have had a serious blood clot in a vein or in your lungs in the past 6 months
• Your liver function blood test results are significantly above the normal range (confirm with trial site for specific values)
• Your kidney function is severely reduced, or your blood shows certain serious abnormalities such as very low red blood cells, white blood cells, or platelets (confirm with trial site for specific values)
• You have been treated with a type of medication called a CD20 monoclonal antibody (such as rituximab) within the past 6 months
• The trial doctor has another reason they feel makes it unsuitable for you to participate

Important: Always verify eligibility with the trial site directly before applying.