APATURA
Sponsor Name:
Sanofi
Purpose of Study:
Sanofi APATURA study for patients with moderate to severe SLE
The APATURA study is testing a new potential medication in SLE patients who are currently taking medications for SLE and still experience SLE symptoms.
You may participate in the study if you:
- Are between the ages of 18-70
- Were diagnosed with lupus at least 6 months ago
- Take medications to treat SLE but still have symptoms
You cannot participate in this study if you:
- Are pregnant, lactating, breastfeeding, or planning pregnancy during the study period
- Have any of the following conditions in addition to SLE:
- Rheumatoid arthritis
- Ulcerative colitis
- Crohn's disease
- Have used cyclophosphamide in the 3 months before your screening visit, or received treatment with rituximab in 12 months before the study begins
If you are interested in this study and meet the qualifications, you may have a screening visit with a study doctor. The study doctor will decide if you are able to be part of the study.
The purpose of the APATURA study is to study whether a new drug that is being developed is safe and can decrease lupus activity when it is taken with other lupus medicines.
What will happen during the study?
If you participate in the study:
- The study will last 40 weeks. During that time, you will make up to 17 visits to the study site, with the possibility of home visit/phone call for specific visits.
- You will keep taking your current SLE medications during the study.
- You will receive either active study medication or placebo (which looks like the study medication but contains no active medication)
You or your insurance will not have to pay for any study-related care or the study medication.
Study Type:
- Interventional (Clinical Trial)
- Phase II
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. If you are a person living with lupus or a caregiver and you want to learn more about clinical trials and other research opportunities that may be right for you or your family member living with lupus, sign up for the Lupus Foundation of America’s Research Accelerated by You (RAY®) online patient and caregiver registry, if you have not already done so. Compensation is available.