Caring for patients with moderate to severe systemic lupus erythematosus?
Talk to your patients about GARDENIA-SLE
About the study
GARDENIA-SLE is a phase 3, randomized clinical research study to assess the efficacy and safety of an investigational medicine in participants with moderate to severe systemic lupus erythematosus (SLE) commonly called lupus. The efficacy and safety of the investigational medicine have not been established.
About 600 participants will take part in GARDENIA-SLE at approximately 260 sites worldwide.
Who is eligible to participate?
Eligible participants:
- Are 18 to 75 years old
- Have been diagnosed with lupus for at least 24 weeks
- Must have a systemic lupus erythematosus disease activity index 2000 (SLEDAI-2K) score >= 6 and a clinical SLEDAI-2K >= 4 at screening
Additional criteria will apply.
Pre-screening questionnaire
This questionnaire does not contain all of the requirements potential participants need to meet to participate. Please click on the answer that best applies.
What happens during the study?
- The main part of the study lasts about 1 year (double-blind, placebo-controlled), with an option to join a 2-year extension study (open-label)
- Eligible participants will be randomized 3:2 to receive the investigational medicine or placebo
- All participants will receive their investigational medicine or placebo weekly by subcutaneous injection
- Participants are allowed to take the investigational medicine or placebo at home if they qualify for this
All participants will receive:
- Medication and medical care required by the clinical research study at no cost
- Reimbursement for travel and expenses required by the clinical research study
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