Thank you for your interest in this study.
The standard line of therapy for LN has included the use of corticosteroids in conjunction with cytotoxic or immunosuppressive drugs, however new investigational options are currently being explored.

The primary objectives for this study are to assess the effectiveness of the investigational medication, versus a comparator medication, for inducing response in patients with LN, and to assess the long-term effectiveness of the investigational medication, versus a comparator medication, in maintaining remission and renal function in patients with LN. The Investigational medication has already been approved by some National Drug Regulatory Authorities for other uses and has also been tested in several small studies of patients with LN.

About Patient Participation
To pre-qualify for this study, a patient must:
• Be 12 to 75 years of age,
• Be diagnosed with SLE, and
• Have had a kidney biopsy in the last 6 months confirming LN.

Qualified participants will receive a study-related medical evaluation and investigational medication at no cost. Reimbursement for travel will also be provided. The entire study includes two phases. An eligible patient who decides to participate in the study will first enter the 6-month induction phase - the “illness control” portion of the study – where treatment with corticosteroids, plus either the investigational medication or a comparator medication, will be provided in order to stabilize the patient’s LN. In total, a study participant will visit the clinic a minimum of 9 times during the 6-month induction phase.

If stabilization is achieved, the participant will then enter the 3-year maintenance phase where treatment with corticosteroids, plus either the investigational medication or a comparator medication, will be provided. In total, a participant will visit the clinic a minimum of 12 times during the 3-year maintenance phase. During the clinic visits, various medical tests and evaluations will be performed to determine patient eligibility and progress throughout the study. These tests and evaluations will include, but not be limited to, study-related medical examinations and the collection of blood samples. Each visit will last 2-4 hours and vary in length, depending on the study requirements for that particular visit.
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About the Study
The primary objectives for this study are two-fold:
1. To assess the effectiveness of the investigational medication, versus a comparator medication, for inducing response in patients with LN, and
2. To assess the long-term effectiveness of the investigational medication, versus a comparator medication, in maintaining remission and renal function in patients with LN.

During the induction phase, both the participants and the study staff will know which drug treatment group is assigned. The maintenance phase of the study is double-blinded – neither the study staff nor the participant will know which group is assigned. However, if a medical problem arises, this information will be provided.
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Patient Risks & Benefits
As with any medical research study, there are risks associated with patient participation. While the investigational medication is being evaluated for its ability to effectively treat LN, it is possible a patient’s condition may not respond to the study treatment or a patient may also experience an adverse reaction from the investigational medication. The primary adverse reactions associated with the administration of the investigational medication include gastrointestinal intolerance (nausea, diarrhea, vomiting), leukopenia, and infections. As with all immunosuppressive regimes, long-term use increases the risk of lymphoma and other malignancies.

It is also possible that a participant may benefit by joining the study. Their condition could improve, but this cannot be guaranteed. At a minimum, a participant will have access to medical care options and diagnostic tools used in the treatment of LN (at no cost to the participant).
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