Currently Enrolling

ADDRESS II Study

Study Summary:
This study is looking at the safety and efficacy of an investigational drug (atacicept) for lupus that acts on certain cells in your immune system known as B cells, which are believed to play an important role in lupus. It is given as a weekly injection under the skin which can be done at home. The goal is to provide a new option for lupus that reduces lupus symptoms and the need for other lupus medications.

You may be eligible to take part if you:
• are 18 years of age or older,
• have met the requirements for a lupus diagnosis for 6 months or more,
• currently experiencing active lupus disease and symptoms,
• are to provide medical documentation of lupus diagnosis and historical records from a previous or current rheumatologist,
• are able to attend a 3 hour morning “screening visit” at the Hospital for Special Surgery (“HSS”) to determine full eligibility,
• are able to attend regular study visits if determined eligible. The study is comprised of 12 visits after screening, each lasting 30-60 minutes, as follows:
• Four (4) almost-weekly morning visits, during the first study month,
• Five (5) monthly visits for the remaining 5 months of the treatment period,
• Three (3) visits over the last 6 months after the treatment period for health assessments.

If you fulfill the above criteria and would like to enroll, or for more information, please contact:
Glendalee Ramón
Clinical Research Coordinator
Hospital for Special Surgery
535 East 70th Street
New York, NY 10021
212-774-2808
ramong@hss.edu

Cellcept (MMF) Withdrawal Study

Study Summary:
The purpose of this study is to find out if patients who have consistently been on MMF for 1 to 2 years and whose lupus disease is quiet can safely stop their MMF medication. Doctors know that continuing MMF for long periods of time can have side effects and they know that stopping MMF will put you at a higher risk for flare; we are trying to find out how big this risk is and if it is better to stop or continue taking MMF.

If eligible, you will be randomly assigned (like with a flip of a coin) to one of two groups. You have an equal chance of being in either one of these groups:
• MMF continuation group (half of those who join the study) will continue MMF at a set dose
• MMF withdrawal group (half of those who join the study) will be slowly tapered off their MMF over 3 months

You may be eligible to take part if you:
• 18-65 years of age,
• have been on the same dose of MMF (1000-3000 mg/day) for at least 12 weeks, without interruptions,
• have been on MMF continuously for at least one (1) year, if taken for reasons not related to the kidney,
• have been on MMF continuously for at least two (2) years, if taken for kidney related reasons,
• have been on a stable dose of hydroxycloroquine (HCQ & also known as Plaquenil), or chloroquine for the past 12 weeks, without interruptions.

If you fulfill the above criteria and would like to enroll, or for more information, please contact:
Glendalee Ramón
Clinical Research Coordinator
Hospital for Special Surgery
535 East 70th Street
New York, NY 10021
212-774-2808
ramong@hss.edu

Allure Study

The purpose of this study is to evaluate (Abatacept) for treatment of lupus nephritis when used on a background of Cellcept (mycophenolate) and prednisone (corticosteroids).

Inclusion Criteria:
•Systemic Lupus Erythematosus (SLE) as defined by meeting at least 4 of the 11 classification criteria of the American College of Rheumatology for the classification of Systemic Lupus Erythematosus, either sequentially or coincidentally
•Urine protein creatinine ratio (UPCR) ≥ 1.0 at Screening
•Biopsy within 12 months prior to screening visit indicating active proliferative lupus glomerulonephritis International Society of Nephrology (ISN)/ Renal Pathology Society (RPS) 2003 classification Class III or IV [excluding Class III (C), IV-S (C) and IV-G (C)] or World Health Organization (WHO) 1982 Classification Class III or IV (excluding IIIc, IVd)
•Evidence of active disease within 3 months of Screening

Hospital For Special Surgery
Recruiting Status: Recruiting
Kyriakos Kirou
New York, New York
212-774-2967

For more information on this study please click here.

Brany Study

You may be interested in participating in a research study of an investigational drug for the treatment of Lupus Nephritis

Sponsored by The SLE and Autoimmune Disease Treatment Center

Division of Rheumatology and Allergy-Clinical Immunology
North Shore-LIJ Health System
516 – 708 – 2558