Research

A Phase 3 Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy & Safety of MBS-188667 (Abatacept) or Placebo on a Background of Mycophenolate Mofetil (MMF) & Corticosteroids in Subjects with Active Class III or IV Lupus Nephritis (ALLURE Study)

IRB Number: 13126

Institutional Review Board, Hospital for Special Surgery

April 03, 2014

The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.

Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.

For further information, see Understanding Clinical Trials.

Principal Investigator

Kyriakos A. Kirou, MD, DSc, FACP

Co-Investigators

James Chevalier, MD

Summary

The purpose of this study is to see if the investigational use of abatacept (also called Orencia®) is better than placebo for the treatment of lupus nephritis when used in combination with background treatment. Background treatment will be used by all subjects. Background treatment will include CellCept® and glucocorticoids (examples include prednisone, prednisolone, and methylprednisolone). Abatacept has been approved for the treatment of rheumatoid arthritis (RA) in adults. The use of abatacept remains an investigational drug for use in other diseases.

About 400 patients are expected to participate in this study, from about 120 sites around the world. Approximately 3 patients from the Hospital for Special Surgery will participate in the study. Patients will be randomly assigned and will have a 50% chance of being placed into one of the following two groups:

Group 1: Patient will receive abatacept every 28 days and CellCept
Group 2: Patient will receive placebo every 28 days and CellCept

Your participation will involve approximately 31 study visits. Most visits are expected to last between 1 ½ and 3 hours. Follow up visits are expected to last 30 to 60 minutes.
Study participation is voluntary and is expected to last up to 2 1/2 years that include:
• Up to 5 week screening period (1-2 visits)
• 24 month treatment period (26 visits)
• 6 month follow-up period (2 visits)

Inclusion/Exclusion Criteria

The purpose of this study is to see if the investigational use of abatacept (also called Orencia®) is better than placebo for the treatment of lupus nephritis when used in combination with background treatment. Background treatment will be used by all subjects. Background treatment will include CellCept® and glucocorticoids (examples include prednisone, prednisolone, and methylprednisolone). Abatacept has been approved for the treatment of rheumatoid arthritis (RA) in adults. The use of abatacept remains an investigational drug for use in other diseases.

About 400 patients are expected to participate in this study, from about 120 sites around the world. Approximately 3 patients from the Hospital for Special Surgery will participate in the study. Patients will be randomly assigned and will have a 50% chance of being placed into one of the following two groups:

Group 1: Patient will receive abatacept every 28 days and CellCept

Group 2: Patient will receive placebo every 28 days and CellCept

Your participation will involve approximately 31 study visits. Most visits are expected to last between 1 ˝ and 3 hours. Follow up visits are expected to last 30 to 60 minutes.

Study participation is voluntary and is expected to last up to 2 1/2 years that include:
• Up to 5 week screening period (1-2 visits)
• 24 month treatment period (26 visits)
• 6 month follow-up period (2 visits)

Contact Information

Margaret Robotham
robothamm@hss.edu
212.774.2967



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