Note: This study is currently only recruiting patients in the hospital.
If you are interested in being notified if this study begins recruiting from the general population, please use the 'I Am Interested' button below.
Mycophenolate Mofetil alone or with Voclosporin for Systemic Lupus Erythematsus (SLE)
This project is not recruiting.
Who can participate
Generally, participants are eligible for this research study if they meet all of the following eligibility criteria: About 120 participants will be in this study at about 15 study sites in the United States.
Rheumatology (EULAR/ACR) 2019 criteria for SLE
Who cannot participate
Generally, participants are NOT eligible for this research study if they meet any of the following exclusion criteria: Additional exclusionary criterion may deem interested participants ineligible for this research study. Full eligible will be reviewed and confirmed prior to the initiation of the official Screening in Stage 1.
What you may be asked to do
Total maximum duration of this study is 56 weeks. If you choose to take part in this study, you will need to sign and date the informed consent form before we do any study procedures. This study is divided into three stages: _______________________________________________________________________________________________ Stage 1: Screening Lupus Medicaion Withdrawl Once you have signed and dated the informed consent form, the screening phase of the study is started. Your study team can tell you how long this visit will take. You will be in the screening phase for up to 28 days. In order to join this study, you must have completed a COVID-19 vaccination series with the last shot given at least 14 days prior to the screening visit. The following will happen during Stage 1: Stage 2: Randomization to MMF or placebo If you qualify for Stage 2, you will be assigned randomly (like flipping a coin, 50/50 chance) to receive either MMF or placebo. Neither you nor the study doctors will know what you are taking. The first few weeks we will slowly increase the dose of MMF to avoid side effects. Once you are on full dose of MMF/placebo you will take this study drug for up to 48 weeks or as long as your lupus remains quiet. The following will happen during Stage 2: If you are doing well on the study drug (MMF or placebo), you will stay in Stage 2 for up to 48 weeks. If your illness begins to worsen at any time during the first 24 weeks of Stage 2, you and your study doctor will discuss moving into Stage 3. Prior to moving into Stage 3, if you and the study doctor think that another steroid shot is likely to help you, you can be given another shot. After this steroid shot you will move to Stage 3 of the study. If your illness begins to worsen at any time during the first 24 weeks of Stage 2 and the study doctor thinks that another steroid shot would not be sufficient to help you, you will stop the study drug and new lupus medication will be provided to you outside of the study. You will continue to have study visits until week 24 or 4 weeks after the last dose of study drug, whichever is longer. If your illness begins to worsen after week 24 of the study, you will stop the study drug and new lupus medication will be provided to you outside of the study. You will be scheduled to have one final study visit four weeks after you stopped the study drug. Stage 3: Re-randomization to MMF and voclosporin or MMF and placebo If you qualify for Stage 3, you will be assigned randomly (like flipping a coin, 50/50 chance) to receive either MMF and placebo or MMF and voclosporin. Neither you nor the study doctors will know which of these you are taking. If you were taking placebo during Stage 2, we will slowly increase the dose of MMF to avoid side effects exactly like we did in Stage 2. All participants will take voclosporin 23.7mg twice a day. If during the first two weeks of Stage 3 you and the study doctor think that another steroid shot is likely to help your symptoms, you can be given another shot. If your illness does not get worse, you will be in Stage 3 for up to 28 weeks. The following will happen during Stage 3: During Stage 3, If your lupus worsens and requires additional medication, you will be taken off the study drug and start the new medication outside of this study. You will be scheduled to come back for a stopping study visit four weeks after stopping study drug.
Project activities may include:
- Survey
- Blood draw
- Injection or IV
- Office visit
- Personal health tracking
- Medication
Estimated Time Commitment
15 visits over 56 weeks
What You May Get
You will be paid up to a total of $280.00 if you complete this study. You will be paid for the visits you complete according to the following schedule: $20.00 for Screening Week Visit. If you do not complete the study, for any reason, you will be paid for each study visit you do complete. You will be paid following each completed visit. If you have any questions regarding your compensation for participation, please contact the study staff. We will reimburse you for the cost of a meal during study visits, up to $20.00 per study visit. Meal receipts must be submitted to the study staff. You will be reimbursed approximately 2 weeks after you submit your travel receipts to the study staff.
$20.00 for Baseline Visit
$20.00 for Week 4
$20.00 for Week 8
$20.00 for Week 12
$20.00 for Week 16
$20.00 for Week 20
$20.00 for Week 24 or Stage 3-1
$20.00 for Week 28 or Stage 3-3 (Week 4)
$20.00 for Week 32 or Stage 3-4 (Week 8)
$20.00 for Week 36 or Stage 3-5 (Week 12)
$20.00 for Week 40 or Stage 3-6 (Week 16)
$20.00 for Week 44 or Stage 3-7 (Week 20)
$20.00 for Week 48 or Stage 3-8 (Week 24)
Location
Massachusetts General Hospital
55 Fruit Street, Yakwey 4B, Boston, MA 02114
Travel
- Accessible by public transportation
- Parking available
Travel and Parking Details
Massachusetts General Hospital (MGH) is accesible by public transit on the MBTA, by bus or train (the Red Line). Valet parking will be at a higher premium.
Parking at MGH is available at a cost at multiple visitor parking garages. Parking will not be reimbursed. MGH parking available at garages around the hospital buildings, including the Fruit Street, Parkman Street and Yawkey Center parking garages. Validated patient & visitor parking rates:
Additional Information
Study Phase
Phase 2: This project studies whether a medication or treatment works for people with a specific disease or condition. The drug or treatment has been studied for safety in healthy volunteers, but the project will continue to look at safety and short term side effects.
Funding Source
- NIH or Other Federal