Systemic Lupus Erythematosus

SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)

Medication Usage

Therapeutics

 

Physical and Mental Health and Medication Use among Patients with Lupus

Principle Investigator:  Candace Feldman, MD, MPH
Contact:  David Kreps, MS (617-525-8785, dkreps@partners.org)
Funding Agency:  Rheumatology Research Foundation

Study Summary:  We are conducting a 6-8 month research study to understand changes in mental and physical health and medication use among patients with lupus over time. Participants will complete a total of 3 visits (1 baseline visit and 2 follow-up visits) and every effort will be made to have these visits coincide with your regularly scheduled rheumatology appointments.

Subject Criteria:

  • 18 years or older.
  • Receive rheumatology care at Brigham and Women’s Hospital, Faulkner Hospital or 850 Boylston.
  • Take a medication for lupus, newly prescribed in the past 12 months, or have a diagnosis of lupus in the past 2 years.
  • English speaking.

Visit summary:

  • One Screening and baseline visit (Month 0).
  • Two follow-up visits (Between months 3-4 and again between months 6-8).
  • You may also be asked to participate in a focus group discussion.

Additional Information:

  • Study visits will be scheduled to coincide with your normally scheduled clinic visits.
  • This will not affect the care you receive; however with your permission, we may ask you whether we can convey survey results to your rheumatologist if we will feel it will benefit your care.

Patient Remuneration:  You will not be paid for participating, but your parking will be covered for the study visits.

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BLISS (Belimumab International SLE Study - Subcutaneous)

Principle Investigator: Elena M Massarotti, MD
Contact: Jade Cumberbatch (nhcumberbatch@partners.org; 617-732-5354)

Funding Agency:  Human Genome Science

Study Summary:  We are conducting a one year and a half long study to determine whether belimumab (BENLYSTA), an FDA approved drug, is effective at treating systemic lupus erythematosus. It is normally administered intravenously, but we are testing whether or not it can be taken subcutaneously without causing too many side effects.

Patient Criteria:  Patient must have systemic lupus and experience active symptoms.

Visit Summary: This study is divided into two parts, that if completed, will take about 1 ½ years. During both portions you will receive a physical, answer questionnaires, be given belimumab to administer at home, and have some lab work done (blood will be taken from screen to study termination to monitor for any abnormalities).

• Part 1: The main part of the study will last about 1 year (52 weeks). During this   time, we will ask you to make about 17 study visits to BWH.
• Part 2: If you complete Part 1, you will be able to continue to take part in the study for an additional 6-month. During this time, we will ask you to make about 7 study visits to BWH.  Part 2 is the open-label extension study which means that all participants will receive belimumab (there will be no placebo).

Patient Remuneration: $150 for the first two visits, $75 for each visit you complete thereafter.

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EMBRACE (A Phase 3/4, Multi-Center, Randomized, Double-Blind, Placebo Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) in Adult Subjects of Black Race with Systemic Lupus Erythematosus (SLE)

Principle Investigator: Elena M Massarotti, MD
Contact: Jade Cumberbatch (nhcumberbatch@partners.org; 617-732-5354)

Funding agency: Human Genome Sciences, Inc

Study summary: We are doing this research study to find out if belimumab (also known as BENLYSTA) can help people of black race with lupus. This research study will compare belimumab to placebo. 

Patient criteria: Adults black race who have Systemic Lupus Erythematosus; SLE.

Patient remuneration: We will pay you $150 for the first two infusions, $75 for the remaining study visits that include an infusion, and $25 for other study visits.   If you complete Part 1 you will be reimbursed $1200 and if you complete Part 2 you will be reimbursed $450.  We will also give parking vouchers to subjects as needed.

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