A Phase 2 Dose Ranging Study to Evaluate the Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) With Inadequate Response to Standard of Care (SOC) Therapy

Date Added
December 8th, 2020
PRO Number
Pro00102184
Researcher
James Oates

List of Studies


Keywords
Autoimmune disease, Lupus
Summary

The purpose of this study is to determine if investigational (not FDA approved) drug AMG570 can be an effective treatment for patients with Systemic lupus erythematosus (SLE) that are not responding well to their current standard of care therapy. This study will compare 3 dose levels with placebo (A placebo looks like the study drug, but the injection does not contain the active ingredient) to determine the ideal therapeutic dose. You will have 32 scheduled visits. Your participation in this study will last approximately 1 year and 5 months consisting of the following: Screening (2 visits); Treatment will be administered (by injection) every 2 weeks for 52 weeks; and safety follow-up (16 weeks).

Institution
MUSC
Recruitment Contact
Traeannah Chisolm
843-792-4296
chisoltr@musc.edu

Utilizing patient navigators to address barriers to care related to access to preventive and specialty healthcare, medication adherence, and health literacy in SLE for minority patients.

Date Added
April 6th, 2020
PRO Number
Pro00095036
Researcher
James Oates

List of Studies


Keywords
Lupus
Summary

To address the health disparities in SLE outcomes for minorities, targeted intervention will be used to address the common barriers to care among patients; a comprehensive patient navigator approach will be utilized based on evidence from prior studies is the purpose of this research. The navigator services most commonly provided include facilitation/coordination of care, practical support, including scheduling transportation and referrals to financial assistance programs, appointment scheduling and reminders, education and psycho-social support. The most effective patient navigators address both health system and patient barriers. Participation in the study will take 5 visits over a period of 12 months.

Institution
MUSC
Recruitment Contact
Gary Link
843-792-7319
linkg@musc.edu



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