Overview

Principal Investigator

Sarfaraz Hasni, M.D.

Dr. Sarfaraz Hasni’s is interested in clinical research to improve lives of patients with lupus through discovery of biomarkers and conducting clinical trials using novel agents.

Current management of patients with SLE is usually stratified by the degree of internal organ involvement; treatment strategies include a variety of immunosuppressive medications used alone or in combination that are limited both in their efficacy and by significant potential toxicities. Clearly there is an unmet need for improved treatment of inflammation in this patient population.  The all-cause mortality in SLE has greatly improved but there is significant morbidity and increased mortality due to accelerated atherosclerotic vascular disease. Further, premature cardiovascular disease risk may be as high as 50-fold when compared to matched controls and is not explained by the traditional risk factors. The underlying pathogenic mechanisms involved in endothelial dysfunction leading to premature atherosclerosis in lupus remain elusive.  Advances in immunosuppression and close monitoring of patients have decreased organ damage in lupus, but no drug to this date has proven to abrogate atherosclerosis development in SLE.  Identifying a drug that has immunomodulatory effects and is also vasculo-protective is an unmet need in this disease.

The Lupus Clinical Research Program at NIAMS conducts innovative translational and clinical research into the causes, treatment, and prevention of SLE. The Lupus Clinical Research Program maintains a comprehensive clinical data base of SLE patients that includes patient demographics, SLE disease activity and damage indices, patient reported outcome tools, and other data for phenotyping our cohort. The SLE Natural History and Pathogenesis protocol serves as a pivotal resource for understanding and characterizing the heterogeneity of this disease, providing biological specimens and outstanding clinical phenotyping to various intramural and extramural labs involved in lupus research.  This collaborative research model has led to several biomarker discoveries and scientific hypothesis generation. These discoveries have been translated into clinical trials by the Lupus Clinical Trials Unit.

The Lupus Clinical Research Program has established The DC Lupus Consortium(DCLC), a collaborative network of rheumatologists, nephrologists, physiatrists and other health care providers interested in lupus clinical research in the Metropolitan DC area. The purpose of the DCLC is to promote partnerships and referrals to the NIAMS Lupus Clinical Research Program and collaborations with local and regional clinicians caring for patients with lupus.

The Lupus Clinical Trials Unit (LCTU) of the Lupus Clinical Research Program develops and implements clinical research protocols and conducts high impact, innovative clinical research based largely on the discoveries resulting from NIAMS IRP translational research.

Current projects:

  • Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Systemic Lupus Erythematosus; a Phase Ib Clinical Trial and Associated Mechanistic Studies
  • The Role of PPAR-gamma Agonists in immunomodulation and Vascular Prevention in SLE (PPAR-SLE)
  • Natural history of vascular damage and atherosclerosis development in SLE
  • Deep immuno-phenotyping and systematic study of serum proteins and gene expression in SLE
  • Aerobic Exercise in Women with Systemic Lupus Erythematosus (Exercise SLE)

Studies Seeking Patients:

  1. Role of PPAR-y Agonists in Immunomodulation and Vascular Prevention in SLE (PPAR-SLE): We propose that TZDs such as pioglitazone could significantly improve blood vessel function and play a role in atherosclerosis prevention in human SLE, in addition to modifying lupus disease activity.  The major goal of the proposed research is to assess the effects of the PPAR-γ agonist pioglitazone in SLE on vascular function and inflammation and on SLE disease activity. The results of the study may lead to the characterization of a new therapeutic target with dual effects on lupus and its associated blood vessel damage.
    ClinicalTrials.gov identifier: NCT02338999
  2. Vascular Study of Lupus patients: Patients with Lupus have an increased risk of developing heart attacks and stroke due to hardening of the arteries (atherosclerosis). By examining how your blood vessels function and whether they are damaged and by comparing these tests to those of patients without Lupus, we will be able to better understand what triggers this complication in lupus and hopefully identify potential strategies to prevent this damage.
    ClinicalTrials.gov identifier: NCT00001372
  3. Aerobic Exercise in Women with Systemic Lupus Erythematosus: With this study, investigators are interested in exploring the effect of aerobic exercise (running on a treadmill) on lupus activity and its biomarkers, in women.  The study lasts for 12 weeks and requires 3 exercise visits per week.  This trial is open to women with mild to minimal lupus activity who report high levels of fatigue, or feel that fatigue is one of the primary manifestations of their lupus.
    ClinicalTrials.gov Identifier: NCT03186794
  4. Natural History of SLE: It’s a study that follows a group of people over time who have SLE. The goals of this study are:
    ClinicalTrials.gov identifier: NCT00001372
    • Most importantly to do various research studies to find out what causes SLE and develop new and better treatment for Lupus patients.
    • To follow patients during the course of the disease to understand how the disease changes over time and the effects of standard treatments.
    • To evaluate patients thought to have the disease to better understand how the disease begins and how it affects patients.

Staff

Senior Investigator and Chief
Acting Director
Nurse Practitioner
Nurse Practitioner
301-496-4644
Henry Metzger Scholar in Translational Medicine
301-443-8541
Director, Lupus Clinical Research Program
301-451-1599
Clinical Data Analyst
301-827-0546
Patient Care Coordinator
301-451-4650
Clinical Research Nurse Specialist
301-435-4489
Clinical Research Nurse Specialist
301-451-4990

Studies Seeking Patients

  1. Role of PPAR-y Agonists in Immunomodulation and Vascular Prevention in SLE (PPAR-SLE): We propose that TZDs such as pioglitazone could significantly improve blood vessel function and play a role in atherosclerosis prevention in human SLE, in addition to modifying lupus disease activity.  The major goal of the proposed research is to assess the effects of the PPAR-γ agonist pioglitazone in SLE on vascular function and inflammation and on SLE disease activity. The results of the study may lead to the characterization of a new therapeutic target with dual effects on lupus and its associated blood vessel damage.
    ClinicalTrials.gov identifier: NCT02338999
  2. Vascular Study of Lupus patients: Patients with Lupus have an increased risk of developing heart attacks and stroke due to hardening of the arteries (atherosclerosis). By examining how your blood vessels function and whether they are damaged and by comparing these tests to those of patients without Lupus, we will be able to better understand what triggers this complication in lupus and hopefully identify potential strategies to prevent this damage.
    ClinicalTrials.gov identifier: NCT00001372
  3. Aerobic Exercise in Women with Systemic Lupus Erythematosus: With this study, investigators are interested in exploring the effect of aerobic exercise (running on a treadmill) on lupus activity and its biomarkers, in women.  The study lasts for 12 weeks and requires 3 exercise visits per week.  This trial is open to women with mild to minimal lupus activity who report high levels of fatigue, or feel that fatigue is one of the primary manifestations of their lupus.
    ClinicalTrials.gov identifier: NCT03186794
  4. Natural History of SLE: It’s a study that follows a group of people over time who have SLE. The goals of this study are:
    ClinicalTrials.gov identifier: NCT00001372
    • Most importantly to do various research studies to find out what causes SLE and develop new and better treatment for Lupus patients.
    • To follow patients during the course of the disease to understand how the disease changes over time and the effects of standard treatments.
    • To evaluate patients thought to have the disease to better understand how the disease begins and how it affects patients.
Last Reviewed: 08/10/2017