LUPUS STUDIES

 

Anti-Ro Antibodies and conduction defects in Adult patients with SLE:
     
The purpose of this study is to test whether irregular heart rhythms are related with inflammation in the heart muscle (myocarditis) and/or heart blood vessel wall failure (endothelial dysfunction) in adults with Lupus.
This study will test the following:

 

1. The association of irregular heart rhythms with the presence of inflammation of the heart muscle (myocarditis) and/or endothelial dysfunction (blood vessel cell wall failure)in SLE adults without  CVD, looking at the presence or not of the protein anti-Ro antibody.

 

2. The relationships of Lupus-specific characteristics with the presence of inflammation of the heart muscle (myocarditis) and/or blood vessel cell wall failure (endothelial dysfunction).

 

The detection of irregular heart rhythms in association with cardiac inflammation and/or blood vessel cell wall failure (endothelial dysfunction) would be of important value as early actions could lead to the prevention of vascular events and survival improvement in patients with SLE.

 

A Randomized, Double-Blind Placebo-Controlled 52-Week Study to
Assess Adverse Events of Special Interest in Adults with Active,
Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab


The purpose of this study is to better understand the side effects of belimumab when given with other lupus medicines. This study mainly focuses on serious side effects that are not that common or may only be seen with long-term treatment. These effects include serious infections, cancers, and serious mental health problems, including depression and suicide. Some of these side effects may cause death. These types of events are more common in patients with lupus than patients without lupus, and these serious side effects have happened in patients receiving belimumab. This study is being done to help understand if treatment with belimumab increases the risk for these types of side effects. This study will also see if patients receiving belimumab with other lupus medicines can reduce their use of steroids (prednisone) over 1 year.


The drug used in this study is called belimumab. Belimumab is a prescription medicine which is in a group of medicines called monoclonal antibodies. People with active lupus often have high levels of a certain protein (called BLyS) in their blood. This protein helps B cells to live longer. Belimumab binds to and limits the activity of this protein and reduces the number of B cells in the blood. When given together with other medicines for lupus, belimumab decreases lupus disease activity more than other lupus medicines alone.


Cardiac Conduction Defect study:


A cross-sectional study will be done to test the occurrence of cardiac conduction defects in SLE patients compared to age/gender controls. In addition, we will test the association of SLE-specific disease characteristics (i.e.antibodies such as anti-Ro) with the presence of cardiac conduction defects in SLE patients.


A total of 100 SLE patients without clinical CVD who fulfill ACR 1997 criteria for a diagnosis of SLE will be recruited from the Lupus Clinic and Private Rheumatology offices at Columbia University Medical Center (CUMC) to undergo 12-lead-EKG testing as part of the study evaluation. A similar number of age and gender matched patients without known CVD will be recruited from the AIM and OB-Gyn clinics at CUMC to serve as controls. All EKGs will be performed for the purposes of this research study but if abnormalities are identified, a referral for further evaluation and/or management will take place.


Significance of Intrarenal T Cells in SLE Nephritis


The purpose of the study is to define the role of T cells in Lupus Nephritis by describing the degree that the T cells enter the kidney and connect these findings with short- and long-term clinical outcomes indicative of progressive renal disease.


 Approximately two out of three Systemic Lupus Erythematosus (SLE) patients develop inflammation of the kidneys called nephritis. Of these patients, only about half respond to current therapy with remission of this kidney inflammation, while a considerable proportion progress to chronic kidney disease and kidney failure. We wish to find out why chronic kidney disease develops in lupus, in particular to determine if certain cells, called T cells) involved in the immune system play a significant role in the development of chronic kidney injury and how these cells cause the injury.


A Multi-center, Randomized Parallel Group, Placebo-Controlled Double-
Blind Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of
Belimumab, a Human Monoclonal Anti-BLyS Antibody, plus Standard
Therapy in Pediatric Patients with Systemic Lupus Erythematosus (SLE)


A multi-center, randomized parallel group, placebo-controlled double-blind trial to evaluate the safety, efficacy, and pharmacokinetics of belimumab, a human monoclonal anti-Blys antibody, plus standard therapy in pediatric patients with systemic lupus erythematosus (SLE).

Belimumab is a biologic drug given by a healthcare provider through a needle placed in a vein, a process known as intravenous infusion (IV infusion). Belimumab (also known as BENLYSTA ™ has been approved in the United States, Canada, and Europe for the treatment of adults with active SLE who are receiving other lupus medicines. Belimumab has not been studied in children with lupus.


  • The study will consist of three phases:
  •       a 52-week randomized, placebo-controlled, double-blind phase;
  •       a long term open label continuation phase; the long term open label continuation and
          safety follow up periods will continue for at least 5 years and possibly up to 10 years from a
          subject’s initial treatment with belimumab or study agent and,
  •       a long term safety follow up phase
     

Retrospective Data Collection and Characterization of Systemic
      Lupus Erythematosus (SLE) in Patients seen at Columbia
      University

     

This study involves a retrospective review of the medical records of patients with a diagnosis of Systemic Lupus Erythematosus (SLE) seen at Columbia University Medical Center's inpatient and outpatient facilities. We would like to review charts from 1/1/2004 to 12/ 31/2015 during this approval year. Study subjects will be identified through medical records ICD-9 codes (SLE, discoid lupus, lupus nephritis). The diagnosis of SLE will be confirmed based on meeting at least 4 American College of Rheumatology (ACR) 1982 SLE classification criteria. Clinical manifestations, therapeutic regimens, preventive screenings, laboratory, pathology and radiographic data recorded in the electronic medical records will be used for the creation of the database.

 

IFN-K-002 Neovacs Phase IIb: a double-blind, randomized, placebo-controlled, multi-center Phase IIb clinical study to assess the biological and clinical efficacy of IFNa-Kinoid in patients suffering from Systemic Lupus Erythematosus


BI 655064 in LN: a Phase II, double-blind, randomized, placebo-controlled trial evaluating the effect of BI 655064 administered as sub-cutaneous injections, on renal response after one year of treatment, in patients with active lupus nephritis


Nobility Roche Phase II WA2974: a randomized, double-blind, placebo-controlled, multi-center study to evaluate the safety and efficacy of obinutuzumab in patients with ISN/RPS 2003 Class III or IV lupus nephritis


XSEL Xencor XmAb5871-04: a randomized, double-blinded, placebo-controlled study of the effect of XmAb5871 on Systemic Lupus Erythematosus Disease Activity


CALIBRATE ITN055AI: rituximab plus cyclophosphamide followed by belimumab for the treatment of lupus nephritis


EMBRACE: efficacy of belimumab in lupus subjects of black race


NISLE (Nelfinavir in SLE): a study of whether a protease inhibitor, nelfinavir, decreases anti-double stranded DNA antibody binding and SLE disease activity


TULIP: A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus


CNTO1275SLE2001: A Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Study of Ustekinumab (Stelara®) in Subjects With Active Systemic Lupus Erythematosus


STEADY: A Phase II Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-range Finding Study to Evaluate the Safety and Efficacy of ALX-0061 Administered Subcutaneously in Subjects with Moderate to Severe Active Systemic Lupus Erythematosus


TRESTLE: A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability and Pharmacokinetic Study of Multiple Rising Doses of MLN9708 for the Treatment of Subjects With ISN / RPS Class III or IV Lupus Nephritis


CC-220-SLE-001: A Pilot, Phase 2, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Pharmacogenetics of CC-220 in Subjects with Systemic Lupus Erythematosus


ACTHar in the Treatment of Lupus Nephritis: Investigator-initiated, open-label, prospective randomized study to determine the efficacy and safety of two dosing regimens of ACTHar in the treatment of proliferative lupus nephritis


Ajulemic Acid (JBT-101) in SLE with Musculoskeletal Disease: A Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Efficacy, Safety, and Tolerability of JBT-101 in Systemic Lupus Erythematosus


Lupus and Autoimmune Disease Registry: Observational cohort study of patients with autoimmune and rheumatologic conditions designed to study biologic factors contributing to the phenotypes and clinical presentations of these diseases


Malignancy Risk in SLE: Comparison of clinical and pathological features of cancers developing in SLE to those in the general population to determine if SLE disease activity is associated with the development of lymphoma and other cancers


SLICC Registry for Atherosclerosis in SLE (RAS) and Neuropsychiatric-SLE (NP-SLE): An international, multi-center, prospective, inception cohort study of atherosclerosis in lupus and neuropsychiatric systemic lupus erythematosus

Interested in Participating
  • Participating in Research

    If you are interested in participating in any of our research trials, please contact:
    Afshin Zartoshti at az2200@columbia.edu
    Phone: 212-342-2751