Is NCT03543839 recruiting in Manhasset, NY?

Yes, NCT03543839 is currently recruiting participants at its Manhasset, NY location. This lupus erythematosus, systemic clinical trial is actively enrolling qualified participants.

How do I join the lupus erythematosus, systemic clinical trial in Manhasset?

To join this clinical trial in Manhasset, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Manhasset clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Lupus Erythematosus, Systemic Clinical Trial in Manhasset, NY

About This Lupus Erythematosus, Systemic Study in Manhasset

This two year study will evaluate the effects of giving belimumab (Benlysta) to patients with Early Lupus. Early lupus is a diagnosis of lupus within 2 years. Subjects will be randomized to receive belimumab or placebo during the first year. During the second year, subjects who were randomized to belimumab will be rerandomized to continue to receive belimumab or to receive placebo. The study will look at clinical effects as well as effects on the immune system.

Sponsor: Northwell Health

Who Can Participate

Inclusion Criteria

Diagnosis of SLE per current ACR classification criteria

Date of SLE diagnosis within 2 years of screening

ANA positive (with a titer ≥ 80)

anti-ds DNA antibody positive

Mild to moderate disease activity define by a SLEDAI-2K ≥4

Stable corticosteroid dose in the 4 weeks prior to screening ≤ 30mg/day.

If on methotrexate, dose must be stable for 4 weeks

Concomitant treatment with hydroxychloroquine unless documented inability to tolerate

Able and willing to give written informed consent and comply with the requirements of the study protocol

Negative serum pregnancy test (for women of child bearing potential)

Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for 16 weeks after completion of treatment

Exclusion Criteria

Previous exposure to disease modifying drugs such as azathioprine, mycophenolate mofetil, cyclophosphamide, or cyclosporine.

Previous exposure to biologic therapies including rituximab, belimumab or other agents that have been investigated for SLE.

Active renal or nervous system disease or disease activity fulfilling BILAG A criteria

Use of high dose steroids (\>0.5 mg/kg/ day) within the 4 weeks prior to screening

Expectation (by the investigator) that the subject will require treatment with a disease modifying drug within the first 52 weeks of the study

Hemoglobin: \< 8.0 gm/dL

Platelets: \< 50,000/mm

ANC \< 1.0 x 103/mm

AST or ALT \>2.5 x Upper Limit of Normal unless related to primary disease.

Creatinine clearance ≤ 25ml/min per 1.73 m2

Positive Hepatitis B or C serology (Hep B Surface antigen, Hep B core Ab or Hepatitis C antibody)

History of positive HIV (HIV conducted during screening if applicable)

Treatment with any investigational agent within 4 weeks of screening or 5 half-lives of the investigational drug (whichever is longer)

Receipt of a live vaccine within 30 days prior to baseline or concurrently with belimumab

Have a history of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins or monoclonal antibodies

Currently on any suppressive therapy for a chronic infection (such as tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical mycobacteria)

Hospitalization for treatment of infection within 60 days of Day 0.

Use of parenteral (IV or IM) antibiotics (antibacterials, antivirals, anti-fungals, or anti parasitic agents) within 60 days of Day 0

History of serious recurrent or chronic infection

Lack of peripheral venous access

History of drug, alcohol, or chemical abuse within 365 days prior to Day 0

Pregnancy (a negative serum pregnancy test must be obtained for all women of childbearing potential at screening; a urine pregnancy test must be negative \< 7 days prior to first dose and monthly)

History of psychiatric disorder that would interfere with normal participation in this protocol

Significant cardiac or pulmonary disease (including obstructive pulmonary disease)

Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications

History of malignant neoplasm within the last 5 years with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix

Evidence of serious suicide risk including any history of suicidal behaviour in the last 6 months and/or any suicidal ideation in the last 2 months or who in the investigator's judgment, pose a significant suicide risk

History of a primary immunodeficiency

Have a significant IgG deficiency (IgG level \< 400 mg/dL)

Have an IgA deficiency (IgA level \< 10 mg/dL)

Have any other clinically significant abnormal laboratory value in the opinion of the investigator

Comorbidities requiring corticosteroid therapy, including those which have required two or more courses of systemic courses of systemic corticosteroids within the previous 12 months

Inability to comply with study and follow-up procedures

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Manhasset?

Yes, this clinical trial (NCT03543839) has an active research site in Manhasset, NY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Lupus Erythematosus, Systemic Treatment Options in Manhasset, NY

If you're searching for lupus erythematosus, systemic treatment options in Manhasset, NY, this clinical trial (NCT03543839) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Manhasset research site is actively enrolling participants for this clinical trial. You'll receive care from experienced lupus erythematosus, systemic specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all lupus erythematosus, systemic clinical trials near you to find additional studies recruiting in your area.

Lupus Erythematosus, Systemic Clinical Trial in Manhasset, NY

Expert Care in Manhasset

IRB Approved

No-Cost Care

Apply for This Manhasset Location

Why Participate?

Simple Process