Trial of Belimumab in Early Lupus
Pilot Trial of Belimumab in Early Lupus
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This 2-year study tests belimumab (Benlysta) in people diagnosed with lupus within the past 2 years. It compares the drug with a placebo, a treatment with no active drug. Researchers will study its effects on lupus and the immune system, which helps the body fight infections.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have systemic lupus erythematosus (SLE) that meets accepted diagnosis rules, diagnosed within 2 years before screening.
- Have positive lupus blood tests: ANA at a level of at least 80 and anti-dsDNA antibodies.
- Have mild to moderate lupus activity, with a disease activity score called SLEDAI-2K of at least 4.
- Have a stable steroid dose of no more than 30 mg a day for 4 weeks before screening.
- If taking methotrexate, have a stable dose for 4 weeks.
- Take hydroxychloroquine unless there is a documented reason you cannot tolerate it.
- Be able and willing to give written consent and follow study rules.
- If able to become pregnant, have a negative pregnancy blood test. Men and women able to have children must use accepted birth control during treatment and for 16 weeks afterward.
Who can't join
- Past use of drugs such as azathioprine, mycophenolate, cyclophosphamide, or cyclosporine; past biologic treatments such as rituximab or belimumab; or expected need for a disease-modifying drug in the first year.
- Active kidney or nervous system disease, severe lupus activity, major heart or lung disease, or another condition that makes treatment unsafe or affects study results.
- Blood counts below study limits, very poor kidney function, high liver test results unless due to lupus, low immune proteins, an inherited immune system problem, or other important abnormal lab results.
- Positive hepatitis B or C tests, a history of HIV, serious repeated or long-term infections, ongoing treatment to control a chronic infection, or hospital care or injected medicines for infection within 60 days before the study starts.
- High-dose steroids within 4 weeks before screening; another condition requiring steroids; recent experimental treatment; or a live vaccine within 30 days before the study starts or during belimumab treatment.
- A past life-threatening allergic reaction to injected contrast dye, human or mouse proteins, or antibody medicines; no usable vein for treatment; or cancer within 5 years, except certain adequately treated skin or early cervical cancers.
- Pregnant or breastfeeding; drug, alcohol, or chemical abuse within the past year; a mental health condition that prevents participation; or serious suicide risk, including suicidal behavior within 6 months or suicidal thoughts within 2 months.
- Unable to follow study visits and follow-up procedures.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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) * Lactation * 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
Study sites (1)
NY
- Feinstein Institute · Manhasset, NY 11030Sanita Kandasami · Study contact · 516-562-2401 · skandasami@northwell.eduCynthia Aranow, M.D. · Principal investigatorMore trials in Manhasset