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New treatment option for Lupus Erythematosus, Systemic
Official title Trial of Belimumab in Early Lupus
ClinicalTrials.gov ID: NCT03543839
What this study is testing
What is Belimumab?
Belimumab is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for lupus erythematosus, systemic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Manhasset, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Manhasset, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.