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Belimumab for Lupus
Study Summary
This trial is studying the effects of belimumab on pediatric patients with lupus.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2018 Phase 3 trial • 80 Patients • NCT02119156Trial Design
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Who is running the clinical trial?
Media Library
- I have severe kidney inflammation that might need treatment in the first 12 weeks of the trial.I am on medication for a long-term infection like TB or herpes.I've needed 3 or more steroid treatments for another condition in the last 3 months.I am taking or have taken Abatacept.I have tested positive for Hepatitis B.My liver enzyme levels are stable and not due to alcohol, uncontrolled diabetes, or viral hepatitis.I meet at least 4 of the criteria for lupus.I am either male or female.I do not have any major health issues unrelated to my lupus that could risk my safety in the study.I have been on a consistent lupus treatment for at least 30 days.I have not been treated with medications targeting B-cells.I am receiving IVIG treatment.I have a health condition that may not make me suitable for this study, according to a doctor.My blood tests show positive for specific autoantibodies.I have a severe lab result that's not on the allowed list.I am taking anakinra for my condition.My blood tests show positive for specific autoantibodies.I have undergone plasmapheresis.I am not pregnant or breastfeeding and either cannot become pregnant or am using effective birth control.I haven't taken any IV or IM antibiotics for infections in the last 60 days.I haven't had certain treatments in the last 90 days.I haven't taken any experimental drugs recently.I am not taking any new immune system altering drugs.I have lupus affecting my brain or nerves and needed treatment for it within the last 2 months.I have stable low white blood cell counts due to lupus.I am currently taking or have taken anti-TNF medication.I am not taking high doses of steroids or receiving them by injection.I tested positive for Hepatitis C antibody but negative for the virus itself.You have been diagnosed with systemic lupus erythematosus (SLE) using the 1997 American College of Rheumatology criteria.My blood clotting time is stable due to my warfarin treatment.I am managing an ongoing infection.I have protein in my urine.I am not currently taking any NSAIDs.I have stable low blood protein levels due to kidney issues from lupus, not because of liver disease or poor nutrition.My blood takes longer to clot due to lupus, not liver disease or medication.My lupus is active with a SELENA SLEDAI score of 6 or more.I have been on a consistent lupus treatment for at least 30 days.You have tried to harm yourself in the past 6 months or are at high risk of hurting yourself, according to the investigator.I am taking a low dose of steroids, not exceeding 0.5 mg/kg/day.I have been treated with belimumab before.I am not currently taking NSAIDs.I have had cancer in the past 5 years.I have not received a live vaccine in the last 30 days.I am not taking anti-malarial medications like hydroxychloroquine.I cannot self-administer the injection and do not have anyone to do it for me.I am between 5 and 17 years old.I haven't started a new lupus treatment in the last 30 days.My kidney function, measured by eGFR, is below 30 mL/min.I have had a major organ or stem cell transplant.I haven't had certain treatments in the last 364 days.I haven't had certain treatments in the last 30 days.I am receiving or have received IV cyclophosphamide.I have been on dialysis or needed it in the last 90 days.I have not taken any experimental drugs.You have a current drug or alcohol addiction or have had an addiction within the past year.You cannot participate in another experimental treatment study at the same time or within 6 months before starting this study. However, you may be allowed to participate in an observation-only study.I am not currently taking any immune system altering drugs.
- Group 1: Belimumab 200 mg
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Has the U.S. Food and Drug Administration certified Belimumab?
"Belimumab is deemed safe, evidenced by its rating of 2; this reflects the fact that there exists some evidence confirming safety but none substantiating efficacy."
What former research has focused on Belimumab?
"Currently, 17 medical studies are underway to evaluate Belimumab. Out of these, two have reached Phase 3 and they span a total of 88 trial sites worldwide with many situated in Beijing."
What is the major aim of this experimentation?
"According to the study sponsor, GlaxoSmithKline, the primary outcome being measured over a 12-week period is Cmin of Belimumab at steady state. The secondary outcomes include changes from baseline in IgG and IgM immunoglobulin levels as well as number of adverse events experienced by participants."
Who is eligible to participate in this medical research?
"This clinical trial aims to examine 30 participants between the ages of five and seventeen, all with systemic lupus erythematosus. To be eligible for enrolment, patients have to meet several criteria: they should lie within the stipulated age range on Day 1; fulfill at least four American College of Rheumatology (ACR) 1997 criteria in series; present an active SLE disease as demonstrated by a Safety of Estrogen in Lupus Erythematosus National Assessment (SELENA)-Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score ≥ 6 during"
What is the total number of participants currently enrolled in this trial?
"This research endeavour is no longer recruiting participants. Initially posted on the 28th of November 2019 and last updated on April 8th 2022, any potential patients are encouraged to investigate other trials for lupus erythematosus systemic with 124 studies enrolling or Belimumab related trials with 17 actively seeking volunteers."
Is this study a pioneering endeavor?
"Belimumab has been the target of research since 2012, when it was initially studied by Human Genome Sciences Inc., a GSK Company. After securing Phase 2 drug approval following its first trial in 2012 with 93 participants, Belimumab is now being examined across 36 cities and 15 countries via 17 live studies."
Are those younger than 55 years of age able to partake in this research?
"The conditions of this clinical trial dictate that suitable recruits must be between 5 and 17 years old. In total, 21 trials are accommodating minors while 120 studies have senior citizens as their target demographic."
Are there still opportunities to participate in this experiment?
"According to the clinicaltrials.gov webpage, this particular medical trial is not presently recruiting patients; its initial posting was on November 28th 2019 and it last edited on April 8th 2022. Although there are no longer spots available for this study, 141 other studies in progress are actively accepting participants as of now."
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