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Belimumab for Pediatric Lupus (PLUTO Trial)
PLUTO Trial Summary
This trial is testing a new drug for lupus in kids. They want to see if it's safe and works well.
PLUTO Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPLUTO Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.PLUTO Trial Design
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Who is running the clinical trial?
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- I am scheduled for surgery.I have not had cancer in the last 5 years.I haven't had B cell therapy or experimental treatments in the last year.I have received treatments like anti-TNF, IVIG, or plasmapheresis in the last 90 days.I, or my child, have agreed to participate and a parent or guardian has given consent.I have taken high doses of prednisone or a similar medication in the last 60 days.I haven't taken any new immune or anti-malarial drugs in the last 60 days.I do not have any major health issues unrelated to my lupus.I am willing to use birth control.I have severe kidney disease due to lupus.I have been on a steady lupus treatment for at least 30 days.I have been diagnosed with lupus according to ACR criteria.I have been treated for an infection in the last 2 months.You have had a severe allergic reaction to X-ray contrast agents or biologic agents.I have an IgA deficiency.My lupus is currently active and severe.I have lupus affecting my brain or spinal cord.I have had a major organ transplant.You have a history of thoughts about hurting yourself or have tried to hurt yourself in the past.You currently have a problem with using drugs or alcohol too much.I am between 5 and 17 years old.I have been treated with belimumab (BENLYSTA®) before.I have received IV cyclophosphamide within the last 60 days.
- Group 1: Arm 2
- Group 2: Arm 1
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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
Are there age restrictions for joining this experiment?
"This clinical trial is only available to individuals aged between 5 and 17. By comparison, there are 21 other trials targeting minors while 120 focus on seniors over 65 years of age."
Is recruitment still active for this clinical exploration?
"According to the information posted on clinicaltrials.gov, this research is no longer enlisting subjects. Initially made available in September 2012 and last edited November 2022, 141 other studies are actively recruiting patients at present time."
What potential risks may be associated with a 10mg/kg dose of belimumab?
"Belimumab 10mg/kg received a score of 2 on our safety scale, considering it is currently undergoing phase 2 trials and there has been some evidence to substantiate its security but no studies have explored if it works."
Am I an acceptable participant to join this investigation?
"This trial is seeking 93 individuals who have libman-sacks disease and are within the age boundaries of 5 to 17. Qualified participants can apply for this study."
Is this research the inaugural investigation of its kind?
"Since 2012, the drug belimumab 10mg/kg has been explored in a variety of clinical trials. The first trial was conducted by Human Genome Sciences Inc., and resulted in Phase 2 approval for the medication. Currently, there are 17 active studies on this medicine being carried out across 15 countries with 36 different cities involved as well."
How many sites are undertaking this experiment?
"Currently, 9 medical centres are running this clinical trial. Locations include Calgary, Augusta and Cincinnati as well as a number of other sites. To limit travel needs during the experiment, it is suggested that participants select the closest centre."
What previous experiments have studied the impacts of 10mg/kg belimumab?
"Currently, there are 17 clinical trials for belimumab 10mg/kg in progress. Of those, two have entered Phase 3 of the trial process. The majority of these studies take place in Beijing; however, 88 sites across the globe offer this treatment to participants."
What is the upper limit on participants in this trial?
"This medical trial is no longer accepting applicants. It was initially published on September 7th 2012 and last updated November 15th 2022. Should you be searching for other options, there are presently 124 trials searching for participants with Libman-Sacks disease and 17 trials actively recruiting patients receiving 10mg/kg Belimumab dosages."
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