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Emapalumab for MAS in Still's Disease or Lupus (EMERALD Trial)
EMERALD Trial Summary
This trial is testing a new drug to see if it's safe and effective for treating macrophage activation syndrome (sHLH/MAS) in people with Still's disease or systemic lupus erythematosus.
EMERALD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowEMERALD Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2021 Phase 2 & 3 trial • 58 Patients • NCT02069899EMERALD Trial Design
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Who is running the clinical trial?
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- I am willing to use effective birth control from the start of the study until 6 months after the last dose.My cancer diagnosis has been confirmed.I am not taking canakinumab, JAK inhibitors, TNF inhibitors, or tocilizumab when starting emapalumab.I have been diagnosed with a leishmania infection.I am between 6 months and 80 years old and have been diagnosed with MAS.I have been treated with etoposide for MAS within the last month.I have MAS and need treatment with steroids.I have not received a live vaccine in the last 4 weeks.I have been diagnosed with lupus according to the SLICC'12 criteria.I have been diagnosed with systemic Juvenile Idiopathic Arthritis (sJIA).I have a genetic form of HLH or a family history of it.I do not have active infections like TB, histoplasmosis, or salmonella.I have not improved after receiving high-dose steroid treatments for at least 3 days.I have received a BCG vaccine in the last 12 weeks.I am currently taking more than 4 mg/kg of anakinra.My rheumatologist confirmed I have active MAS.
- Group 1: Cohort 1 (sJIA and AOSD) and Cohort 2 (SLE)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
Is this the first time researchers have looked into Emapalumab?
"Emapalumab was first researched at Osaka Medical and Pharmaceutical University Hospital in the year 2021. Since then, there have been 5 completed studies with 1 ongoing clinical trial. The majority of the research being conducted surrounding emapalumab is happening in Montréal, Florida."
Is this study innovative in any way?
"Emapalumab, which is being trialed by 9 cities across 11 countries, is currently in its first year of testing. The first study occurred in 2021 and was sponsored by Swedish Orphan Biovitrum. 41 patients completed Phase 3 of the trial and it is now awaiting drug approval. 5 trials have been conducted in total since 2021."
Are doctors and clinics still enrolling patients in this trial?
"That is correct, according to the latest information on clinicaltrials.gov, this trial is still looking for patients. The listing was put up on December 15th, 2021 and was updated most recently on October 31st, 2022. In total, the study needs 41 people at 14 different sites."
Has Emapalumab been cleared by the FDA?
"Emapalumab's safety is well-documented, as it has reached Phase 3 in clinical trials."
Does this medical research allow for adults under the age of 35?
"The required age range for participation in this trial is between 6 months and 80 years old."
What type of patient is eligible for this research project?
"The current study is investigating a potential treatment for macrophage activation syndrome. In order to qualify, patients must be between 6 months and 80 years old. Up to 41 people will be accepted into the trial."
Is this trial widely available in urban areas?
"Presently, there are 14 sites enrolling patients for this research. If you reside near Montréal, Gainesville, or Philadelphia, you may have the opportunity to participate in this study without having to travel far. However, if you do not live near these cities, there are still 11 other potential locations for you to consider."
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