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Benralizumab vs Mepolizumab for Vasculitis (MANDARA Trial)
MANDARA Trial Summary
This trial is testing a new drug, benralizumab, to see if it is more effective and has fewer side effects than the current standard of care drug, mepolizumab, for people with a certain type of blood cancer who have not responded well to other treatments.
MANDARA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowMANDARA 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 2016 Phase 3 trial • 220 Patients • NCT02075255MANDARA Trial Design
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Who is running the clinical trial?
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- I have or had cancer within the specified timeframes.My EGPA has returned or didn't respond to treatment recently.My dose of immunosuppressive medication has been stable.I am on long-term medication for an infection.My liver condition is not stable.I have not had a severe EGPA flare-up in the last 3 months.I have been on a stable dose of prednisolone or prednisone for at least 4 weeks.I have had a worm infection that was either not treated or did not respond to treatment in the last 6 months.I do not have any other illnesses that could affect my safety or the study results.I have been diagnosed with EGPA, including asthma and high eosinophils.Your heart's electrical activity is within a certain range.I have been diagnosed with GPA or MPA.I am 18 years old or older.I have severe heart problems that are not under control.You have a condition that weakens your immune system or have tested positive for HIV.I have not taken certain medications recently.
- Group 1: Benralizumab arm
- Group 2: Mepolizumab arm
- 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
Does this test have an age limit?
"This trial is meant for patients that are 18-130 years old. For patients outside of this age bracket, there are other clinical trials; 13 for those under 18 and 72 for seniors above 65."
How many individuals are participating in this research project?
"Presently, this trial is not looking for any more participants. The clinical trial was first posted on 11/5/2019 and edited for the last time on 9/1/2022. However, there are 40 other trials actively recruiting patients with eosinophilic granulomatous vasculitis and 35 trials involving Benralizumab that are still enrolling patients."
What is the current standing of Benralizumab in the United States?
"Benralizumab is safe according to our Power team's estimation. This estimate comes from the fact that this medication is in Phase 3 of clinical trials."
For what ailments is Benralizumab commonly prescribed?
"Benralizumab is a medication used to treat hypereosinophilic syndrome, but it can also be given to patients with other conditions like polyangiitis or corticosteroid therapy."
Are new participants being taken in for this experiment?
"Unfortunately, this particular clinical trial is not seeking new candidates at the moment. The listing on clinicaltrials.gov shows that the study was initially posted on November 5th, 2019 and was last updated September 1st, 2020. With that being said, there are 75 other trials currently looking for participants which can be found on our website."
Is this a new clinical trial?
"First studied in 2014, Benralizumab rapidly received Phase 2 & 3 drug approval after initial clinical testing. Today, there are 35 different ongoing trials for this medication being conducted in 455 cities and 42 countries."
Do you have any information about other research studies that have used Benralizumab?
"35 clinical trials are underway to research Benralizumab. Of these, 17 have reached Phase 3 and are ongoing. Most of the trial sites for this medication are based in Hamilton, Ontario; however, there are 1865 total locations running studies related to this treatment across the world."
Are there several locations where this study is being conducted within the United States?
"To make the trial more accessible to a wider range of patients, 29 sites have been selected. These are in Calgary, Boston, Columbus and 26 other locations. If you enroll in the study, it is best to choose the site nearest you so that you will not need to travel as much."
If I enroll in the study, am I able to see its benefits for myself?
"This trial is looking for 140 patients that have eosinophilic granulomatous vasculitis and are between 18 and 130 years old. Applicants must meet the following criteria: a history of relapsing EGPA (defined as at least one confirmed relapse within the last two years), refractory EGPA (failure to achieve remission after treatment with standard induction therapy for at least three months), or recurrence of symptoms when tapering off oral corticosteroids. Additionally, applicants must be on a stable dose of oral prednisolone or prednisone of at least 7.5 mg/"
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