Study of Mepolizumab-based Regimen Compared to Conventional Therapeutic Strategy in Patients With… (NCT05030155) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Study of Mepolizumab-based Regimen Compared to Conventional Therapeutic Strategy in Patients With Eosinophilic Granulomatosis With Polyangiitis (E-merge)
France100 participantsStarted 2022-05-30
Plain-language summary
The purpose of this study is to compare mepolizumab-based regimen to conventional therapeutic strategy for remission induction in patients with Eosinophilic Granulomatosis with Polyangiitis.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with a diagnosis of EGPA independently of ANCA status,
* Patients aged of 18 years or older,
* Patients with newly-diagnosed disease or relapsing disease at the time of screening, with an active disease defined as a Birmingham Vasculitis Activity Score (BVAS) ≥3,
* Patients within the first 21 days following initiation/increase of corticosteroids at a dose ≤ 1 mg/kg/day (pulses of methylprednisolone before oral corticosteroid therapy are authorized)
* Patients having given their written informed consent prior to participation in the study.
* Patients affiliated with social security or CMU (profit or being entitled)
Exclusion Criteria:
* Patients with GPA, MPA, or other vasculitis, defined by the ACR criteria and/or the Chapel Hill Consensus Conference,
* Patients with vasculitis in remission of the disease defined as a BVAS \<3
* Patients with severe cardiac failure defined as class IV in New York Heart Association
* Patients with acute infections or chronic active infections (including HIV, HBV or HCV and checked in the last 12 months),
* Patients with active cancer or recent cancer (\<5 years), except basocellular carcinoma and prostatic cancer of low activity controlled by hormonal treatment,
* Pregnant women and lactation. Patients with childbearing potential should have reliable contraception for the 12 months duration of the study,
* Patients with EGPA who have already been treated with mepolizumab within the previous 12 months,
* Patie…
What they're measuring
1
Percentage of patients who achieved a prednisone dose of 4.0 mg or less per day at day 168, without experiencing a relapse