CardiolRx in Recurrent Pericarditis Following IL-1 Blocker Cessation (MAVERIC)
Status: Not yet recruiting
Conditions: Pericarditis
Location:
Cleveland ClinicMassachusetts General Hospital
Mayo Clinic in Rochester
Northwestern University Medicine
University of Virginia
City/State:
Chicago, Illinois
Boston, Massachusetts
Rochester, Minnesota
Cleveland, Ohio
Charlottesville, Virginia
Contact Information:
Name: Andrea B Parker, MSc., PhD
Phone Number: +1 289 910 0862
Email: [email protected]
Name: Heather Dalgleish, MSc.
Phone Number:+1 289 910 0384
Email: [email protected]
Double-blind treatment will be initiated 10 – 14 days prior to the last scheduled dose of the IL-1 blocker and continued for 24 weeks.
The objective is to assess whether patients who discontinue therapy with an IL-1 blocker for recurrent pericarditis remain free of pericarditis recurrence while receiving CardiolRx.
After informed consent is obtained, patients will be screened for eligibility. Baseline assessments will be performed during screening within 7 days of Day 1 (Visit 1) and include the following: Physical examination, vital signs, highest NRS pain score within the past 7 days of Day 1, 12-lead ECG; hematology (CBC with differential) and blood chemistry (including complete metabolic panel: sodium, potassium, calcium, glucose, ALT/AST, bilirubin, alkaline phosphatase, blood urea nitrogen (BUN), creatinine/eGFR), C-SSRS and a pregnancy test for women of childbearing potential.
Eligible patients will be randomized on Day 1 to either CardiolRx or matching placebo. Double-blind trial therapy will be initiated in the evening of Day 1, 10 – 14 days prior to the last scheduled dose of the IL-1 blocker and after all baseline assessments are completed. Trial therapy will be administered for 24 weeks.
Final efficacy assessments will take place 24 weeks after starting trial therapy and include a physical exam, vital signs, pain score NRS, a 12-lead ECG, as well as laboratory assessments (including a pregnancy test in women of childbearing potential) and a C-SSRS.
A safety follow-up visit will be scheduled 4 weeks after the last trial therapy administration.