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NCT05137496 | Not yet recruiting | Macrophage Activation Syndrome

Ruxolitinib and Methylprednisolone as a First-line Treatment for Macrophage Activation Syndrome
Sponsor:

Beijing Friendship Hospital

Information provided by (Responsible Party):

Zhao Wang

Brief Summary:

The present study was a single-center, prospective, non-comparative in which macrophage activation syndrome patients were selected as the main subjects to evaluate the effect and safety of Ruxolitinib and methylprednisolone regimens as the first-line therapy .

Condition or disease

Macrophage Activation Syndrome

Intervention/treatment

Ruxolitinib

methylprednisolone

Phase

Phase 3

Study Type : Interventional
Estimated Enrollment : 40 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : A Single-center, Prospective, Non-comparative Clinical Trial of Ruxolitinib and Methylprednisolone as a First-line Treatment for Macrophage Activation Syndrome
Actual Study Start Date : June 1, 2022
Estimated Primary Completion Date : June 1, 2023
Estimated Study Completion Date : June 1, 2024
Arm Intervention/treatment

Experimental: Ruxolitinib+methylprednisolone

Ruxolitinib and methylprednisolone administered as the first-line therapy

Drug: Ruxolitinib

Drug: methylprednisolone
Ages Eligible for Study: 1 Year to 75 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • Meet hemophagocytic lymphohistiocytosis (HLH)-04 diagnostic criteria; patients were diagnosed with autoimmune disease associated HLH (Macrophage activation syndrome, MAS).
  • No HLH induction therapy was performed.
  • The expected survival time is more than 1 month.
  • Serum creatinine ≤ 1.5 times normal；Serum human immunodeficiency virus(HIV) antigen or antibody negative； Hepatitis C virus (HCV) antibody is negative, or HCV antibody is positive, but HCV RNA is negative；HBV copies less than 1E+03 copies/ml.
  • Total bilirubin ≤10 times the upper limit of normal; serum creatinine ≤1.5 times the normal value
  • The left ventricular ejection fraction (LVEF) was normal.
  • No uncontrollable infection.
  • Contraception for both male or female.
  • Informed consent obtained.
Exclusion Criteria
  • Pregnancy or lactating Women；
  • Allergic to ruxolitinib；
  • Active bleeding of the internal organs；
  • uncontrollable infection；
  • Serious mental illness;
  • Non-melanoma skin cancer history;
  • Patients unable to comply during the trial and/or follow-up phase;
  • Participate in other clinical research at the same time.
Ruxolitinib and Methylprednisolone as a First-line Treatment for Macrophage Activation Syndrome

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Ruxolitinib and Methylprednisolone as a First-line Treatment for Macrophage Activation Syndrome

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