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

Sponsor
Beijing Friendship Hospital
Study ID
NCT05137496
Phase
PHASE3
Status
Unknown

Conditions

  • Macrophage Activation Syndrome

Eligibility Criteria

Sex
ALL
Age
1 Year - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Ruxolitinib — DRUG
    0.3mg/kg/d, iv.gtt, for at least 2 weeks
  • methylprednisolone — DRUG
    2mg/kg, d1-d5, gradually reduced, for at least 2 weeks

Study Details

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 .

Key Dates

Start date
Jun 1, 2022
Status verified
Mar 2022
Primary completion
Jun 1, 2023
Completion
Jun 1, 2024

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ruxolitinib+methylprednisolone
    Ruxolitinib and methylprednisolone administered as the first-line therapy

Primary Outcome Measure

Response rate [ Time Frame: Change from before and 2,4,6 and 8 weeks after initiating Ruxolitinib combined with methylprednisolone therapy ]

Central Contacts

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