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Ruxolitinib and methylprednisolone in Macrophage Activation Syndrome
NCT05137496Phase 3
Key facts
- Status
- Unknown
- Start
- Jun 2022
- Primary completion
- Jun 2023
- Sponsor
- Beijing Friendship Hospital
- Modality
- Small Molecules
- Drugs
- ruxolitinib
- Conditions
- macrophage activation syndrome (MAS)
01
Overview
Phase 3, open-label, single-arm trial of ruxolitinib in macrophage activation syndrome (MAS), sponsored by Beijing Friendship Hospital. Primary endpoints: Response rate at 8 weeks, Progression-Free Survival at 2 years and 1 more. Status: unknown.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Ruxolitinib + Methylprednisolone
Experimental arm receiving combination therapy as first-line treatment.
03
Who it enrols
Patients meeting HLH-04 criteria with autoimmune disease-associated MAS, no prior HLH induction therapy, and adequate organ function.
04
Endpoints
Primary
Response rate
Progression-Free Survival
Adverse events
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