Rituximab for Multiple System Atrphy

• Status: Recruiting
• Trial end date: 2024-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Neuroprotective or anti-inflammatory strategies are invaluable in multiple system atrophy (MSA) due to its rapid progression with fatal prognosis. We evaluated the efficacy of rituximab in patients with MSA-cerebellar type (MSA-C).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: First Affiliated Hospital of Fujian Medical University
• Treatments: Rituximab

Criteria

Inclusion Criteria:

• Age 18-80 years

• Patients with probable MSA-C or it's mimic (tropical spastic paraparesis)

• Baseline unified MSA rating scale scores of 30 to 50

• MMSE> 24

• Disease duration < 5 years

Exclusion Criteria:

• Anticipated survival of at least 3 years

• Inability to undergo neuroimaging with Magnetic Resonance

• Clinically significant hepatic disease as demonstrated by history, clinical exam (ascites, varices), or laboratory findings (LFTs >2x normal, coagulopathy as described)

• Comorbid conditions likely to complicate therapy including but not limited to the following: a history of New York Heart Association class II, III, or IV Congestive Heart Failure; end-stage acquired immune deficiency syndrome

• Pregnancy

• Malignancy (history of or active)

• Concomitant use with antineoplastic, immunosuppressive or immune modulating therapies