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The HIt HArd and hiT Early in Multiple Sclerosis Trial
Sponsor: Uppsala University
Summary
The HiHat trial is a Phase 2 study aimed at evaluating the safety and feasibility of sequential treatment with rituximab and cladribine in patients with relapsing-remitting multiple sclerosis (RRMS). The study follows a prospective, open-label, single-arm design, with 60 RRMS patients receiving both treatments in a controlled regimen: two cycles of rituximab (1,000 mg each, biweekly) followed by two cycles of cladribine (30 mg per cycle for three days per cycle) spaced one month apart. Participants are monitored over 24 months through clinical assessments, MRI, and biomarker analyses. The primary objective is to evaluate whether the rate of serious adverse events (SAE) is acceptably low. Secondary objectives include assessing impacts on MRI lesion count, relapse rates, disability progression, quality of life, and safety.
Official title: The HIt HArd and hiT Early in Multiple Sclerosis Trial - HiHat Trial A Phase 2 Study of Sequential Treatment With Rituximab and Cladribine for Relapsing-remitting Multiple Sclerosis
Key Details
Gender
All
Age Range
18 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-04-15
Completion Date
2030-12-31
Last Updated
2026-04-08
Healthy Volunteers
No
Conditions
Interventions
Sequential treatment with rituximab and cladribine
Two cycles of rituximab (1,000 mg each, biweekly) followed by two cycles of cladribine (30 mg per cycle for three days per cycle) spaced one month apart.
Locations (4)
Falu Lasarett, Neurologen
Falun, Sweden
Gävle sjukhus, Neurologmottagningen
Gävle, Sweden
Centralsjukhuset Karlstad, Neurologi och Rehabiliteringskliniken
Karlstad, Sweden
Uppsala University Hospital
Uppsala, Sweden