Tests Rituximab Followed by Cladribine in Early Relapsing Multiple Sclerosis
Tests rituximab followed by cladribine in adults with early relapsing-remitting multiple sclerosis.
Plain-language title generated from the registry record
Registry title: The HIt HArd and hiT Early in Multiple Sclerosis Trial
Key facts
- Where
- Falun, Gavle, Karlstad, and Uppsala, SwedenSee the 4 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 50 years old?
Source: NCT07517185, who can take part
Where in Sweden
- Region DalarnaFalun, SwedenTaking people
- Region GaevleborgGavle, SwedenTaking people
- Region VaermlandKarlstad, SwedenTaking people
- Uppsala University HospitalUppsala, SwedenTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Uppsala University
- Trial code
- NCT07517185EU 2024-519700-28-01
- Record updated
- 22 October 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Diagnosis of RRMS according to the 2017 revised McDonald criteria,; With disease activity within the preceding year in the form of: a clinical relapse, and/or evidence of ≥2 T2 lesions on MRI scan, and or presence of gadolinium enhancing lesions on an MRI scan,; Age 18 - 50 years (inclusive) of age,; Disease duration ≤10 years (since MS diagnosis),; EDSS 0 - 5.5 (inclusive),; Signed informed consent.
Exclusion: Previous use of rituximab (or any other B-cell depleting monoclonal antibody) and/or cladribine,; Simultaneous treatment with other immunosuppressive drugs,; No prior exposure to varicella virus,; Vaccination within 4 weeks of first dose of study medication,; Infection with human immunodeficiency virus (HIV),; Active, severe infections (e.g. hepatitis or tuberculosis),; Severe cardiac disorder,; Active malignancy,; Severe psychiatric condition; Moderate or severe renal impairment (eGFR <60); Diagnosis of progressive MS,; Pregnant or lactating women,; Unwilling to use contraception during the treatment period and the first year after completing the treatment course,; Patients having contraindication for or otherwise not compliant with MRI investigations,.