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Not yet recruiting NCT07517185

The HIt HArd and hiT Early in Multiple Sclerosis Trial

Phase II Interventional Relapsing-remitting Multiple Sclerosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sequential treatment with rituximab and cladribine.
Who it may be relevant to
Registry conditions: Relapsing-remitting Multiple Sclerosis. Basic parameters: 18 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug 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.

Primary outcome measures

  • Treatment-related Serious Adverse Events [Time frame: From start of treatment until end of follow-up at 2 years.]
Secondary outcome measures (7)
  • Magnetic Resonance Imaging (MRI) lesions [Time frame: The first scan made after the treatment course has been completed (week 12) will be compared with the scan at 2 years to determine if new lesions have occurred.]
  • Relapses [Time frame: From start of treatment until the end of follow-up at 2 years.]
  • Disability [Time frame: EDSS at baseline will be compared with EDSS at end of follow-up at 2 years.]
  • Symbol Digit Modalities Test (SDMT) [Time frame: SDMT at baseline is compared with SDMT at end of follow-up at 2 years.]
  • Quality of life (physical) measured by MSIS-29 (Multiple Sclerosis Impact Scale) [Time frame: Baseline compared with end of follow-up at 2 years.]
  • Quality of life (MSIS-29 psychological) [Time frame: Baseline compared with end of follow-up at 2 years.]
  • Treatment-related Adverse Events [Time frame: From start of treatment to end of follow-up at 2 years.]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • Diagnosis of progressive MS,
  • Previous use of rituximab (or any other B-cell depleting monoclonal antibody) and/or cladribine,
  • 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,
  • Simultaneous treatment with other immunosuppressive drugs,
  • Infection with human immunodeficiency virus (HIV),
  • Active, severe infections (e.g. hepatitis or tuberculosis),
  • Severe cardiac disorder,
  • Moderate or severe renal impairment (eGFR <60).
  • Active malignancy,
  • No prior exposure to varicella virus,
  • Vaccination within 4 weeks of first dose of study medication,
  • Severe psychiatric condition.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Sweden · 4 centers
  • Falu Lasarett, Neurologen — Falun
  • Gävle sjukhus, Neurologmottagningen — Gävle
  • Centralsjukhuset Karlstad, Neurologi och Rehabiliteringskliniken — Karlstad
  • Uppsala University Hospital — Uppsala

Identifiers

NCT: NCT07517185 · HiHat · 2024-519700-28-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗