The HIt HArd and hiT Early in Multiple Sclerosis Trial
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-50
SponsorUppsala University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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),
Disqualifiers
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,
Trial design
Design model
Single group
Treatments tested in this trial
Sequential treatment with rituximab and cladribine
DrugTwo 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.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Patients with relapsing-remitting multiple sclerosis (RRMS)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Treatment-related Serious Adverse Events
The primary objective of the study is to evaluate whether the SAE rate associated with sequential treatment of rituximab followed by cladribine is acceptably low. The proportion of patients with at least one treatment-related SAE (relationship ≥ possible) will be reported.
Time frame
From start of treatment until end of follow-up at 2 years.Secondary outcomes
1
Magnetic Resonance Imaging (MRI) lesions
Proportion of patients with a new MRI lesion will be reported.
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.2
Relapses
The proportion of patients with at least one confirmed clinical relapse will be reported.
Time frame
From start of treatment until the end of follow-up at 2 years.3
Disability
The proportion of patients with confirmed disability worsening, rated with the Kurtzke Expanded Disability Status Scale (EDSS, ranges from 0 to 10).
Time frame
EDSS at baseline will be compared with EDSS at end of follow-up at 2 years.4
Symbol Digit Modalities Test (SDMT)
The proportion of patients with worsened, unchanged, or improved SDMT (score range 0-110, higher numbers are better) will be reported. A change by at least 4 points on the SDMT will be considered a clinically meaningful change.
Time frame
SDMT at baseline is compared with SDMT at end of follow-up at 2 years.Sponsors and contacts
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Source ClinicalTrials.gov