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Research summary · AI summary · not yet reviewedHuman studyPhase 2Trial registry
Safety of Sequential Rituximab and Cladribine Treatment in Relapsing-Remitting MS Patients
The HiHat trial is underway to assess the safety of rituximab followed by cladribine in individuals with relapsing-remitting multiple sclerosis (RRMS). It aims to determine if the rate of serious adverse events (SAEs) is low following this sequential treatment.
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This plain-English summary was written by AI from a published abstract and may contain errors. It is not medical advice. Read the original study and talk to your MS team before making decisions about treatment.
Why it matters
Understanding the safety of this treatment combination could inform future strategies for managing RRMS and potentially improve patient outcomes if proven safe.
What this does not prove
Results are not yet available from this Phase 2 trial, and the planned enrollment and endpoints do not constitute findings.
Next milestone
No next milestone was established from the available source.
Study facts
- Study design
- Interventional
- Participants / samples
- Not reported
- Randomised
- No
- Controlled
- Not reported
- Primary endpoint met
- Not reported
- Relevant MS type
- RRMS
- Publication date
- Not reported
- Evidence reviewed
- Trial registry record
- Regulatory approval
- Not reported
- Research areas
- Other
Original sources
- Trial registrationThe HIt HArd and hiT Early in Multiple Sclerosis Trial ↗
Supporting passages (10)
study phaseThe 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).
study designThe 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.
subjectsThe study population will consist of subjects with RRMS with less than 10 years disease duration.
randomizedThe 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.
peer reviewedNo results are posted.
research categories"briefSummary": "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).
relevant ms types"eligibilityCriteria": "Inclusion Criteria:\n\n* Diagnosis of RRMS according to the 2017 revised McDonald criteria,\n* 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,\n* Age 18 - 50 years (inclusive) of age,\n* Disease duration ≤10 years (since MS diagnosis),\n* EDSS 0 - 5.5 (inclusive),\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Diagnosis of progressive MS,\n* Previous use of rituximab (or any other B-cell depleting monoclonal antibody) and/or cladribine,\n* Pregnant or lactating women,\n* Unwilling to use contraception during the treatment period and the first year after completing the treatment course,\n* Patients having contraindication for or otherwise not compliant with MRI investigations,\n* Simultaneous treatment with other immunosuppressive drugs,\n* Infection with human immunodeficiency virus (HIV),\n* Active, severe infections (e.g.
primary endpoint"description": "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.
findings"description": "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.
limitationsNo results are posted. Planned enrolment and endpoints are not findings.
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