HiHat: Rituximab Followed by Cladribine in Relapsing-Remitting MS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2, open-label, single-arm study enrolling about 60 adults with relapsing-remitting MS. Participants receive two cycles of rituximab (1000 mg each, biweekly) followed by two cycles of cladribine (30 mg per cycle for three days, one month apart). They are followed for 24 months with clinical assessments, MRI scans, and biomarker analyses to monitor safety, MRI activity, relapses, disability progression, and quality of life. The primary goal is to determine if the rate of serious adverse events is acceptably low; secondary goals explore changes in MRI lesions, relapse rate, disability, and patient-reported outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Falu Lasarett, Neurologen
  Falun, Sweden Recruiting
• Centralsjukhuset Karlstad, Neurologi och Rehabiliteringskliniken
  Karlstad, Sweden Recruiting
• Uppsala University Hospital
  Uppsala, Sweden Recruiting
• Gävle sjukhus, Neurologmottagningen
  Gävle, Sweden Not yet recruiting

Study contacts

• Study coordinator: Joachim Burman, MD, PhD
• Email: joachim.burman@uu.se
• Phone: +46 18 611 50 88

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.