Study of rituximab followed by cladribine for patients with relapsing-remitting multiple sclerosis with less than 10 years disease duration

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What is this study about?

This study involves people with relapsing-remitting multiple sclerosis, which is a condition where the immune system mistakenly attacks the protective covering of nerves in the brain and spinal cord, causing episodes of symptoms followed by periods of recovery. The study will use two medications given one after the other. First, patients will receive rituximab, which is given through an infusion into a vein. After that, they will receive cladribine, which is given as an injection under the skin. Several other medications may be used during the study to help manage symptoms or side effects, including aciclovir, cetirizine, methylprednisolone, paracetamol, and a combination of sulfamethoxazole and trimethoprim.

The purpose of this study is to find out whether the rate of serious unwanted effects from this treatment approach is low enough to be acceptable. The study will look at whether giving these two medications in sequence is safe for patients with this type of multiple sclerosis who have had the disease for less than ten years and who have shown signs of disease activity in the past year.

During the study, patients will be monitored for any serious unwanted effects related to the treatment. Doctors will also check for new signs of disease activity using brain scans called MRI to look for new areas of damage, track whether patients experience new episodes of symptoms, measure any changes in physical disability and thinking abilities, and take blood samples to measure certain substances that indicate nerve damage. The study will also assess how the treatment affects patients’ quality of life and will record any mild or moderate unwanted effects that are likely related to the study medications.

1 Initial treatment with rituximab

Your treatment will begin with rituximab, which is a medication that targets specific cells in your immune system.

This medication will be given to you through infusion, which means it will be administered directly into your vein over a period of time.

The specific dosage, frequency, and duration of rituximab treatment will be determined by the study protocol.

2 Sequential treatment with cladribine

Following the rituximab treatment, you will receive cladribine, another medication that affects your immune system.

Cladribine will be administered through subcutaneous injection, which means it will be injected under your skin.

The specific dosage, frequency, and duration of cladribine treatment will be determined by the study protocol.

3 Supportive medications during treatment

Throughout the trial, you may receive additional medications to manage symptoms or prevent infections.

Aciclovir may be given orally (by mouth) to prevent viral infections.

Cetirizine (an antihistamine) may be given orally to manage allergic reactions.

Methylprednisolone (a steroid) may be administered intravenously (through a vein) if needed.

Sulfamethoxazole and trimethoprim (antibiotics) may be given orally to prevent certain infections.

Bromhexine, sulfamethoxazole, and trimethoprim combination may be given orally if needed.

Paracetamol (pain reliever) or paracetamol with codeine and buclizine may be given orally for pain management.

The specific dosages and timing of these supportive medications will be determined based on your individual needs during the trial.

4 Regular monitoring visits

You will attend regular monitoring visits throughout the trial period.

During these visits, your disability status will be assessed using the EDSS (Expanded Disability Status Scale), which measures your physical disability level.

Your cognitive function will be evaluated using the SDMT (Symbol Digit Modalities Test), which assesses your information processing speed.

Blood samples will be taken to measure pNfL (plasma neurofilament light chain) and pGFAp (plasma glial fibrillary acidic protein), which are markers that indicate nerve damage.

You will complete the MSIS-29 (Multiple Sclerosis Impact Scale), a questionnaire that assesses how multiple sclerosis affects your daily life.

5 MRI scans

You will undergo MRI scans (magnetic resonance imaging) at specified intervals during the trial.

These scans will be used to detect new lesions in your brain and to monitor disease activity.

The scans will look for T2 lesions (areas of damage visible on specific MRI sequences) and gadolinium enhancing lesions (active areas of inflammation that show up when contrast dye is used).

6 Safety monitoring

Throughout the trial, you will be monitored for any adverse events or side effects.

Any serious adverse events or reactions to the study medications will be recorded and assessed.

Your healthcare team will evaluate whether any adverse events are related to the study medications.

7 End of follow-up assessment

At the end of the follow-up period, you will undergo final assessments.

These will include a final MRI scan to check for new lesions.

Your disability status, cognitive function, and quality of life will be assessed one last time.

Final blood samples will be collected to measure nerve damage markers.

The study is expected to continue until December 2030.

Who Can Join the Study?

You must have a diagnosis of relapsing-remitting multiple sclerosis, which is a form of multiple sclerosis where symptoms come and go in episodes, confirmed using the 2017 revised McDonald criteria, which are specific medical guidelines doctors use to diagnose this condition.
You must have had disease activity in the past year, which means at least one of the following: a clinical relapse, meaning your symptoms got worse or new symptoms appeared; or at least 2 T2 lesions seen on an MRI scan, which are areas of damage in your brain or spinal cord that show up on this special imaging test; or gadolinium enhancing lesions on an MRI scan, which are active areas of inflammation that light up when a special contrast dye called gadolinium is used during the scan.
You must be between 18 and 50 years old, including both ages.
Your multiple sclerosis must have been diagnosed 10 years ago or less.
Your EDSS score must be between 0 and 5.5, including both numbers. The EDSS is the Expanded Disability Status Scale, which is a way doctors measure how much multiple sclerosis affects your ability to walk and perform daily activities, with 0 meaning no disability and higher numbers meaning more disability.
You must be able to understand the study and sign an informed consent form, which is a document that explains the study and confirms you agree to participate.

Who Cannot Join the Study?

The source data does not provide specific exclusion criteria, which are reasons why a patient cannot participate in the study
Without detailed exclusion information, it is not possible to list specific conditions or situations that would prevent participation
Typically, clinical trials have exclusion criteria related to other health conditions, previous treatments, laboratory test results, or medications that might interfere with the study
In this case, the trial information focuses on patients with relapsing-remitting multiple sclerosis, which is a type of multiple sclerosis where symptoms come and go in episodes, with disease duration of less than 10 years
The study examines the safety of using two medications in sequence: rituximab followed by cladribine, which are treatments that affect the immune system

Where you can join this trial?

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Other Sites

Site Name	City	Country
Region Dalarna	Falun	Sweden
Region Halland	Varberg	Sweden
Udmkgtb Uxexxjvxak Hblgljmm	Uppsala	Sweden
Rtnuuv Vgfecspxb	Karlstad	Sweden

Trial status

Country	Status	Recruitment Start
Sweden	Not yet recruiting	01.01.2026

Trial locations

Investigated drugs:

Rituximab is a medication that works by targeting and reducing certain immune cells in your body called B cells. It is given through an infusion into a vein and is used to help control the immune system’s attack on the nervous system in multiple sclerosis.

Cladribine is a medication that also works by reducing specific immune cells that may be attacking the nervous system. It is taken as tablets by mouth and helps to decrease the activity of multiple sclerosis by controlling the overactive immune response.

Investigated diseases:

Multiple sclerosis

Relapsing-Remitting Multiple Sclerosis – Relapsing-remitting multiple sclerosis is a form of multiple sclerosis characterized by clearly defined attacks of neurological symptoms followed by periods of partial or complete recovery. During relapses, new symptoms appear or existing ones worsen, which can last from days to weeks. Between attacks, the disease remains stable without progression of symptoms. Common symptoms include vision problems, numbness or tingling in limbs, muscle weakness, balance difficulties, and fatigue. This pattern of relapses and remissions is the most common form of multiple sclerosis at disease onset. Over time, the frequency and severity of relapses may vary from person to person.

Trial ID:

2024-519700-28-01

Protocol code:

HiHat

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of rituximab followed by cladribine for patients with relapsing-remitting multiple sclerosis with less than 10 years disease duration

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?