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Cheaper MS drug could match pricey standard in major trial

NCT ID NCT04688788

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Aug 18, 2026 · Updated 3 times

Summary

This phase 3 trial tests whether rituximab, a cheaper drug, works as well as ocrelizumab for active multiple sclerosis. About 600 adults with relapsing or progressive MS will receive one of the two drugs. The main goal is to see if rituximab can prevent new brain lesions as effectively as ocrelizumab.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
rituximab and ocrelizumab (drugs that target immune cells to reduce MS activity)
What this could lead to
If rituximab works as well as ocrelizumab, it could offer a more affordable treatment option for multiple sclerosis.
What could go wrong
This is a non-inferiority trial, so rituximab may turn out to be less effective or have different side effects. Results may not apply to all MS types.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

600 people

The number who actually took part.

Started

Apr 2021

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * MS diagnosis and definition of disease course according to the 2017 McDonald criteria * Expanded disability status scale (EDSS) ≤6.5 * Fulfilling criteria for active MS: * Treatment naïve relapsing remitting multiple sclerosis (RRMS) patients (never treated, or no DMT the previous 2 years): 1. ▪≥2 relapse previous 12 months OR 2. 1 relapse previous 12 months with severe residual symptoms and EDSS ≥ 3.0 OR 3. 1 relapse previous 12 months AND ≥9 T2 lesions on brain and/or spinal cord MRI AND * 1 contrast-enhancing lesion or ≥1 new or enlarging T2 lesion on brain and/or spinal cord MRI previous 12 month * Previously treated RRMS patients: 1. ≥1 relapse previous 12 months OR 2. ≥1 contrast-enhancing lesion or ≥2 new/enlarging T2 lesions on brain and/or spinal cord MRI previous 12 months * Progressive MS patients: 1. ≥1 relapse previous 12 months OR 2. ≥1 contrast-enhancing lesion previous 12 months or ≥1 new/enlarging T2 lesions on brain and/or spinal cord MRI previous 12 months or ≥2 new or enlarging T2 lesion on brain and/or spinal cord MRI previous 24 months OR 3. Increased levels of neurofilament light chain (NFL) in serum or cerebrospinal fluid (CSF) in sample collected previous 12 months. Progressive MS patients not fulfilling the clinical/MRI criteria for active disease, may qualify for inclusion in the study if: (A) CSF NFL level (measured with NF-Light® ELISA assay from Uman Diagnostics or Simoa): * 18 to 40 years \>560 ng/l * 41 to 60 years \>890 ng/l * 61 to 65 years \>1850 ng/l or (B) Serum NFL level (measured with Simoa™ NF-light® Advantage Kit) o Increased sNFL based on individual age-determined cut-off: \>4.19 × 1.029\^age ng/L OR o Increased sNFL based age-partitioned cut-offs: * 18 to 20 years \>7.4 ng/L * 21 to 30 years \>9.9 ng/L * 31 to 40 years \>13.1 ng/L * 41 to 50 years \>17.5 ng/L * 51 to 60 years \>23.3 ng/L * 61 to 65 years \>30.9 ng/L * Signed written informed consent Exclusion Criteria: * Pregnancy or breast feeding * Lack of effective contraception for women of child-bearing potential (effective contraception include oral contraception, intrauterine devices and other forms of contraception with failure rate \<1%) * Receipt of a live or live-attenuated vaccine within 6 weeks prior to randomization * Known active malignant disease * Severe heart failure (New York Heart Association Class IV) or severe, uncontrolled cardiac disease * Positive test for HIV, hepatitis B or C, or symptoms or signs of active tuberculosis in a patient with a positive Quantiferon test. * Negative test for varicella zoster * Lymphopenia grade 2 (0.5 to 0.8 × 10\^9/L) or higher grades of lymphopenia. In case of switching from fingolimod, siponimod or ozanimod lymphopenia is accepted at screening visit. Patients switching from dimethylfumarate who have persistent lymphopenia 5 to 6 weeks after stopping dimethylfumarate can be included if lymphopenia is grade 2 or lower, and treating phycisian judge CD20-depleting therapy safe. * Neutropenia grade 2 (1.0 to 1.5 × 10\^9/L) or higher grades * Thrombocytopenia grade 2 (50 to 75 × 10\^9/L) or higher grades * Previous treatment with alemtuzumab or hematopoietic stem-cell transplantation * Previous treatment with cladribine, CD20-depleting antibodies, daclizumab or other immune suppressive treatment which is judged to still exert immune suppressive effect by treating physician * Methylprednisolone treatment within 1 month of baseline visit * Findings on the screening MRI judged to preclude participation by the treating physician * Other diseases judged to be relevant by the treating physician * Contraindication to MRI * Known allergy or hypersensitivity to rituximab or ocrelizumab

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Danish Multiple Sclerosis Center, Rigshospitalet

    Glostrup Municipality, Copenhagen, 2600, Denmark

  • Department of Neurology, Aalborg University Hospital

    Aalborg, 9000, Denmark

  • Department of Neurology, Aarhus University Hospital

    Aarhus, 8200, Denmark

  • Department of Neurology, Herlev Hospital

    Herlev, 2730, Denmark

  • Department of Neurology, Hospital of South West Jutland, Esbjerg

    Esbjerg, 6700, Denmark

  • Department of Neurology, Hospital of Southern Jutland, Sønderborg

    Sønderborg, 6400, Denmark

  • Department of Neurology, Kolding Hospital

    Kolding, 6000, Denmark

  • Department of Neurology, Nordsjællands Hospital i Hillerød

    Hillerød, 3400, Denmark

  • Department of Neurology, Odense University Hospital

    Odense, 5000, Denmark

  • Department of Neurology, Regionshospitalet Holstebro

    Holstebro, 7500, Denmark

  • Department of neurology, Regionshospitalet Viborg

    Viborg, 8800, Denmark

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