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Multiple Sclerosis, Relapsing-RemittingPhase 3RIFUND-MSNCT02746744

RItuximab Versus FUmarate in Newly Diagnosed Multiple Sclerosis.

A Phase 3 study testing Rituximab, Dimethyl fumarate and Sodium Chloride solution in people with Multiple Sclerosis, Relapsing-Remitting, run by Anders Svenningsson at 17 sites in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A randomized phase 3 study comparing Rituximab with Dimethyl Fumarate in early Relapsing-Remitting Multiple Sclerosis and Clinically Isolated Syndrome. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Multiple Sclerosis, Relapsing-Remitting
What is being tested?
Rituximab, Dimethyl fumarate and Sodium Chloride solution
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
200 participants
Where
17 sitesSweden
Study dates
May 2016to Aug 2021
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Diagnosis of Relapsing Remitting MS according to the 2017 revised McDonald cri-teria 27 OR one demyelinating episode in conjunction with at least one asympto-matic high intensity T2 lesion with size and location compatible with MS.
  • Untreated OR treated with first-line injectables (interferon or glatiramer acetate)
  • Between the age of 18 and 50 years (inclusive) of age
  • No more than ten years of disease duration
  • During the previous year, clinical or radiological disease activity defined as at least one of the following:
  • ≥ 1 relapse
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  • ≥ 2 T2 lesions
  • ≥ 1 Gd+ lesions
  • Expanded Disability Status Scale: 0 - 5,5 (inclusive)
  • In fertile females, willing to comply with effective contraceptive methods. These include birth control pills, surgical sterilization of patient or partner or intrauterine device. Non-fertile women is defined as more than 12 months of amenorrhea without an alternative medical cause or, in case of ambiguities, an follicle stimulation hormone level in the postmenopausal range.

Who cannot join

  • Diagnosis of Progressive MS
  • Pregnant or lactating women: human chorionic gonadotropin (s-HCG) will be tested on all women at screening, before each study-related infusion and in any situation where there is a reason to suspect pregnancy during the trial, eg delayed menstrual period more than five days above expected time.
  • Patients having contraindication for or otherwise not compliant with MRI investigations
  • Simultaneous treatment with other immunosuppressive drugs
  • Active, severe infections Signs of infections are assessed before inclusion and each study-related infusion through clinical examination and further evaluated by laboratory and other relevant investigations in case of suspected ongoing infection. Hepatitis serology (HBsAg and anti-HBc) will be evaluated before treatment onset.
  • Severe cardiac disorder, eg signs of congestive heart failure or coronary artery disease. This will be evaluated through clinical assessment before inclusion.
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  • Vaccination within 4 weeks of first dose of study medication.
  • Documented allergy or intolerance to any of the investigational products.
  • Severe psychiatric condition

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

Sweden17 sites

  • South Älvsborg Hospital

    Borås

  • Falun Hospital

    Falun

  • Gävle Hospital

    Gävle

  • Saghlgrenska Hospital

    Gothenburg

  • Helsingborg Hospital

    Helsingborg

  • Karlstad Hospital

    Karlstad

  • Halland Hospital Kungsbacka

    Kungsbacka

  • Linköping University Hospital

    Linköping

  • Nyköping Hospital

    Nyköping

  • Örebro University Hospital

    Örebro

  • Östersund Hospital

    Östersund

  • Capio StGöran Hospital

    Stockholm

  • Danderyd hospital

    Stockholm

  • Fredrik Piehl

    Stockholm

  • Karolinska Hospital Huddinge

    Stockholm

  • Umeå University

    Umeå

  • Uppsala Academiska Hospital

    Uppsala

Other trials in Sweden

About this study

Official title: RItuximab Versus FUmarate in Newly Diagnosed Multiple Sclerosis. A Randomized Phase 3 Study Comparing Rituximab With Dimethyl Fumarate in Early Relapsing-Remitting Multiple Sclerosis and Clinically Isolated Syndrome.

A randomized phase 3 study comparing Rituximab with Dimethyl Fumarate in early Relapsing-Remitting Multiple Sclerosis and Clinically Isolated Syndrome.

Read the detailed description

This is a prospective randomised phase 3 study comparing a novel treatment protocol of Rituximab with a present first line disease modifying drug regarding both clinical, radiological and biochemical parameters. This will be measured via clinical investigations, MRI and Cerebrospinal fluid analyses. Each patient will have one treating physician responsible for all ongoing medical questions and decisions regarding continuation in the study and one examining physician performing the blinded Expanded Disability Status Scale examination and assessments of exacerbations. The coordinating nurse will administer the study-related tests and administer the rituximab infusions. In order to keep the examining physician blinded the patients receiving disease modifying drug will receive infusions with sodium chloride solution at the same interval as the rituximab arm is receiving. In both instances an opaque cover bag will shield the content of the infusion solution. In this case the examining physician will not be able to identify rituximab patients in case of accidental meetings on the neurology unit.

Randomisation will be performed via a randomisation module in the national Swedish MS registry. The patients will be randomised in a 1:1 ratio and receive their treatments in accordance with clinical practice. Thus, the study will mimic the real-life situation in which the treatments will be administered which involves both positive and negative consequences. As positive consequence the result of the study will have a high degree of validity in relation to expected outcome in clinical practice. As negative consequence there may be psychological effects of knowing which medication one is receiving. Since both drugs probably are perceived as positive treatment options in MS today it is unlikely that there will be a predominant placebo effect of either of the treatment options.

Being tested
Rituximab, Dimethyl fumarate, Sodium Chloride solution
Medical subject headings
Multiple Sclerosis, Relapsing-Remitting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RituximabDrug

    Also called Mabthera

    Infusion of Mabthera/Rituximab every 6 months

  • Dimethyl fumarateDrug

    Also called Tecfidera

    Intake of Tecfidera/Dimethyl Fumarate daily acc. to clinical practice.

  • Sodium Chloride solutionDrug

    Also called Sodium Chloride

    Placebo/Sham infusion every 6 months so that the examining physician (blinded) should not know which patient gets Mabthera or Tecfidera

Study groups in NCT02746744
Study groupRoleWhat they receive
RituximabExperimentalInfusion of Mabthera/Rituximab every 6 months
Receives: Drug: Rituximab
Dimethyl FumarateActive comparatorIntake of Tecfidera/Dimethyl Fumarate daily acc. to clinical practice.
Receives: Drug: Dimethyl fumarate; Drug: Sodium Chloride solution
Sodium Chloride solutionSham comparatorSham infusion with sodium chloride solution for the Tecfidera/Dimethyl Fumarate arm every 6 months (so that the examining physician will be blinded)
Receives: Drug: Dimethyl fumarate; Drug: Sodium Chloride solution

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Freedom of relapse

    The relative risk of experiencing a relapse during the two-year period for either compound.

    Measured: Within 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2016 (estimated)
  2. Study startMay 2016
  3. Primary completionJul 2021
  4. Study completionAug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02746744
Sponsor's protocol ID
EudraCT 2015-004116-38
Acronym
RIFUND-MS
Status last verified
Oct 2021
First submitted
18 Apr 2016
Last updated
12 Oct 2021
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Svenningsson A, Frisell T, Burman J, Salzer J, Fink K, Hallberg S, Hambraeus J, Axelsson M, Nimer FA, Sundstrom P, Gunnarsson M, Johansson R, Mellergard J, Rosenstein I, Ayad A, Sjoblom I, Risedal A, de Flon P, Gilland E, Lindeberg J, Shawket F, Piehl F, Lycke J. Safety and efficacy of rituximab versus dimethyl fumarate in patients with relapsing-remitting multiple sclerosis or clinically isolated syndrome in Sweden: a rater-blinded, phase 3, randomised controlled trial. Lancet Neurol. 2022 Aug;21(8):693-703. doi: 10.1016/S1474-4422(22)00209-5.

    PubMed 35841908

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rituximab, Dimethyl fumarate and Sodium Chloride solution in people with Multiple Sclerosis, Relapsing-Remitting, run by Anders Svenningsson at 17 sites in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Freedom of relapse (time frame: Within 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02746744, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2021.

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