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RItuximab Versus FUmarate in Newly Diagnosed Multiple Sclerosis. (RIFUND-MS)

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ClinicalTrials.gov Identifier: NCT02746744
Recruitment Status : Active, not recruiting
First Posted : April 21, 2016
Last Update Posted : September 9, 2020
Sponsor:
Information provided by (Responsible Party):
Anders Svenningsson, Karolinska Institutet

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

Condition or disease Intervention/treatment Phase
Multiple Sclerosis, Relapsing-Remitting Drug: Rituximab Drug: Dimethyl fumarate Drug: Sodium Chloride solution Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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.
Actual Study Start Date : May 2016
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Rituximab
Infusion of Mabthera/Rituximab every 6 months
Drug: Rituximab
Infusion of Mabthera/Rituximab every 6 months
Other Name: Mabthera

Active Comparator: Dimethyl Fumarate
Intake of Tecfidera/Dimethyl Fumarate daily acc. to clinical practice.
Drug: Dimethyl fumarate
Intake of Tecfidera/Dimethyl Fumarate daily acc. to clinical practice.
Other Name: Tecfidera

Drug: Sodium Chloride solution
Placebo/Sham infusion every 6 months so that the examining physician (blinded) should not know which patient gets Mabthera or Tecfidera
Other Name: Sodium Chloride

Sham Comparator: Sodium Chloride solution
Sham infusion with sodium chloride solution for the Tecfidera/Dimethyl Fumarate arm every 6 months (so that the examining physician will be blinded)
Drug: Dimethyl fumarate
Intake of Tecfidera/Dimethyl Fumarate daily acc. to clinical practice.
Other Name: Tecfidera

Drug: Sodium Chloride solution
Placebo/Sham infusion every 6 months so that the examining physician (blinded) should not know which patient gets Mabthera or Tecfidera
Other Name: Sodium Chloride




Primary Outcome Measures :
  1. Freedom of relapse [ Time Frame: Within 2 years ]
    The relative risk of experiencing a relapse during the two-year period for either compound.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
    • ≥ 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.

Exclusion Criteria:

  • 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.
  • Vaccination within 4 weeks of first dose of study medication.
  • Documented allergy or intolerance to any of the investigational products.
  • Severe psychiatric condition

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02746744


Locations
Show Show 17 study locations
Sponsors and Collaborators
Anders Svenningsson
Investigators
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Principal Investigator: Anders Svenningsson, MD, PhD Dept.of Medicine, Sect.of Neurology, Danderyd Hospital
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Responsible Party: Anders Svenningsson, MD PhD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02746744    
Other Study ID Numbers: EudraCT 2015-004116-38
First Posted: April 21, 2016    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Rituximab
Dimethyl Fumarate
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Dermatologic Agents
Immunosuppressive Agents