RItuximab Versus FUmarate in Newly Diagnosed Multiple Sclerosis.
RIFUND-MS
1 other identifier
interventional
200
1 country
17
Brief Summary
A randomized phase 3 study comparing Rituximab with Dimethyl Fumarate in early Relapsing-Remitting Multiple Sclerosis and Clinically Isolated Syndrome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2016
Longer than P75 for phase_3
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 18, 2016
CompletedFirst Posted
Study publicly available on registry
April 21, 2016
CompletedStudy Start
First participant enrolled
May 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2021
CompletedOctober 12, 2021
October 1, 2021
5.2 years
April 18, 2016
October 11, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Freedom of relapse
The relative risk of experiencing a relapse during the two-year period for either compound.
Within 2 years
Study Arms (3)
Rituximab
EXPERIMENTALInfusion of Mabthera/Rituximab every 6 months
Dimethyl Fumarate
ACTIVE COMPARATORIntake of Tecfidera/Dimethyl Fumarate daily acc. to clinical practice.
Sodium Chloride solution
SHAM COMPARATORSham infusion with sodium chloride solution for the Tecfidera/Dimethyl Fumarate arm every 6 months (so that the examining physician will be blinded)
Interventions
Intake of Tecfidera/Dimethyl Fumarate daily acc. to clinical practice.
Placebo/Sham infusion every 6 months so that the examining physician (blinded) should not know which patient gets Mabthera or Tecfidera
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- Vaccination within 4 weeks of first dose of study medication.
- Documented allergy or intolerance to any of the investigational products.
- Severe psychiatric condition
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
South Älvsborg Hospital
Borås, Sweden
Falun Hospital
Falun, Sweden
Gävle Hospital
Gävle, Sweden
Saghlgrenska Hospital
Gothenburg, Sweden
Helsingborg Hospital
Helsingborg, Sweden
Karlstad Hospital
Karlstad, Sweden
Halland Hospital Kungsbacka
Kungsbacka, Sweden
Linköping University Hospital
Linköping, Sweden
Nyköping Hospital
Nyköping, Sweden
Örebro University Hospital
Örebro, Sweden
Östersund Hospital
Östersund, Sweden
Capio StGöran Hospital
Stockholm, Sweden
Danderyd hospital
Stockholm, Sweden
Fredrik Piehl
Stockholm, Sweden
Karolinska Hospital Huddinge
Stockholm, Sweden
Umeå University
Umeå, Sweden
Uppsala Academiska Hospital
Uppsala, Sweden
Related Publications (1)
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.
PMID: 35841908DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anders Svenningsson, MD, PhD
Dept.of Medicine, Sect.of Neurology, Danderyd Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD PhD
Study Record Dates
First Submitted
April 18, 2016
First Posted
April 21, 2016
Study Start
May 1, 2016
Primary Completion
July 1, 2021
Study Completion
August 1, 2021
Last Updated
October 12, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share