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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02746744
Date of registration: 18/04/2016
Prospective Registration: Yes
Primary sponsor: Anders Svenningsson
Public title: RItuximab Versus FUmarate in Newly Diagnosed Multiple Sclerosis. RIFUND-MS
Scientific 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.
Date of first enrolment: May 2016
Target sample size: 200
Recruitment status: Active, not recruiting
URL:  https://clinicaltrials.gov/show/NCT02746744
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Investigator).  
Phase:  Phase 3
Countries of recruitment
Sweden
Contacts
Name:     Anders Svenningsson, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  Dept.of Medicine, Sect.of Neurology, Danderyd Hospital
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 50 Years
Gender: All
Health Condition(s) or Problem(s) studied
Multiple Sclerosis, Relapsing-Remitting
Intervention(s)
Drug: Dimethyl fumarate
Drug: Rituximab
Drug: Sodium Chloride solution
Primary Outcome(s)
Freedom of relapse [Time Frame: Within 2 years]
Secondary Outcome(s)
Secondary ID(s)
EudraCT 2015-004116-38
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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