RItuximab Versus FUmarate in Newly Diagnosed Multiple Sclerosis.

• Status: Completed
• Trial end date: 2021-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Anders Svenningsson
• Treatments: Dimethyl Fumarate; Pharmaceutical Solutions; Rituximab

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