Status:
COMPLETED
Norwegian Study of Oral Cladribine and Rituximab in Multiple Sclerosis (NOR-MS)
Lead Sponsor:
Oslo University Hospital
Collaborating Sponsors:
University of Oslo
Sykehuset Ostfold
Conditions:
Relapsing Multiple Sclerosis
Multiple Sclerosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The main aim and overall objective of the study is to assess whether rituximab is non-inferior to cladribine for the treatment of relapsing MS. Secondly, the investigators will test specific blood and...
Detailed Description
Multiple sclerosis (MS) is a demyelinating and neurodegenerative inflammatory disease of the central nervous system, affecting more than 12 000 patients in Norway and more than 2.2 mill patients world...
Eligibility Criteria
Inclusion
- Age between 18 and 65 years
- A diagnosis of relapsing MS according to the 2017 McDonald criteria
- Disease activity seen as either a clinical relapse or MRI activity during the last 12 months
- EDSS between 0 and 5.5
- Thrombocytes and leukocytes within normal range, and lymphocytes above 0.8 x10 9/L before first dose of study medication
- A) For women of childbearing potential: accepting to use adequate contraception in the trial period. If randomized to cladribine, women who use systemic hormonal contraception must accept to use additional barrier contraception during each treatment cycle and for four weeks after each treatment cycle.
- B) For men: If randomized to cladribine, accepting to use adequate contraception in the safety period of 6 months after each treatment cycle.
- Able to understand written and spoken Norwegian or English
- Able to complete treatment or follow-ups in the study (e.g. no contraindications for MRI, severe psychiatric disease, drug abuse or plans of moving)
- Signed informed consent
Exclusion
- Any contraindication or increased risk of side-effects from rituximab or cladribine (such as ongoing acute or chronic infection, live vaccination less than 4 weeks before start of treatment or planned live vaccination, immunocompromised, previous or active malignant disease, ongoing glucocorticoid treatment or allergy against any products of the medication)
- Previous use of any of cladribine, rituximab, alemtuzumab, ocrelizumab, hematopoietic stem cell therapy (HSCT) or other immunosuppression with long lasting effects
- Fingolimod or natalizumab treatment within the last six months before inclusion
- Current pregnancy or lactation
Key Trial Info
Start Date :
October 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2024
Estimated Enrollment :
267 Patients enrolled
Trial Details
Trial ID
NCT04121403
Start Date
October 16 2019
End Date
August 31 2024
Last Update
December 16 2024
Active Locations (11)
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1
Department of Neurology - Drammen, Vestre Viken HF
Drammen, Buskerud, Norway, 3004
2
Department of Neurology - Lillehammer, SI Lillehammer
Lillehammer, Oppland, Norway, 2629
3
Department of Neurology, Stavanger universitetssykehus
Stavanger, Rogaland, Norway, 4068
4
Department of Neurology - Førde, Helse Førde HF
Førde, Sogn Og Fjordane, Norway, 6807