relapsing-remitting multiple sclerosis MedDRA version: 17.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Code: VAY736
Pharmaceutical Form: Powder for concentrate for solution for infusion
Current Sponsor code: VAY736
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration numb
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Male and female patients 18 to 55 years of age. -Diagnosis of MS as defined by the 2010 revised McDonald criteria (Polman, et. al. 2011). -A relapsing-remitting course of disease with: at least 1 documented relapse during the previous 12 months (but not within 30 days prior to randomization as per criterion 6), or a positive Gd-enhancing lesion on brain MRI scan at screening. -An Expanded Disability Status Scale (EDSS) score of 0-5.0 inclusive at screening. -No evidence of a relapse within 30 days prior to randomization. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 96 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -A manifestation of another type of MS other than RRMS. -Findings on screening or baseline brain MRI inconsistent with the diagnosis of MS. -History of chronic disease of the immune system other than MS, or a known immunodeficiency syndrome. -Unable to undergo MRI scans due to inter-alia, claustrophobia, incompatible cardiac pacemakers, ferromagnetic intracranial, Aneurysm clips, certain cochlear implants, and certain other ferromagnetic foreign bodies (e.g. tattoos containing metal) or electronic devices, or metallic implants incompatible with MRI. -Unable to receive gadolinium-based MRI contrast agents due to a history of hypersensitivity to gadolinium-based contrast agents, renal insufficiency or impairment. -Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during the course of the study and for 4 months following completion of the study. -Have received total lymphoid irradiation, bone marrow transplantation, alemtuzumab, cladribine, cyclophosphamide, mitoxantrone, or other immunosuppressive treatments with effects lasting longer than 6 months (wash-out times for other registered or putative immunomodulators or immunosupressants apply) - Patient may stop their current treatment only if considered not effective, not safe, or not tolerated by HCP and/or patient (for Czech Republic only)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine if a monoclonal antibody VAY736 can reduce disease activity in relapsing-remitting multiple sclerosis (RRMS) as compared to placebo.;Secondary Objective: To evaluate the safety and tolerability of VAY736 in patients with RRMS. To evaluate the effect of VAY736 on additional parameters observed on brain MRI scans including: - Number of all T1-weighted Gd-enhancing lesions - Number of new or enlarging T2-weighted lesions - T2 burden of disease (total volume of T2-weighted lesions) - Proportion of subjects without any new MRI disease activity (no new Gd-enhancing lesions nor new or enlarging T2 lesions) To evaluate the effect of VAY736 on the number of relapses ;Primary end point(s): Cumulative number of new Gd-enhancing lesions.;Timepoint(s) of evaluation of this end point: 8, 12, 16 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 4, 8, 12, 16 weeks;Secondary end point(s): -Number of new and cumulative number of new T1-weighted Gd-enhancing lesions. -Number of all T1-weighted Gd-enhancing lesions. -Cumulative number of new or enlarging T2-weighted Gd-enhancing lesions. -T2 burden of disease -Proportion of subjects without any new MRI disease activity. -The number of confirmed relapses at week 16 -Proportion of relapse-free patients over the 16 weeks of the treatment period -Number of patients with adverse events | — |
Countries
Czech Republic, Poland, Russian Federation, Ukraine, United States
Contacts
Public ContactInformacní služba - klin.hodnocení
Novartis s.r.o.
Outcome results
None listed