MS secondary progressive MS
Conditions
Interventions
Core: Treatment with BAF312 or placebo. Extension: Treatment with BAF312.
Sponsors
Novartis
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Core part: • 18 to 60 years (inclusive). • History of relapsing-remitting MS according to the 2010 Revised McDonald criteria. • Secondary progressive course of MS. • EDSS score of 3.0 to 6.5 (inclusive). • Documented EDSS progression in the 2 years prior to study of >=1 point for patients with EDSS =0.5 point for patients with EDSS >=6.0 at baseline. Should documented EDSS scores not be available, a written summary of the clinical evidence of disability progression in the previous 2 years, and retrospective assessment of EDSS score from data up to 2 years prior to screening must be submitted for central review. • No evidence of relapse or corticosteroid treatment within 3 months prior to randomization., Patients who completed the Core Part on: * double-blind treatment * open-label BAF312 * abbreviated schedule of assessments (with the exception of patients with BAF312-related AE or SAE) are eligible to enter the extension part.
Exclusion criteria
Exclusion criteria: • Active chronic disease (or stable but treated with immune therapy) of the immune system other than MS. • Diagnosis of macular edema during pre-randomization phase (patients with a history of macular edema will be allowed to enter the study provided that they do not have macular edema at the ophthalmic examination at the Screening Visit). • Negative for varicella-zoster virus IgG antibodies at Screening. • Live or live-attenuated vaccines within 2 months prior to randomization. • Have been treated with: BAF312, fingolimod within 2 months (M) or for more than 6 M, intravenous immunoglobulin within 2 M, dimethyl fumarate within 2 M, natalizumab within 6 M, immunosuppressive/chemotherapeutic medications within 6 M, cyclophosphamide within 12 M, rituximab, ofatumumab, ocrelizumab, cladribine within 24 M, mitoxantrone during previous 24 M or evidence of cardiotoxicity following mitoxantrone or a cumulative life-time dose of more than 60 mg/m2, teriflunomide within 2Y (unless teriflunomide plasma concentration is zero or without relevant biological significance) OR within 2W following successful accelerated elimination procedure as described in the product label • Abnormalities in the Suicidal Ideation section of the eC-SSRS (see protocol for details) • Homozygosity for CYP2C9*3 (will be tested at Screening), or refusal to test for CYP2C9*3 haplotype.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Timed 25-Foot walk (T25W), Nine Hole Peg Test (9-HPT), Paced Auditory Serial Addition Test (PASAT), MS Relapse, MRI, Symbol Digital Modalities Test (SDMT), Brief Visuospatial Memory Test-Revised (BVMT-R), Low Contract Visual Acuity (LCVA), adverse events, questionnaires QoL and Colombia Suicide Severity Rating, PK, pharmacogenomics (optional), biomarkers. | — |
Primary
| Measure | Time frame |
|---|---|
| Expanded Disability Status Score (EDSS). | — |
Countries
Netherlands
Outcome results
None listed