G35.1
Conditions
Interventions
Group 1: Multiple sclerosis (MS) is a chronic, immune-mediated disease of the central nervous system affecting more than 2.8 million people worldwide and remaining the leading cause of non-traumatic d
Sponsors
Roche Pharma AG
Eligibility
Sex/Gender
All
Age
55 Years to No maximum
Inclusion criteria
Inclusion criteria: • Patients aged 55 years or older at the start of ocrelizumab treatment. • Start of OCR start only after 01.02.2018 • Documented diagnosis of relapsing-remitting multiple sclerosis (RMS) in the patient’s medical records. • Availability of informed consent. • At least two years of documented ocrelizumab treatment in the patient’s medical history.
Exclusion criteria
Exclusion criteria: • Patients younger than 55 years at the start of ocrelizumab treatment. • Documented diagnosis of primary progressive multiple sclerosis (PPMS) • Lack of informed consent for data use
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the ROAD trial is the retrospective assessment of the long-term efficacy of ocrelizumab in patients aged 55 years and older with relapsing-remitting multiple sclerosis (RRMS), with a focus on the time to first confirmed disability progression (CDP). Disability progression is defined as changes in the Expanded Disability Status Scale (EDSS) score compared to the baseline score (V0). Disability progression is considered confirmed if the EDSS score increases by a minimum amount, depending on the patient's baseline score: • Increase of = 1.5 points if the baseline EDSS is 0. • Increase of = 1.0 points if the baseline EDSS is between 1.0 and 5.0. • Increase of = 0.5 points if the baseline EDSS is = 5.5. | — |
Secondary
| Measure | Time frame |
|---|---|
| The ROAD study defines several secondary endpoints that aim to characterise the clinical efficacy, immunological status and safety profile of ocrelizumab in older patients (= 55 years) over a period of up to seven years. The secondary endpoints are divided into the following areas: 1. Clinical efficacy (relapse rate and MRI) The following parameters will be assessed to further characterise disease activity: • Annualised Relapse Rate (ARR): calculation of the total number of relapses divided by the person-years over the entire study period,. • MRI activity: ? Mean number of gadolinium-enhancing (Gd+) T1 lesions and new or enlarging T2 lesions at all available follow-up time points. ? Annualised incidence rate of new Gd+ T1 lesions and new/enlarging T2 lesions. ? Proportion of patients with no detectable MRI activity (‘No MRI activity’). • In addition, disease progression confirmed over 48 weeks is listed as a secondary endpoint in the context of EDSS changes. 2. Immunological parameters A key focus is on monitoring humoral immunity under B-cell depletion: • Immunoglobulin levels: mean change from baseline in IgG and IgM levels at documented time points (months 6, 12, 24, 36, 48, 60, 72 and 84),. • Hypogammaglobulinaemia: Proportion of patients with IgG or IgM levels below the lower limit of normal (defined as < 5.56 g/L for IgG and < 0.40 g/L for IgM). • Replacement therapy: Proportion of patients with low immunoglobulin levels receiving immunoglobulin replacement therapy and analysis of the duration of this therapy. 3. Description of the following parameters: • Comorbidities: Proportion of patients per comorbidity (e. g. infections, malignancies, fatigue) at baseline. • Adverse events (AEs): Incidence rates of adverse events, expressed per 100 patient-years (PY) over the entire study period. • Concomitant medications: Proportion of patients taking concomitant medications at baseline and at the time of documentation. | — |
Countries
Germany
Contacts
Public ContactLukas Cepek
Neuro Point, Ulm
Outcome results
None listed