Multiple Sclerosis
Conditions
Interventions
Group 1: CONTACT is a multicentric retrospective analysis of routinely collected blood samples and patient chart data from PwMS in Germany who have been treated ocrelizumab, either newly started or sw
Sponsors
Roche Pharma AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Signed informed consent • Age >18 years • For patients who switched to ocrelizumab therapy, the date of the last DMT must be available. • At least three frozen blood samples, one taken at baseline before start of or switching to ocrelizumab treatment (but not more than four weeks before treatment start) and two taken at six and 12 months after ocrelizumab treatment start*. • MRIs should be available when made as follows: o For baseline: a maximum of one month before ocrelizumab treatment start o For all FU-timepoints after ocrelizumab treatment start: within eight weeks before and after the respective ocrelizumab infusion*, preferably one year apart * In case of ocrelizumab discontinuation after at least 3 completed ocrelizumab infusion cycles (600mg), data of respective patients will be further documented if blood samples and MRIs are available on a yearly basis according to the data collection plan. Patients who meet the following criterion will be excluded from the research project:
Exclusion criteria
Exclusion criteria: Treatment with anti-CD20 antibodies prior to baseline (Baseline is defined as collection date of the baseline blood sample before treatment initiation with ocrelizumab)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the impact of initiation of or switching to ocrelizumab therapy on the NfL level, using patient data from a real-world setting. The impact is assessed as the change from baseline in NfL level and will be evaluated separately for RMS patients and PPMS patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Investigate the NfL levels at baseline and at all follow-up (FU)-timepoints after initiation of or switching to ocrelizumab therapy (up to six years) • Change from baseline in NfL levels at all FU-timepoints after initiation of or switching to ocrelizumab therapy (up to six years) • Examine whether a patient’s disease progression is reflected in the course of patient’s NfL levels. Disease activity is recorded (up to six years after ocrelizumab initiation) as o Number of relapses (calculated annualized relapse rate [ARR]) o Increase in EDSS score o MRI activity (brain) ? Increase in number of lesions | — |
Countries
Germany
Contacts
Public ContactNatalie Joschko
Roche Pharma AG
Outcome results
None listed