A SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB IN PATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIA
- Conditions
- MSmultiple sclerosis10012303
- Registration Number
- NL-OMON52500
- Lead Sponsor
- Roche Nederland B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 25
- Able to comply with the study protocol, in the investigator's judgment
- Eligible for roll-over into the MN39158/LIBERTO study (including the female
patients who were pregnant during the parent studies and are still in the
safety follow up period) based on the investigator decision in a Roche
sponsored ocrelizumab P-trial upon risk-benefit assessment for continuous
treatment with ocrelizumab
- Meet re-treatment criteria with ocrelizumab
- Patients who became pregnant by chance between the last visit of the parent
study and screening of this study, as confirmed by pregnancy tests at
screening, will enter the safety follow-up immediately and restart the
treatment after birth and breastfeeding are over, as per retreatment criteria
- For women of childbearing potential: agreement to remain abstinent or use an
acceptable birth control method during the treatment period and for at least 6
months or longer after the final dose of ocrelizumab, as applicable in the
local ocrelizumab package leaflet.
- Hypersensitivity to ocrelizumab or to any of its excipients
- Patients in a severely immunocompromised state until the condition resolves
- Evidence of any adverse event potentially attributable to ocrelizumab,for
which the local label recommends permanent discontinuation
- Existence of a contra-indication as per ocrelizumab package leaflet
- Prohibited concomitant medication use
- Patients intending to become pregnant during the study or within 6 months
after the last dose of the study drug in the parent study
- Patients who discontinued ocrelizumab, exemption made for treatment
discontinuation due to pregnancy and breastfeeding for patients who continued
clinical study assessments in the safety follow-up of the parent study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To evaluate the effectiveness and the safety and tolerability of ocrelizumab<br /><br>therapy in MS patients who have participated in a Roche sponsored phase<br /><br>IIIb/IV-trial. See section 2 of the protocol for further information.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Different effectiveness measures evaluated for ocrelizumab in MS patients who<br /><br>have participated in a Roche sponsored phase IIIb/IV-trial. See Table 2 of the<br /><br>protocol for further information.</p><br>