A Study to Evaluate B Cell Levels in Infants Potentially Exposed to Ocrelizumab During Pregnancy - The MINORE Study
- Conditions
- Multiple Sclerosis (MS) or Clinically Isolated Syndrome (CIS) [in line with the locally approved indications]MedDRA version: 20.0Level: PTClassification code: 10071068Term: Clinically isolated syndrome Class: 100000004852MedDRA version: 20.1Level: PTClassification code: 10028245Term: Multiple sclerosis Class: 100000004852Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- CTIS2024-510974-25-00
- Lead Sponsor
- F. Hoffmann-La Roche AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 29
Age 18-40 years, inclusive, at screening., Have a diagnosis of MS or CIS (in line with the locally approved indications), Currently pregnant with singleton pregnancy at gestational week = 30 at enrolment, Documentation that first (12-week) and second (18 to 20-week) obstetric ultrasound (prenatal screening) has been conducted before enrolment, Documentation that the last exposure to ocrelizumab occurred up to 6 months before the LMP before the woman became pregnant OR during the first trimester of pregnancy (up to gestational week 13 inclusive)
Last exposure to ocrelizumab >6 months before the woman’s LMP or later than the first trimester (i.e., after gestational week 13), Gestational age at enrolment >30 weeks, Non-singleton pregnancy, Received last dose of ocrelizumab at a different posology other than per the local prescribing information, Social circumstances, that may preclude a woman from participating in the study, Additional exclusions related to obstetric and gynecological health, general health, laboratory findings, and medications
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method