A Study to Evaluate B Cell Levels in Infants Potentially Exposed to Ocrelizumab During Pregnancy - The Minore Study

Phase 1

• Conditions: Multiple Sclerosis (MS) or Clinically Isolated Syndrome (CIS) [in line with the locally approved indications]; MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 20.0Level: PTClassification code 10071068Term: Clinically isolated syndromeSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2021-000062-14-DE
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-25
• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• An informed consent form (ICF) for participation of the maternal subject and her unborn (for collection of blood samples, infant demographics and AE data) is signed and dated by the subject. Where applicable, the written ICF with respect to the infant is also signed and dated by the holder of parental rights as designated by the maternal subject
• Able and willing to comply with the study protocol, in the Investigator’s judgment
• 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)
Are the trial subjects under 18? yes
Number of subjects for this age range: 44
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 44
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Last exposure to ocrelizumab >6 months before the woman’s LMP or later than the first trimester (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 LPI
• Social circumstances that may preclude a woman from participating in the study
Exclusions related to obstetric and gynecological health
• Lack of access to ultrasound pre-natal care as part of standard clinical practice
• Women in whom aneuploid disorders or genetic disorders that cause major congenital malformations have been detected during first trimester prenatal screening (e.g.ultrasound, amniocentesis, genetic testing, nuchal translucency screening, chorionic villus sampling),or in whom any fetal anomalies (i.e., fetal biometry, fetal anatomy) have been detected during the morphology scan at around or before gestational week 18-20
• Documented history of disorders associated with adverse pregnancy outcomes, including but not limited to:
o History of preterm birth (gestational age <37 weeks) for any indication with or without fetal malformations
o History of spontaneous abortion (miscarriage) after the 1st trimester (i.e. after gestational week 13)
o History of stillbirth (defined as fetal loss after gestational week 22)
o History of pre-eclampsia/eclampsia
o History of a cervical pathology or intervention which may increase the risk of cervical incompetence (e.g. history of cervical cerclage, prior cervical conization or loop electrosurgical excision procedure)
• Prior or current history of any other gynecological or obstetric disease considered by the investigator to be associated with a high risk of adverse pregnancy outcomes in the current pregnancy
Exclusions related to general health
• Lack of peripheral venous access
• Pre-pregnancy body mass index >35 kilograms per square meter
• Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
• Prior or current history of primary or secondary immunodeficiency, or woman in an otherwise severely immunocompromised state. The woman may be re-screened and included if condition resolves significant and uncontrolled disease, such as cardiovascular, pulmonary, neurological, psychiatric, renal, hepatic, endocrine, or gastrointestinal or any other significant disease that may preclude a woman from participating in the study
• Women with known active malignancies or being actively monitored for recurrence of malignancy including solid tumors and hematological malignancies (except basal cell and in situ squamous cell carcinomas of the skin). Women with in situ carcinoma of the cervix of the uterus, even if excised and resolved with documented clean margins on pathology, are excluded from the study
• Prior or current history of alcohol or drug abuse, or current use of tobacco
Exclusions Related to Laboratory Findings
• Any abnormal screening laboratory value that is clinically relevant will be retested only once in order to rule out any progressive or uncontrolled underlying condition. The last value before study entry must meet study criteria
• Women with positive screening tests for hepatitis B, determined by a positive HBsAg result (current infection) or positive HBcAb titers (previous infection) will be excluded. Women with documented history of hepatitis B virus vaccination or positive hepatitis B surface antibody titers are eligi

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified