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临床试验/NCT04998812
NCT04998812已完成4 期

A Phase IV Multicenter, Open-Label Study Evaluating B Cell Levels In Infants Potentially Exposed To Ocrelizumab During Pregnancy

Hoffmann-La Roche23 个研究点 分布在 5 个国家目标入组 70 人开始时间: 2022年4月13日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
70
试验地点
23
主要终点
Percentage of Infants With B Cell Levels (Cluster of Differentiation 19 [CD19+] Cells) Below the Lower Limit of Normal (LLN)
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study will evaluate the potential placental transfer of ocrelizumab in pregnant women with clinically isolated syndrome (CIS) or multiple sclerosis (MS) [in line with the locally approved indications] whose last dose of ocrelizumab was administered any time from 6 months before the last menstrual period (LMP) through to the first trimester (up to gestational week 13) of pregnancy, and the corresponding pharmacodynamic effects (B cell levels) in the infant.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 40 Years（Adult）
性别
Female
接受健康志愿者
否

入选标准

  • •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 and second obstetric ultrasound has been conducted before enrolment during the screening period
  • •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

排除标准

  • •Last exposure to ocrelizumab >6 months before the woman's LMP or later than the first trimester of pregnancy
  • •Gestational age at enrolment >30 weeks
  • •Non-singleton pregnancy
  • •Received the last dose of ocrelizumab at a different posology other than per the local prescribing information
  • •Lack of access to ultrasound pre-natal care as part of standard clinical practice
  • •Prior or current obstetric/gynecological conditions associated with adverse pregnancy outcomes
  • •Pre-pregnancy body mass index >35 kg/m2
  • •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
  • •Significant and uncontrolled 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
  • •Prior or current history of alcohol or drug abuse, or current use of tobacco
  • •Positive screening tests for hepatitis B
  • •Treatment with drugs known to have teratogenic effects
  • •Planned treatment with interferons, glatiramer acetate, or pulsed corticosteroids as a bridging therapy after the last ocrelizumab dose and throughout pregnancy
  • •Treatment with disease-modifying therapies for MS within their respective half-lives prior to the last ocrelizumab dose or prior to the LMP
  • •Treatment with natalizumab within 12 weeks prior to the LMP
  • •Treatment with teriflunomide within the last two years, unless measured plasma concentrations are <0.02 mg/L. If levels are >0.02 mg/L or not known, an accelerated elimination procedure is required
  • •Treatment with any investigational agent within 6 months or five half-lives of the investigational drug prior to the last ocrelizumab dose or prior to the LMP

研究组 & 干预措施

Infants

No Intervention

Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice were observed up to month 13 of age.

Pregnant Women with CIS or MS

Experimental

Pregnant women with CIS or MS (in line with the locally approved indications) receiving commercial ocrelizumab up to 6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13), due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice.

干预措施: Ocrelizumab (Drug)

结局指标

主要结局

Percentage of Infants With B Cell Levels (Cluster of Differentiation 19 [CD19+] Cells) Below the Lower Limit of Normal (LLN)

时间窗: At Week 6 of infant's life

The event rate (percentage of infants with B cell levels below LLN) and corresponding Clopper Pearson 95% CI were reported. B-cell reference ranges by week of life (absolute counts) are defined by Borriello et al. 2022.

次要结局

  • Percentage of CD19+ B Cell in the Infant Potentially Exposed to Ocrelizumab During Pregnancy(At Week 6 of infant's life)
  • Absolute CD19+ B Cell Count in the Infant Potentially Exposed to Ocrelizumab During Pregnancy(At Week 6 of infant's life)
  • Serum Concentration of Ocrelizumab in the Umbilical Cord Blood at Birth(Within 1 hour after delivery (at birth Day 1))
  • Serum Concentration of Ocrelizumab in the Infant at Week 6 of Life(At Week 6 of infant's life)
  • Serum Concentration of Ocrelizumab in the Mother(Baseline (gestational Weeks 24-30), gestational Week 35, and at delivery (within 24 hours after delivery) (at birth Day 1))
  • Percentage of Infants With Adverse Events(Up to 17 months)
  • Percentage of Mothers With Adverse Events(Up to 17 months)
  • Infant Characteristics at Birth: Body Weight(At birth (Day 1))
  • Infant Characteristics at Birth: Head Circumference(At birth (Day 1))
  • Infant Characteristics at Birth: Body Length(At birth (Day 1))
  • Percentage of Pregnancies Resulting in Live Births, Therapeutic Abortions, or Stillbirth(During pregnancy (anytime between 37 to 42 weeks of gestation) and at birth (at Day 1))
  • Mean Titers of Antibody Immune Responses to Measles, Mumps, and Rubella (MMR) Vaccination(Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13))
  • Mean Titers of Antibody Immune Responses to Diphtheria-Tetanus-Pertussis (DTP) Vaccine(Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13))
  • Percentage of Infants With Positive Humoral Response to DTP Vaccine(Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13))
  • Mean Titers of Antibody Immune Responses to Haemophilus Influenzae Type B (Hib) Vaccine(Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13))
  • Percentage of Infants With Positive Humoral Response to Hib Vaccine(Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13))
  • Mean Titers of Antibody Immune Responses to Hepatitis B Vaccine (HBV)(Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13))
  • Percentage of Infants With Positive Humoral Response to HBV(Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13))
  • Mean Titers of Antibody Immune Responses to 13-valent Pneumococcal Conjugate Vaccine (PCV-13)(Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13))
  • Percentage of Infants With Positive Humoral Response to PCV-13(Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13))
  • Percentage of Infants With Positive Humoral Response to MMR Vaccination(Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13))
  • Serum Concentration of Ocrelizumab in the Umbilical Cord Blood at Birth(Within 1 hour after delivery (at birth, Day 1))
  • Serum Concentration of Ocrelizumab in the Mother(Baseline (gestational Weeks 24-30), gestational Week 35, and at delivery (within 24 hours after delivery) (at birth, Day 1))
  • Percentage of Infants With Adverse Events(Up to approximately 71 weeks)
  • Percentage of Mothers With Adverse Events(Up to approximately 87.6 weeks)
  • Mean Titers of Measles, Immunoglobin G (IgG) Antibody in Response to MMR Vaccination(Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13))
  • Mean Titers of Mumps, IgG Antibody in Response to MMR Vaccination(Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13))
  • Mean Titers of Rubella, IgG Antibody in Response to MMR Vaccination(Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13))
  • Mean Titers of Corynebacterium Diphtheriae, IgG Antibody in Response to Diphtheria-Tetanus-Pertussis (DTP) Vaccination(Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13))
  • Mean Titers of Bordetella Pertussis, IgG Antibody in Response to DTP Vaccination(Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13))
  • Mean Titers of Tetanus Toxoid, IgG Antibody in Response to DTP Vaccination(Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13))
  • Percentage of Infants With Positive Humoral Response to DTP Vaccination(Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13))
  • Mean Titers of Antibody Immune Responses to Haemophilus Influenzae Type B (Hib) Vaccination(Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13))
  • Percentage of Infants With Positive Humoral Response to Hib Vaccination(Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13))
  • Mean Titers of Antibody Immune Responses to Hepatitis B Virus (HBV) Vaccination(Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13))
  • Percentage of Infants With Positive Humoral Response to HBV Vaccination(Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13))
  • Mean Titers of Antibody Immune Responses to 13-valent Pneumococcal Conjugate (PCV-13) Vaccination(Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13))
  • Percentage of Infants With Positive Humoral Response to PCV-13 Vaccination(Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13))

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (23)

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