Ground Truth
Inclusion Criteria:Eligible to receive ocrelizumab per the United States Package Insert (USPI)Able to comply with the study protocol, in the investigator's judgmentAge 18-55 years, inclusiveHave a diagnosis of PPMS or RMS, confirmed per the revised 2017 McDonald criteriaExpanded Disability Status Scale (EDSS) score of 0 to 6.5, inclusiveFor women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of <1% per year during the treatment period and for at least 6 months after the last dose of study treatment (per the USPI)Exclusion Criteria:Experienced serious IRR(s)History of life-threatening infusion reaction to ocrelizumabKnown presence of other neurological disordersPregnancy or lactation, or intention to become pregnant during the studyAny concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the studySignificant, uncontrolled disease, such as cardiovascular (including cardiac arrhythmia), pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine, and gastrointestinal or any other significant disease that may preclude patient from participating in the studyCongestive heart failureKnown active bacterial, viral, fungal, mycobacterial infection or other infection or any severe episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks prior to baseline visit or oral antibiotics within 2 weeks prior to baseline visitHistory of or currently active primary or secondary immunodeficiencyHistory or known presence of recurrent or chronic infection (e.g., HIV, syphilis, tuberculosis)History of recurrent aspiration pneumonia requiring antibiotic therapyHistory of malignancy, including solid tumors and hematological malignancies,except basal cell, in situ squamous cell carcinoma of the skin, and in situ carcinoma of the cervix of the uterus that have been excised with clear marginsHistory of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodiesHistory of alcohol or drug abuse within 24 weeks prior to enrollmentReceipt of a live vaccine within 6 weeks prior to enrollmentSystemic corticosteroid therapy within 4 weeks prior to enrollmentContraindications to or intolerance of oral or IV corticosteroids, including IV methylprednisolone (or equivalent steroid) administered according to the country labelTreatment with alemtuzumabTreatment with a B-cell targeted therapies other than ocrelizumabTreatment with a drug that is experimentalAbnormal laboratory results per local laboratory standards and investigator assessment
Prediction
## Modified Eligibility Criteria for Version 1 of the Ocrelizumab Study Protocol
Based on the provided text, here are the modified eligibility criteria for the Ocrelizumab study protocol, Version 1, incorporating the evidence from the document:
**Inclusion Criteria:**
* **Age:** 18-55 years, inclusive
* **Diagnosis:** PPMS or RMS, confirmed per the revised 2017 McDonald criteria (Thompson et al.
2017)
* **EDSS Score:** 0 to 6.5, inclusive
* **Childbearing Potential:**
* Women of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of <1% per year during the treatment period and for at least 6 months after the last dose of study treatment (per the USPI).
* Contraceptive methods include:
* Bilateral tubal ligation
* Male sterilization
* Established hormonal contraceptives that inhibit ovulation
* Hormone-releasing intrauterine devices
* Copper intrauterine devices
* The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient.
* Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
* **Eligible for Ocrelizumab:** Able to comply with the study protocol, in the investigator's judgment.
**Exclusion Criteria:**
* Experienced serious IRR(s)
* History of other neurological disorders that may interfere with the study
* History of severe allergic reactions to humanized or murine monoclonal antibodies
* Pregnancy or lactation
* Current or recent use of systemic corticosteroids or other immunosuppressants
* Known or suspected active infection requiring hospitalization or treatment with IV antibiotics within 4 weeks prior to baseline visit
* History of or current malignancy, including solid tumors and hematological malignancies, except for basal cell, in situ squamous cell carcinoma of the skin, and in situ carcinoma of the cervix of the uterus that have been excised with clear margins
* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
* History of alcohol or drug abuse within 24 weeks prior to enrollment
* Receipt of a live vaccine within 6 weeks prior to enrollment
* Systemic corticosteroid therapy within 4 weeks prior to enrollment
* Treatment with alemtuzumab
* Treatment with a B-cell targeted therapy other than ocrelizumab
* History of recurrent or chronic infection (e.g., HIV, syphilis, tuberculosis)
* History of severe autoimmune disorders that may interfere with the study
* History of severe heart failure
* History of pulmonary disease, including obstructive pulmonary disease
* History of renal disease, including renal failure
* History of hepatic disease, including liver failure
* History of endocrine disorders, including thyroid disease
* History of gastrointestinal disorders, including gastrointestinal bleeding
* History of cardiovascular disease, including arrhythmia
* History of gastrointestinal disorders, including gastrointestinal bleeding
* History of hematologic disorders, including anemia
* History of metabolic disorders, including diabetes mellitus
* History of psychiatric disorders, including psychosis
* History of other medical conditions that may interfere with the study
**Important Notes:**
* This is a summary of the modified eligibility criteria based on the provided text.
* The full protocol should be consulted for a complete and accurate understanding of the eligibility criteria.
* The specific inclusion and exclusion criteria may be subject to change based on the evolving understanding of the disease and the study design.
* It is crucial to consult with the study team and the relevant regulatory authorities for any specific questions or clarifications.