PER-068-20尚未招募未知
A PHASE IIIB MULTICENTER, RANDOMIZED,DOUBLE-BLIND, CONTROLLED STUDY TOEVALUATE THE EFFICACY, SAFETY ANDPHARMACOKINETICS OF A HIGHER DOSE OFOCRELIZUMAB IN ADULTS WITH PRIMARYPROGRESSIVE MULTIPLE SCLEROSIS
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Patients must meet the following criteria for study entry:
- •- Signed ICF
- •- Ages 18- 55 years at time of screening
- •- Ability to comply with the study protocol
- •- Diagnosis of PPMS, in accordance with the revised McDonald criteria 2017 (Thompson
- •et al. 2018)
- •- EDSS score at screening and baseline
- •- Score of 2.0 on the Functional Systems (FS) scale for the pyramidal system
- •- Patients requiring symptomatic treatment for MS (e.g., fampridine, cannabis) and/or
- •physiotherapy must be treated at a stable dose during the screening period prior to the
- •initiation of study drug on Day 1 and must have a plan to remain at a stable dose for the
- •duration of study treatment
- •- Patients must be neurologically stable for at least 30 days prior to randomization and
- •baseline assessments
- •- Disease duration from the onset of MS
- •- Documented evidence of the presence of cerebrospinal fluid-specific oligoclonal bands
- •(established by a historical lumbar puncture or presence at screening in a newly obtained
- •CSF specimen (source documentation of historical laboratory results and method must be
- •- For women of childbearing potential: agreement to remain abstinent (refrain from
- •heterosexual intercourse) or use adequate contraceptive methods during the treatment
- •period and for 6 or 12 months (as applicable by the ocrelizumab [Ocrevus] local label) after
- •the final dose of ocrelizumab.
- •- For female patients without reproductive potential. Females may be enrolled if post-menopausal (i.e., spontaneous amenorrhea for the past year confirmed by a follicle-stimulating hormone [FSH] level 40 mIU/mL) unless the patient is receiving a hormonal therapy for her menopause or if surgically sterile (i.e., hysterectomy, complete bilateral oophorectomy).
- •For more details, review the protocol.
排除标准
- •Patients who meet any of the following criteria will be excluded from study entry:
- •- History of relapsing remitting or secondary progressive MS at screening
- •- Any known or suspected active infection at screening or baseline (except nailbed
- •infections), or any major episode of infection requiring hospitalization or treatment with IV
- •anti microbials within 8 weeks prior to and during screening or treatment with oral anti
- •microbials within 2 weeks prior to and during screening
- •- History of confirmed or suspected progressive multifocal leukoencephalopathy (PML)
- •- History of cancer
- •- Immunocompromised state
- •- Receipt of a live or live-attenuated vaccine within 6 weeks prior to randomization.
- •- Inability to complete an MRI
- •- Contraindications to mandatory pre-medications (i.e., corticosteroids and antihistamines) for
- •IRRs, including uncontrolled psychosis for corticosteroids or closed-angle glaucoma for
- •antihistamines
- •- Known presence of other neurologic disorders
- •- Any concomitant disease that may require chronic treatment with systemic corticosteroids
- •or immunosuppressants during the course of the study
- •- Significant, uncontrolled disease, such as cardiovascular (including cardiac arrhythmia),
- •pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine or
- •gastrointestinal, or any other significant disease that may preclude patient from participating
- •in the study.
- •For more details, review the protocol.
研究者
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A PHASE IIIB MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACOKINETICS OF A HIGHER DOSE OF OCRELIZUMAB IN ADULTS WITH RELAPSING MULTIPLE SCLEROSIS-G35 Multiple sclerosisG35Multiple sclerosisPER-056-20F. HOFFMANN-LA ROCHE LTD.,
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