JPRN-jRCT2051230006招募中1 期
Clinical pharmacology study of satralizumab in patients with anti-AQP4 antibody-positive neuromyelitis optica spectrum disorder (AQP4-IgG+NMOSD) to investigate pharmacodynamics-based pathogenetic mechanisms
Okuno Tatsusada0 个研究点目标入组 3 人开始时间: 2023年4月10日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 3
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
- 年龄范围
- >= 18age old 至 <= 74age old（—）
- 性别
- All
入选标准
- •At least 18 years old and less than 75 years old at the time of informed consent
- •Ability to understand and willingness to sign a written informed consent document and the study protocol
- •Confirmed diagnosis of developed new neurological symptoms due to NMOSD attacks
- •Meet the following diagnostic criteria for AQP4-IgG+NMOSD
- •1- At least one core clinical symptom*
- •2- Positive test for Anti-AQP4 antibody (in the case of recurrent patients, typical clinical symptoms that meet the diagnostic criteria and MRI findings during previous attacks allow the determination of anti-AQP4 antibody positivity based on previous anti-AQP4 antibody positivity)
- •3- Exclusion of alternative diagnoses
- •*Main Clinical Symptoms
- •- Optic neuritis
- •- Acute myelitis
- •- Area postrema syndrome : episode of otherwise unexplained hiccups or neusea and vomiting
- •- Acute brainstem syndrome
- •- Symptomatic narcolepsy or acute diencephalic clinical syndrome with NMOSD-typical diencephalic MRI lesions
- •- Symptomatic cerebral syndrome with NMOSD-typical brain MRI lesions
排除标准
- •Patients previously treated with IL-6 inhibitors, alemtuzumab, total-body radiation, or bone marrow transplant
- •Patients treated with CD20 inhibitors within 6 months prior to screening and B-cell fraction < 2.9%
- •Patients treated with eculizumab, belimumab, interferon (IFN), natalizumab, glatiramer acetate, fingolimod, teriflunomide, or dimethyl fumarate within 6 months before screening
- •Patients treated with CD4 inhibitors, cladribine, or mitoxantrone within 2 years prior to screening
- •Pregnant or breastfeeding women
- •Surgical procedures (excluding minor surgery) within 4 weeks prior to screening
- •Clinical evidence of other demyelinating diseases or progressive multifocal leukoencephalopathy
- •Patients with uncontrolled serious comorbidities that may preclude participation in the study
- •Active infection within 4 weeks prior to screening
- •Developed an infection requiring hospitalization or intravenous (IV) treatment within 4 weeks prior to screening
- •Active chronic hepatitis B or C
- •Bladder and rectal problems that are associated with urinary retention or urinary incontinence
- •History of diverticulitis, which, in the judgment of the physician, may increase the risk of complications such as perforation of the lower gastrointestinal tract
- •Patients with evidence of active tuberculosis (excluding patients receiving chemoprophylaxis for latent tuberculosis infection)
- •Patients with active interstitial lung disease
- •Receipt of live or live attenuated vaccine within 6 weeks prior to screening
研究者
相似试验
进行中（未招募）
3 期
A Study to Evaluate the Efficacy, Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Satralizumab in Participants With Anti-N-methyl-D-aspartic Acid Receptor (NMDAR) or Anti-leucine-rich Glioma-inactivated 1 (LGI1) EncephalitisNCT05503264Hoffmann-La Roche122
进行中（未招募）
1 期
PILOT STUDY ON THE USE OF SARILUMAB IN PATIENTS WITH COVID-19 INFECTIOPatients with COVID-19 infectionMedDRA version: 22.1Level: LLTClassification code 10048847Term: Lung infection NOSSystem Organ Class: 100000004862EUCTR2020-001745-40-ITASST FATEBENEFRATELLI SACCO40
进行中（未招募）
不适用
An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus MethotrexateMedDRA version: 17.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersRheumatoid ArthritisEUCTR2012-001984-66-DEsanofi-aventis Recherche & Développement5,910
进行中（未招募）
1 期
An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus MethotrexateMedDRA version: 15.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disordersRheumatoid ArthritisEUCTR2012-001984-66-GBsanofi-aventis Recherche & Développement776
进行中（未招募）
不适用
An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus MethotrexateRheumatoid ArthritisEUCTR2012-001984-66-GRsanofi-aventis Recherche & Développement5,910