Neuromyelitis optica spectrum disorder
Conditions
Interventions
Case group:Orelabrutinib, orally, 50 mg QD
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The age at the time of signing the informed consent is 18-75 years old (including 18 and 75 years old); 2. According to the 2015 IPND diagnostic criteria, it was diagnosed as AQP4 IgG positive NMOSD; 3. There were = 2 relapses within 1 year before screening, and at least one relapse occurred within 6 months before screening; 4. If the subject has stable hormone treatment (= 7.5 mg prednisone, or the equivalent dose of hormone), the stable treatment should be more than 1 month before starting the study drug treatment; 5. Extended disability status score (EDSS) = 7.5 during screening; 6. The serum pregnancy test was negative when women with fertility were screened; 7. Understand the research procedure and sign the written informed consent voluntarily.
Exclusion criteria
Exclusion criteria: 1. History of serious heart, lung, liver, kidney and blood diseases; 2. Any major infection occurred in hospital or requiring parenteral antibacterial treatment and judged by the investigator one month before screening; 3. Have had = 2 episodes of herpes zoster or had a history of disseminated herpes zoster; 4. Being taking or having any of the following medication/treatment history: 1) Have received BTK inhibitors at any time in the past; 2) Within 12 weeks before the first administration, he received B cell targeted therapy; 3) Have received biological agents within 12 weeks before the first administration; 4) Receive live virus vaccine or attenuated live vaccine within 8 weeks before the first administration; 5) Within 6 months before screening, patients received hormone therapy for other diseases, and the dose was>20mg/day;> 21 days; 6) One investigational drug or other experimental treatment was used within 4 weeks and 5 pharmacokinetic half lives before screening, or is participating in any other intervention clinical trial. 5. When screening or baseline inspection, relevant laboratory inspection results meet the exclusion criteria: HIV: Human immunodeficiency virus (HIV) is positive; HCV: hepatitis C virus (HCV) antibody is positive (if the participant has a history of HCV infection, has completed and recorded appropriate treatment at least one year before screening, and the HCV RNA measured by PCR is negative during screening, the participant will not be excluded from this study); HBsAg/HBcAb: HBsAg positive and/or HBcAb positive; Renal function: estimated glomerular filtration rate (eGFR)2 x ULN, total bilirubin>1.5 x ULN, or any other clinically significant laboratory abnormality; Hematopenia: neutrophil count<1500/mm3, platelet count<75000/mm3, lymphocyte count<1000/mm3 or white blood cell count<3500/mm3; Coagulation function: International standardized ratio (INR) = 1.5 or activated partial thromboplastin time (APTT) = 1.5x ULN; B cells: the CD19 count of B cells was lower than the lower limit of the normal range; 6. Have used strong to moderate CYP3A inducers within 3 weeks before treatment, or have used strong to moderate CYP3A inhibitors within 1 week before treatment, or may use strong to moderate CYP3A inducers or inhibitors at the same time during treatment; 7. There are situations that other researchers think are not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary indicator; | — |
Secondary
| Measure | Time frame |
|---|---|
| validity index;validity index;validity index;validity index;validity index;validity index;Security Index; | — |
Countries
China
Contacts
Public ContactYan Xu
Peking Union Medical College Hospital
Outcome results
None listed