Association Between the Effect of Glucocorticoid Pulse Therapy on Neuromyelitis Optica (NMO) and Gene Polymorphism

Neuromyelitis Optica Clinical Trial

Official title:

Study on the Association Between the Effect of Glucocorticoid Pulse Therapy on Neuromyelitis Optica and Gene Polymorphism: a Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04601142
• Other study ID #: BeijingTH-YLJD-202001
• Status: Recruiting
• Start date: October 31, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: October 2020
• Source: Beijing Tongren Hospital
• Contact: Yu yang Dai, PhD
• Phone: 010-58268486
• Email: daiyy1991[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Aims of this study are to observe the correlation between ABCB1、VDR、TBX21、NR3C1 and other gene polymorphisms and the effect of glucocorticoid shock therapy on neuromyelitis optica. Investigators plan to include patients with neuromyelitis optica who will receive glucocorticoid shock therapy prospectively. The patients are divided into glucocorticoid sensitive (GS) group and glucocorticoid resistance (GR) group according to the change of central vision after treatment. Patients' clinical data will be collected and blood samples are needed for single nucleotide polymorphism (SNP) typing test. Through statistical analysis, the data differences between GS group and GR group were compared, and the effects of clinical indexes and gene polymorphisms on the efficacy of glucocorticoid shock therapy in the treatment of neuromyelitis optica should be analyzed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: December 31, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 80 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of neuromyelitis optica

• Chinese Han nationality, gender is unlimited;

• Must be able to accept methylprednisolone pulse therapy

Exclusion Criteria:

• Other optic nerve diseases, such as ischemic, compressive, invasive, traumatic, toxic and nutritional metabolic, hereditary optic neuropathy;

• Visual path and central lesion on optic chiasma;

• Other eye diseases, such as anterior segment lesions, retinopathy, macular lesions, ametropia, glaucoma, etc;

• Non-organic visual impairment;

• Treated with glucocorticoid in two weeks.

Related Conditions & MeSH terms

• Gene
• Glucocorticoid Resistance
• Neuromyelitis Optica

Intervention

Drug:
• Methylprednisolone
methylprednisolone pulse therapy: 500-1000mg/d,3-5d

Locations

Country	Name	City	State
China	Beijing Tongren Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tongren Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the change of best corrected visual acuity (BCVA)	Test BCVA before and after the treatment of methylprednisolone pulse therapy, and calculate the change value	3 day after the treatment of methylprednisolone pulse therapy