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

NCT04601142 | Unknown

• 1 other identifier: BeijingTH-YLJD-202001
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Glucocorticoid Resistance; Gene; Neuromyelitis Optica

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

glucocorticoid sensitive (GS) group

Drug: Methylprednisolone

glucocorticoid resistance (GR) group

Drug: Methylprednisolone

Interventions

Methylprednisolone DRUG

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

glucocorticoid resistance (GR) group; glucocorticoid sensitive (GS) group

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

New diagnosis NMO patients who plan to receive methylprednisolone pulse therapy.

You may qualify if:

• Clinical diagnosis of neuromyelitis optica
• Chinese Han nationality, gender is unlimited;
• Must be able to accept methylprednisolone pulse therapy

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tongren Hospital: lead

Study Sites (1)

Beijing Tongren Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Glucocorticoid Receptor Deficiency; Neuromyelitis Optica

Interventions

Methylprednisolone

Condition Hierarchy (Ancestors)

Myelitis, Transverse; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Optic Neuritis; Optic Nerve Diseases; Cranial Nerve Diseases; Demyelinating Diseases; Eye Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Yu yang Dai, PhD

CONTACT

010-58268486; daiyy1991@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: October 23, 2020
• Study Start: October 31, 2020
• Primary Completion: June 30, 2021
• Study Completion: December 31, 2021
• Last Updated: October 23, 2020

Record last verified: 2020-10

Locations

CN (1)