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

NCT ID: NCT04601142

Last Updated: 2020-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-31

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Glucocorticoid Resistance Gene Neuromyelitis Optica

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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glucocorticoid sensitive (GS) group

Methylprednisolone

Intervention Type DRUG

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

glucocorticoid resistance (GR) group

Methylprednisolone

Intervention Type DRUG

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

Interventions

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Methylprednisolone

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Tongren Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Beijing Tongren Hospital

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yu yang Dai, PhD

Role: CONTACT

[email protected]
010-58268486 ext. 86

Facility Contacts

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Yu Yang Dai, PhD

Role: primary

[email protected]
010-58268486 ext. 86

Other Identifiers

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BeijingTH-YLJD-202001

Identifier Type: -

Identifier Source: org_study_id