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

October 22, 2020 updated by: Beijing Tongren Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Beijing Tongren Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 80 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
glucocorticoid sensitive (GS) group
Drug: Methylprednisolone
methylprednisolone pulse therapy: 500-1000mg/d，３-５ｄ
glucocorticoid resistance (GR) group
Drug: Methylprednisolone
methylprednisolone pulse therapy: 500-1000mg/d，３-５ｄ

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the change of best corrected visual acuity (BCVA)
Time Frame: 3 day after the treatment of methylprednisolone pulse therapy
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tongren Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

October 31, 2020

Primary Completion (ANTICIPATED)

June 30, 2021

Study Completion (ANTICIPATED)

December 31, 2021

Study Registration Dates

First Submitted

October 15, 2020

First Submitted That Met QC Criteria

October 22, 2020

First Posted (ACTUAL)

October 23, 2020

Study Record Updates

Last Update Posted (ACTUAL)

October 23, 2020

Last Update Submitted That Met QC Criteria

October 22, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BeijingTH-YLJD-202001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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