Glucocorticoid ResistanceNCT04601142
Association Between the Effect of Glucocorticoid Pulse Therapy on Neuromyelitis Optica (NMO) and Gene Polymorphism
An observational study of Glucocorticoid Resistance and Gene, run by Beijing Tongren Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Glucocorticoid Resistance, Gene, Neuromyelitis Optica
- What is being tested?
- Methylprednisolone
- How many people
- 350 participants
- Where
- 1 siteChina
- Study dates
- 31 Oct 2020to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: New diagnosis NMO patients who plan to receive methylprednisolone pulse therapy.
Who may be able to join
- Clinical diagnosis of neuromyelitis optica
- Chinese Han nationality, gender is unlimited;
- Must be able to accept methylprednisolone pulse therapy
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tongren Hospital
Beijing
Yu Yang Dai, PhD, 010-58268486 ext. 86, daiyy1991@163.com
About this study
Official title: 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.
- Conditions
- Glucocorticoid Resistance, Gene, Neuromyelitis Optica
- Being tested
- Methylprednisolone
- Medical subject headings
- Glucocorticoid Receptor Deficiency, Neuromyelitis Optica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methylprednisolone pulse therapy: 500-1000mg/d，３-５ｄ
| Study group | Role | What they receive |
|---|---|---|
| glucocorticoid sensitive (GS) group | Not described Receives: Drug: Methylprednisolone | |
| glucocorticoid resistance (GR) group | Not described Receives: Drug: Methylprednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change of best corrected visual acuity (BCVA)
Test BCVA before and after the treatment of methylprednisolone pulse therapy, and calculate the change value
Measured: 3 day after the treatment of methylprednisolone pulse therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start31 Oct 2020 (estimated)
- Primary completion30 Jun 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucocorticoid ResistanceStudies of the same condition, open and under way.
- More trials run by Beijing Tongren HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04601142
- Sponsor's protocol ID
- BeijingTH-YLJD-202001
- Status last verified
- Oct 2020
- First submitted
- 15 Oct 2020
- Last updated
- 23 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Association Between the Effect of Glucocorticoid Pulse Therapy on Neuromyelitis Optica and Gene Polymorphism: a Cohort Study
- ClinicalTrials.gov ID
- NCT04601142
- Acronym / sponsor ID
- BeijingTH-YLJD-202001
- Conditions
- Glucocorticoid Resistance, Gene, Neuromyelitis Optica
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 31 Oct 2020 (estimated)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 23 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| glucocorticoid sensitive (GS) group | – | Drug: Methylprednisolone |
| glucocorticoid resistance (GR) group | – | Drug: Methylprednisolone |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- New diagnosis NMO patients who plan to receive methylprednisolone pulse therapy.
Key inclusion criteria (3 listed)
- Clinical diagnosis of neuromyelitis optica
- Chinese Han nationality, gender is unlimited;
- Must be able to accept methylprednisolone pulse therapy
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methylprednisolonemethylprednisolone pulse therapy: 500-1000mg/d，３-５ｄ | Drug | glucocorticoid resistance (GR) group, glucocorticoid sensitive (GS) group |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glucocorticoid Resistance and Gene, run by Beijing Tongren Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu yang Dai, PhD (010-58268486 ext. 86, daiyy1991@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the change of best corrected visual acuity (BCVA) (time frame: 3 day after the treatment of methylprednisolone pulse therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2020.