Clinical and Imaging Cohort of Neuroinflammation Diseases in China (CLUE)

NCT04106830 | Recruiting DMC

• 1 other identifier: KY2024-309-04
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

CLUE is a prospective study to determine structural and functional changes of brain and spinal cord, as well as the inflammatory environment in patients with neuroinflammatory and demyelination disease. Participants will receive new magnetic resonance (MR) technics including double inversion recovery (DIR) imaging diffusion kurtosis imaging (DKI), quantitative susceptibility mapping (QSM) and resting-state functional imaging and follow up for one year using 3T MRI. In addition, participants will receive T1WI, T2WI, FLAIR and SWI sequences on 7T MRI.

Conditions

NMO Spectrum Disorder; MRI; Multiple Sclerosis; MOGAD

Outcome Measures

Primary Outcomes (3)

• The brain structural change over time between the baseline MRI and the follow-up MRIs

  To describe changes of lesions, grey matter and white matter in patients with neuroinflammatory and demyelination disease measured by DIR and QSM. The primary endpoint is the change over time between the baseline MRI and the follow-up MRIs, of the lesions and brain volumes.

  On admission to the hospital on day 1, on discharge 180 days later and on follow up 360 days later

• The spinal cord change over time between the baseline MRI and the follow-up MRIs.

  To describe changes of lesions and integrity of fiber bundle in spinal cord in neuroinflammatory and demyelination disease patients measured by DKI. The primary endpoint is the change over time between the baseline MRI and the follow-up MRIs, of structural change in spinal cord.

  On admission to the hospital on day 1, on discharge 180 days later and on follow up 360 days later

• The functional change over time between the baseline MRI and the follow-up MRIs.

  To describe brain functional changes in patients with neuroinflammatory and demyelination disease measured by resting-state functional imaging. The primary endpoint is the functional change over time between the baseline MRI and the follow-up MRIs

  On admission to the hospital on day 1, on discharge 180 days later and on follow up 360 days later

Secondary Outcomes (3)

• Change from Baseline Expanded Disability Status Scale （EDSS）/ Functional Systems （FS）

  On admission to the hospital on day 1, on discharge 180 days later and on follow up 360 days later

• Timed 25-foot Walk

  On admission to the hospital on day 1, on discharge 180 days later and on follow up 360 days later

• Mean change in visual acuity as assessed by Sloan 2.5% low contrast visual acuity chart.

  On admission to the hospital on day 1, on discharge 180 days later and on follow up 360 days later

Study Arms (4)

NMOSD

Patients with neuromyelitis optica spectrum disorders

Drug: Intravenous steroid

Multiple sclerosis(MS)

Patients with multiple sclerosis

Drug: Intravenous steroid

MOGAD

Patients with myelin oligodendrocyte glycoprotein antibody-associated disease

Drug: Intravenous steroid

Healthy controls (HC)

Healthy people without any neuroinflammation disease

Interventions

Intravenous steroid DRUG

This study does not limit treatment methods.patients commonly use high-dose intravenous steroid therapy (HD-S) during acute stage. The HD-S treatment course referred to intravenous administration of 1 g of glucocorticoid daily for 3 consecutive days and continuous dose 240 mg reduction for 60mg oral administration. Immunomodulatory therapies are necessary for the remission stage. The treatment methods include: Azathioprine (start at 50 mg per day, add 50 mg per week to 2 mg/kg.d); Mycophenolate Mofetil (The initial dose was 0.25g bid, add 0.5g per week to 0.75g bid); and Rituximab (500 mg on the 1st day, the 15th day, then 500mg per half year).

Also known as: Azathioprine, Mycophenolate Mofetil, Rituximab

MOGAD; Multiple sclerosis(MS); NMOSD

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

To reflect the daily practices, this study includes all patients with neuroinflammatory and demyelination disease at the beginning of the study.

You may qualify if:

• Diagnosis of neuroinflammatory and demyelination disease
• Availability of demographic and clinical data at the time disease onset
• Informed written consent obtained from the patient, and/or patient's parent(s), and/or legal representative. Assent, if old enough to grant, will be obtained from all patients under the age of 16 years.

You may not qualify if:

• Patients for whom MRI is contra-indicated
• Patients included in an ongoing clinical trial where the product is blinded

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100053, China

RECRUITING

Related Publications (1)

• Xu Y, Ren Y, Li X, Xu W, Wang X, Duan Y, Liu Y, Zhang X, Tian DC. Persistently Gadolinium-Enhancing Lesion Is a Predictor of Poor Prognosis in NMOSD Attack: a Clinical Trial. Neurotherapeutics. 2021 Apr;18(2):868-877. doi: 10.1007/s13311-020-00973-9. Epub 2021 Jan 19.

  PMID: 33469828 DERIVED

MeSH Terms

Conditions

Neuromyelitis Optica; Multiple Sclerosis; Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease

Interventions

Azathioprine; Mycophenolic Acid; Rituximab

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)

Thionucleosides; Sulfur Compounds; Organic Chemicals; Mercaptopurine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Caproates; Acids, Acyclic; Carboxylic Acids; Fatty Acids; Lipids; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Yaou Liu, PhD

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yaou Liu, PhD

CONTACT

+86 1059975396; yaouliu80@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 25, 2019
• First Posted: September 27, 2019
• Study Start: January 1, 2019
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2028
• Last Updated: December 24, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Within 5 years after the end of the trial.
• Access Criteria: Neurologist and radiologist who submitting an application to Prof. Liu.

Locations

CN (1)