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Completed

NCT Number: NCT05896605

Monitoring of Azathioprine Metabolite Concentrations and Cytokine Levels in Neuromyelitis Optica Spectrum Disorder

Background: The pathogenesis of NMOSD has been linked to the cytokines interleukins (IL) -6, NOD-, LRR-and pyrin domain-containing 3 (NLRP3) and IL-18 that contribute to development of inflammatory reactionsmay. Although azathioprine (AZA) is efficacious in preventing NMOSD recurrence, it may have adverse effects (AEs) maybe related to the plasma concentrations.

Objective: We would monitor the blood concentrations of AZA in NMOSD, and their relationship with cytokines, severity, efficacy, and safety range of the drug.

Methods: A total of 53 NMOSD patients were included in the study, which included 20 patients who had received AZA treatment within 1 month, and 16 patients who had received AZA treatment within 6 months, as well as 17 patients who had received AZA treatment at least 12 months. The patient's immunotherapy regimen was low-dose hormone combined with AZA. AZA was started at small doses and added every two weeks after no AEs, namely 50 mg qd for two weeks, 50mg bid for two weeks, and maintained at 50mg tid. The following clinical data were collected: gender, age, clinical symptoms, EDSS score, number of recurrences and AEs, etc. Healthy controls (HC) comprised 10 individuals. AZA metabolite concentrations 6-thioguaninenucleotides (6-TGN) and 6-methylmercaptopurine nucleotides (6-MMPN) were measured by High-performance liquid chromatography (HPLC). Levels of IL-6, NLRP3 and IL-18 were measured by Enzyme-linked immunosorbent assay (ELISA).

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Key information

Conditions

NMO Spectrum Disorder Autoimmune Diseases Autoimmune Diseases of the Nervous System Azathioprine Adverse Reaction Cranial Nerve Diseases Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Eye Diseases Immune System Diseases Myelitis, Transverse Nervous System Diseases Neuromyelitis Optica Optic Nerve Diseases Optic Neuritis

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Qingmeng Huang

Nanning, Guangxi, 530021, China

About this study

A total of 53 NMOSD patients were recruited from Neurology Department of the First Affiliated Hospital of Guangxi Medical University.According to the duration of AZA treatment, 20 patients were divided into 1 month after AZA treatment, 16 patients in 6 months after AZA treatment and 17 patients over 12 months after AZA treatment. Clinical data of patients were collected, including: gender, age, time of first onset, time of medication, clinical symptoms, number of recurrence, EDSS score, serum and cerebrospinal fluid AQP 4-IgG titers, imaging results, rheumatic immunity-related autoimmune antibodies, comorbidities, related adverse drug reactions, etc. Ten healthy volunteers with physical examination in our hospital were selected as the healthy control (HC) group.Blood (5ml) was collected from peripheral veins of patients and healthy volunteers.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All patients with NMOSD met the international consensus diagnostic criteria for NMOSD published in 2015. Before medication, TPMT activity was normal.

Exclusion criteria

Patients with fever, infection, or patients with other autoimmune diseases, uncontrolled malignancies, and other chronic diseases were excluded.

Treatment and study plan

azathioprine

Drug

Before medication, TPMT activity was normal, and AZA was started at small doses and added every two weeks after no AEs, namely 50 mg qd for two weeks, 50mg bid for two weeks, and maintained at 50mg tid.

Other names: Azathioprine Tablets

Primary outcomes

  1. The concentrations of 6-TGN and 6-MMPN in NMOSD patients

    Time frame: 1 month

    The mean 6-TGN concentrations and 6-MMPN concentrations in 1 month after AZA treatment were tested by HPLC

  2. The concentrations of 6-TGN and 6-MMPN in NMOSD patients

    Time frame: 6 months

    The mean 6-TGN concentrations and 6-MMPN concentrations in 6 months after AZA treatment were tested by HPLC.

  3. The concentrations of 6-TGN and 6-MMPN in NMOSD patients

    Time frame: 12 months

    The mean 6-TGN concentrations and 6-MMPN concentrations in over 12 months after AZA treatment were tested by HPLC.

  4. Serum levels of IL-6, NLRP3 and IL-18 in NMOSD patients and HC

    Time frame: 1 month

    The levels of IL-6, IL-18, and NLRP 3 inflammasome were measured in the enzyme-linked immunoassay kit.

  5. Serum levels of IL-6, NLRP3 and IL-18 in NMOSD patients and HC

    Time frame: 6 months

    The levels of IL-6, IL-18, and NLRP 3 inflammasome were measured in the enzyme-linked immunoassay kit.

  6. Serum levels of IL-6, NLRP3 and IL-18 in NMOSD patients and HC

    Time frame: 12 months

    The levels of IL-6, IL-18, and NLRP 3 inflammasome were measured in the enzyme-linked immunoassay kit.

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Guangxi Medical University

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Jun 9, 2023
Registry last updated
Jun 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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