RecruitingPhase 3MOGADNCT053490062022-500520-30-00

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Azathioprine

    Amidophosphoribosyltransferase inhibitor|DNA inhibitor

Placebo or sham

  • Placebo
  • Hydrogénophosphate de calcium dihydraté : Fournisseur Brenntag

What it measured

Main measures

  • Time to first relapse (in days), comparing azathioprine-treated vs placebo-treated patients during a randomized control period of a maximum of three years.

    During a randomized control period of a maximum of three years

    Relapses

Other measures (10)

  • Number and type of adverse events, including serious adverse events, related to azathioprine and/or steroids and placebo

    : During a randomized control period of a maximum of three years

    Safety
  • Evaluation of global disability at 36 months

    at baseline and at 36 months

    Disability progressionWalking and mobility
  • Evaluation of visual disability at 36 months

    at baseline and at 36 months

    VisionRetina scans (OCT)
  • Quality of life will be assessed using the EuroQOL EQ-5D-3L at 36 months

    at 36 months

    Quality of life (reported by participants)
  • Compliance to treatment

    During a randomized control period of a maximum of three years

  • Exploratory radiological features

    at baseline and at 36 months

    MRI lesions
  • Exploratory biological features

    at screening, at 6 months, at 12 months, at 36 months and in case of a relapse

    RelapsesDisability progression
  • • Global disability at M36 assessed by EDSS (Expanded Disability Status Scale) • Worsening from baseline to M36 of the EDSS • Ambulation status at M36 assessed by the Ambulation Score based on a measurement of the distance the patient is able to walk. • Worsening from baseline to M36 of the Ambulation Score.

    Disability progressionWalking and mobility
  • • Best-corrected high contrast visual acuity at M36 measured using the standard Snellen chart or equivalent. • Worsening from baseline to M36 of visual disability assessed by change of the best- corrected high-contrast visual acuity using the standard Snellen chart or equivalent. • Best-corrected low-contrast visual acuity at M36 using the Sloan Charts at 2.5%, in each eye. • Worsening from basel

    Vision
  • Compliance to treatment will be described in both arms by the percentage of untaken tablets (left in the blisters) regarding each patient’s time of participation in the study.

Who could take part

MOGAD · 18 and over

Inclusion Criteria: * Age ≥ 18 years * First attack of documented acute demyelinating syndrome of the central nervous system, within the past 3 months, whatever the severity or the clinical phenotype * Tested positive for MOG-Ab, confirmed in a centralized lab (Lyon referral centre) * Ability of the subject to understand the purpose and risks of the study and provide signed and dated written informed consent. * Patients should be beneficiary of health care coverage under the social security system * Female patients of childbearing potential should have effective contraception throughout the course of treatment and for at least three months after stopping treatment. Exclusion Criteria: * Hypersensitivity to azathioprine or steroids * Active infections or cancer (including tuberculosis, hepatitis, herpes and VZV) * Psychosis not controlled by treatment * Seriously impaired bone marrow functions: Lymphocyte count \< 1000/ml and or Polynuclear neutrophil count \< 1500/ml * Seriously impaired hepatic functions: ALT and/or AST > 3N * Seriously impaired renal functions: GFR \< 29 ml/min/1.73m² * Any live vaccine in the past 3 months or planned during the RCT and RCT+6months * Thiopurine methyltransferase (TPMT) phenotype deficient or intermediate, with enzymatic activity \< 16 nmol/h/ml * Unable to complete an MRI (e.g. due to pacemaker, severe claustrophobia, hypersensitivity to contrast media, or who lack adequate peripheral venous access) * Necessary use of a xanthine oxidase inhibitor (Allopurinol, Oxipurinol, Thiopurinol, Febuxotat,…) * Necessary use of angiotensin-converting-enzyme inhibitor, cotrimoxazole, cimetidine and indometacine * Necessary use of an aminosalicylate derivates * Necessary use of any another immunosuppressive therapy, different than azathioprine, or steroids * Necessary use of cytotoxic therapy * Necessary use of any other medical illness or disability that, in the opinion of the investigator, would compromise effective trial participation * Current enrollment or a plan to enroll in any interventional clinical study in which an investigational treatment or approved therapy is use within 5 half-lives prior to baseline. Participation in a non- interventional study can be allowed as long as this participation does not interfere with this protocol or is not likely to affect the subject's ability to comply with the protocol. * For subjects coming back from strongyloidiasis endemic regions, a parasitology screening examination will be performed on faeces, and that appropriate treatment will be performed prior to administration of corticosteroids * Patients with Lesch Nyhan syndrome * Asian patients (probable mutation of the gene NUDT1) * Female subjects who have a positive a positive urinary or blood pregnancy test result, are pregnant or are currently breast feeding * Inability to comply with study requirements * Person under legal protection or deprived of liberty

As registered. Criteria can change, so ask the trial team or your neurologist.

Contact details on the registry

About this trial

In the sponsor's words

MOG-IgG associated disease (MOGAD) is a rare inflammatory disease of the central nervous system recently described. Initially reported as monophasic, data from incident cohorts suggests that around 50% of adult patients with MOG-Ab may relapse within the first two years of the disease, with most of relapses occurring early after disease onset. No randomized controlled trial has ever been performed and therapeutic guidelines for this disease remain unclear especially after a single event. In short-sized and mainly retrospective study, azathioprine, an immunosuppressant drug, have showed promising results on preventing the risk of relapse in MOGAD patients. The hypothesis is that the initiation of a treatment after a first attack of MOGAD should prevent further relapse and disability accrual. The investigators propose herein the first randomized controlled trial in MOGAD, to evaluate the efficacy of azathioprine to prevent relapses, after a first attack, in a placebo double-blinded design.

Papers

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    History

      1. Started

        Dec 2023

      2. Main results due

        Dec 2026

      3. Finished

        Dec 2029

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