BridgeMD
New treatment option for Central Nervous System Inflammation
Official title Azathioprine in MOGAD
ClinicalTrials.gov ID: NCT05349006
What this study is testing
What is Azathioprine?
Azathioprine is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for central nervous system inflammation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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
You likely can't join if
- 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
See the full eligibility 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.
- 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 treatment clinical study in which an investigational treatment or approved therapy is use within 5 half-lives prior to baseline. Participation in a non- treatment study can...
- For people 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 people 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
The study team makes the final eligibility decision.
Where it's taking place
- Bordeaux, France
- Lille, France
- Lyon, France
- Marseille, France
- Montpellier, France
- Nancy, France
- Nice, France
- Nîmes, France
- Paris, France
- Rennes, France
- Rouen, France
- Saint-Herblain, France
- Strasbourg, France
- Toulouse, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bordeaux, France; Lille, France; Lyon, France; Marseille, France; Montpellier, France; Nancy, France and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.