azathioprine
DrugDose related to weigh (100 mg for weight ≤ 50 kg and 150 mg for weight > 50 kg) = 2 to 4 50mg oral caps, daily, during all the study period
NCT Number: NCT05349006
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 3
Department of Neurology, CHU de Bordeaux - GH Pellegrin, Bordeaux, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Dose related to weigh (100 mg for weight ≤ 50 kg and 150 mg for weight > 50 kg) = 2 to 4 50mg oral caps, daily, during all the study period
Dose related to weigh (100 mg for weight ≤ 50 kg and 150 mg for weight > 50 kg) = 2 to 4 50mg oral caps, daily, during all the study period
Time frame: During a randomized control period of a maximum of three years
A definite relapse will be defined as such:
As to ensure a maximum of homogeneity, we also propose a protocol-defined criteria for a MOGAD relapse, validated by the steering committee and available to every investigator (see Annex 2).
Time frame: : During a randomized control period of a maximum of three years
Time frame: at baseline and at 36 months
Global disability at 36 months assessed by EDSS: The EDSS scale is a method of quantifying disability and monitoring changes in the level of disability over time. It is widely used in clinical trials and in the assessment of patients with inflammatory disorders of the central nervous system. The EDSS scale ranges from 0 to 10 in 0.5-unit increments (20 values) that represent higher levels of disability. Scoring is based on an examination by a neurologist.
Time frame: at baseline and at 36 months
Worsening from baseline to 36 months of the EDSS
Time frame: at baseline and at 36 months
Ambulation status at 36 months assessed by the Ambulation Score. Scoring is based on a measurement of the distance the patient is able to walk (in meters) and then classified in 12 levels.
Time frame: at baseline and at 36 months
Worsening from baseline to 36 months of the Ambulation Score.
Time frame: at baseline and at 36 months
Best-corrected high contrast visual acuity at 36 months measured (each eye tested separately) using the standard Snellen chart or equivalent.
Time frame: at baseline and at 36 months
Worsening from baseline to 36 months of visual disability assessed by change of the best- corrected high-contrast visual acuity using the standard Snellen chart or equivalent (each eye tested separately).
Time frame: at baseline and at 36 months
Best-corrected low-contrast visual acuity at 36 months using the Sloan Charts at 2.5%, in each eye.
Time frame: at baseline and at 36 months
Worsening from baseline to 36 months of low-contrast visual acuity using the Sloan Charts at 2.5%, in each eye.
Time frame: at baseline and at 36 months
Inner retinal layers thicknesses at 36 months assessed by the spectral domain OCT (each eye tested separately)
Time frame: at baseline and at 36 months
Worsening from baseline to 36 months of the peripapillary retinal nerve fiber layer thickness (μm) and the ganglion cell complex thickness (μm) assessed with spectral domain OCT (each eye tested separately).
Time frame: at 36 months
https://euroqol.org
Time frame: During a randomized control period of a maximum of three years
percentage of untaken pills (left in the blisters) regarding each patient
Time frame: at baseline and at 36 months
Description, and comparison between the two groups, of worsening of MRI (brain and spinal cord and visual) from baseline to 36 months assessed by number of new/enlarging T2 lesions
Time frame: at baseline and at 36 months
Description and comparison between the two groups of worsening of MRI (brain and/or spinal cord and/or visual) from baseline to 36 months assessed by number of new T1 gadolinium enhancing lesions
Time frame: at screening, at 6 months, at 12 months, at 36 months and in case of a relapse
In each group of treatment, association between MOG-Ab titer at first episode and the risk of relapse
Time frame: at screening, at 6 months, at 12 months, at 36 months and in case of a relapse
In each group of treatment, association between MOG-Ab titer at onset and the level of global disability assessed by the EDSS at 36 months.
Time frame: at screening, at 6 months, at 12 months, at 36 months and in case of a relapse
In each group of treatment, prognostic value of longitudinal MOG-Ab-titers to predict relapse.
Contact information is provided by the study sponsor or research team.
Lakhdar BENYAHYA, project manager
CONTACT
Romain MARIGNIER, MD PhD
CONTACT
Hospices Civils de Lyon
Other
A Randomized, Placebo-controlled Phase 3 Trial of Azathioprine for the Prevention of Relapse in Myelin-oligodendrocyte-glycoprotein (MOG)-Antibody Associated Disease
Acronym: MOGwAI
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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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