Ignite Creation Date:
2025-12-26 @ 4:02 PM
Ignite Modification Date:
2025-12-26 @ 4:02 PM
Study NCT ID:
NCT05349006
Status:
RECRUITING
Last Update Posted:
2025-02-04
First Post:
2022-04-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Azathioprine in MOGAD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000098542', 'term': 'Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease'}, {'id': 'D009902', 'term': 'Optic Neuritis'}, {'id': 'D009187', 'term': 'Myelitis'}, {'id': 'D009471', 'term': 'Neuromyelitis Optica'}], 'ancestors': [{'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D009901', 'term': 'Optic Nerve Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D009188', 'term': 'Myelitis, Transverse'}, {'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001379', 'term': 'Azathioprine'}], 'ancestors': [{'id': 'D013872', 'term': 'Thionucleosides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D015122', 'term': 'Mercaptopurine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'double blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 126}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2029-12-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-31', 'studyFirstSubmitDate': '2022-04-15', 'studyFirstSubmitQcDate': '2022-04-21', 'lastUpdatePostDateStruct': {'date': '2025-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to first relapse (in days), comparing azathioprine-treated vs placebo-treated patients during a randomized control period of a maximum of three years.', 'timeFrame': 'During a randomized control period of a maximum of three years', 'description': 'A definite relapse will be defined as such:\n\n* When a patient is diagnosed as experiencing a relapse by the local investigator, the anonymized file will be reviewed within 4 days by a second investigator neurologist, not aware of the randomization group nor of the center treating the patient.\n* If this second neurologist also considers the patient as experiencing a relapse, the patient will be considered as relapsing for the main analysis.\n* If the second neurologist disagrees, the opinion of a third neurologist will be asked and the majority opinion will be retained.\n\nAs 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).'}], 'secondaryOutcomes': [{'measure': 'Number and type of adverse events, including serious adverse events, related to azathioprine and/or steroids and placebo', 'timeFrame': ': During a randomized control period of a maximum of three years'}, {'measure': 'Evaluation of global disability at 36 months', 'timeFrame': 'at baseline and at 36 months', 'description': '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.'}, {'measure': 'Evaluation of global disability at 36 months', 'timeFrame': 'at baseline and at 36 months', 'description': 'Worsening from baseline to 36 months of the EDSS'}, {'measure': 'Evaluation of global disability at 36 months', 'timeFrame': 'at baseline and at 36 months', 'description': '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.'}, {'measure': 'Evaluation of global disability at 36 months', 'timeFrame': 'at baseline and at 36 months', 'description': 'Worsening from baseline to 36 months of the Ambulation Score.'}, {'measure': 'Evaluation of visual disability at 36 months', 'timeFrame': 'at baseline and at 36 months', 'description': 'Best-corrected high contrast visual acuity at 36 months measured (each eye tested separately) using the standard Snellen chart or equivalent.'}, {'measure': 'Evaluation of visual disability at 36 months', 'timeFrame': 'at baseline and at 36 months', 'description': '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).'}, {'measure': 'Evaluation of visual disability at 36 months', 'timeFrame': 'at baseline and at 36 months', 'description': 'Best-corrected low-contrast visual acuity at 36 months using the Sloan Charts at 2.5%, in each eye.'}, {'measure': 'Evaluation of visual disability at 36 months', 'timeFrame': 'at baseline and at 36 months', 'description': 'Worsening from baseline to 36 months of low-contrast visual acuity using the Sloan Charts at 2.5%, in each eye.'}, {'measure': 'Evaluation of visual disability at 36 months', 'timeFrame': 'at baseline and at 36 months', 'description': 'Inner retinal layers thicknesses at 36 months assessed by the spectral domain OCT (each eye tested separately)'}, {'measure': 'Evaluation of visual disability at 36 months', 'timeFrame': 'at baseline and at 36 months', 'description': '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).'}, {'measure': 'Quality of life will be assessed using the EuroQOL EQ-5D-3L at 36 months', 'timeFrame': 'at 36 months', 'description': 'https://euroqol.org'}, {'measure': 'Compliance to treatment', 'timeFrame': 'During a randomized control period of a maximum of three years', 'description': 'percentage of untaken pills (left in the blisters) regarding each patient'}, {'measure': 'Exploratory radiological features', 'timeFrame': 'at baseline and at 36 months', 'description': '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'}, {'measure': 'Exploratory radiological features', 'timeFrame': 'at baseline and at 36 months', 'description': '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'}, {'measure': 'Exploratory biological features', 'timeFrame': 'at screening, at 6 months, at 12 months, at 36 months and in case of a relapse', 'description': 'In each group of treatment, association between MOG-Ab titer at first episode and the risk of relapse'}, {'measure': 'Exploratory biological features', 'timeFrame': 'at screening, at 6 months, at 12 months, at 36 months and in case of a relapse', 'description': '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.'}, {'measure': 'Exploratory biological features', 'timeFrame': 'at screening, at 6 months, at 12 months, at 36 months and in case of a relapse', 'description': 'In each group of treatment, prognostic value of longitudinal MOG-Ab-titers to predict relapse.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MOGAD', 'azathioprine', 'optic neuritis', 'myelitis', 'neuromyelitis optica', 'MOG-IgG associated disease'], 'conditions': ['Central Nervous System Inflammation', 'MOG-IgG Associated Disease']}, 'descriptionModule': {'briefSummary': '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.\n\nNo 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥ 18 years\n* First attack of documented acute demyelinating syndrome of the central nervous system, within the past 3 months, whatever the severity or the clinical phenotype\n* Tested positive for MOG-Ab, confirmed in a centralized lab (Lyon referral centre)\n* Ability of the subject to understand the purpose and risks of the study and provide signed and dated written informed consent.\n* Patients should be beneficiary of health care coverage under the social security system\n* Female patients of childbearing potential should have effective contraception throughout the course of treatment and for at least three months after stopping treatment.\n\nExclusion Criteria:\n\n* Hypersensitivity to azathioprine or steroids\n* Active infections or cancer (including tuberculosis, hepatitis, herpes and VZV)\n* Psychosis not controlled by treatment\n* Seriously impaired bone marrow functions: Lymphocyte count \\< 1000/ml and or Polynuclear neutrophil count \\< 1500/ml\n* Seriously impaired hepatic functions: ALT and/or AST \\> 3N\n* Seriously impaired renal functions: GFR \\< 29 ml/min/1.73m²\n* Any live vaccine in the past 3 months or planned during the RCT and RCT+6months\n* Thiopurine methyltransferase (TPMT) phenotype deficient or intermediate, with enzymatic activity \\< 16 nmol/h/ml\n* Unable to complete an MRI (e.g. due to pacemaker, severe claustrophobia, hypersensitivity to contrast media, or who lack adequate peripheral venous access)\n* Necessary use of a xanthine oxidase inhibitor (Allopurinol, Oxipurinol, Thiopurinol, Febuxotat,…)\n* Necessary use of angiotensin-converting-enzyme inhibitor, cotrimoxazole, cimetidine and indometacine\n* Necessary use of an aminosalicylate derivates\n* Necessary use of any another immunosuppressive therapy, different than azathioprine, or steroids\n* Necessary use of cytotoxic therapy\n* Necessary use of any other medical illness or disability that, in the opinion of the investigator, would compromise effective trial participation\n* 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.\n* 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\n* Patients with Lesch Nyhan syndrome\n* Asian patients (probable mutation of the gene NUDT1)\n* Female subjects who have a positive a positive urinary or blood pregnancy test result, are pregnant or are currently breast feeding\n* Inability to comply with study requirements\n* Person under legal protection or deprived of liberty"}, 'identificationModule': {'nctId': 'NCT05349006', 'acronym': 'MOGwAI', 'briefTitle': 'Azathioprine in MOGAD', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'A Randomized, Placebo-controlled Phase 3 Trial of Azathioprine for the Prevention of Relapse in Myelin-oligodendrocyte-glycoprotein (MOG)-Antibody Associated Disease', 'orgStudyIdInfo': {'id': '69HCL21_1065'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Azathioprine', 'description': 'Azathioprine, dose related to weight (100 mg for weight ≤ 50 kg and 150 mg for weight \\> 50 kg), oral, daily\n\nAssociated to oral corticosteroid, prednisone : 40 mg per day during three months, and progressively tapered during three months until stop (- 30 mg during 15 days, 20mg during 15 days, 15 mg during 15 days, 10 mg during 15 days, 5 mg during 15 days and introduction of hydrocortisone 20 mg + Stop prednisone; hydrocortisone 20mg during 15 days, Stop hydrocortisone)', 'interventionNames': ['Drug: Azathioprine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo, once a day, oral, number of caps related to weight\n\nAssociated to oral corticosteroid: prednisone 40 mg per day during three months and progressively tapered during three months until stop (- 30 mg during 15 days, 20mg during 15 days, 15 mg during 15 days, 10 mg during 15 days, 5 mg during 15 days and introduction of hydrocortisone 20 mg + Stop prednisone; hydrocortisone 20mg during 15 days, Stop hydrocortisone)', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Azathioprine', 'type': 'DRUG', 'description': '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', 'armGroupLabels': ['Azathioprine']}, {'name': 'Placebo', 'type': 'OTHER', 'description': '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', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bordeaux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Aurélie RUET, Pr', 'role': 'CONTACT', 'email': 'aurelie.ruet@chu-bordeaux.fr', 'phone': '+33 (0)5 56 79 55 21'}], 'facility': 'Department of Neurology, CHU de Bordeaux - GH Pellegrin', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Helene ZEPHIR, Pr', 'role': 'CONTACT', 'email': 'thi-helene.zephir@chru-lille.fr', 'phone': '+33 (0)3 20 44 68 46'}], 'facility': 'Department of Neurology, CHU of Lille, Hospital Roger Salengro', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Caroline FROMENT, Pr', 'role': 'CONTACT', 'email': 'caroline.froment01@chu-lyon.fr', 'phone': '+33 (0)472118012'}], 'facility': 'Department of Neuro Ophthalmology, CHU of Lyon, Neurology Hospital Pierre Wertheimer', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Romain MARIGNIER, Pr', 'role': 'CONTACT', 'email': 'romain.marignier@chu-lyon.fr', 'phone': '+33 4 72 35 75 22'}], 'facility': 'Service de Neurologie sclérose en plaques, pathologies de la myéline et neuro-inflammation - Centre de référence des maladies inflammatoires rares du cerveau et de la moelle (MIRCEM) - Hôpital Neurologique Pierre Wertheimer - Hospices Civils de Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Bertrand AUDOIN, Pr', 'role': 'CONTACT', 'email': 'bertrand.audoin@ap-hm.fr', 'phone': '+33 (0)4 91 38 59 39'}], 'facility': 'Department of Neurology University hospital Timone', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Xavier AYRIGNAC, Dr', 'role': 'CONTACT', 'email': 'x-ayrignac@chu-montpellier.fr', 'phone': '+33 (0)4 67 33 94 69'}], 'facility': 'Department of Neurology Montpellier Universitary Hospital', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '54035', 'city': 'Nancy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Guillaume MATHEY, md', 'role': 'CONTACT', 'email': 'g.mathey@chru-nancy.fr', 'phone': '03.83.85.16.88'}], 'facility': 'CHRU de Nancy Hôpital Central', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'city': 'Nice', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Mikael COHEN, Dr', 'role': 'CONTACT', 'email': 'cohen.m@chu-nice.fr', 'phone': '+33 (0)4 92 03 98 93'}], 'facility': 'Department of Neurology, Hôpital Pasteur 2', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'city': 'Nîmes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Eric THOUVENOT, Pr', 'role': 'CONTACT', 'email': 'eric.thouvenot@chu-nimes.fr', 'phone': '+33 (0)4 66 68 32 61'}], 'facility': 'Department of Neurology, Hôpital Caremeau', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '75012', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jennifer ABOAB, MD', 'role': 'CONTACT', 'email': 'jaboab@15-20.fr', 'phone': '06 20 35 14 56'}], 'facility': 'National Hospital of Vision (15-20)', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Elisabeth MAILLART, Dr', 'role': 'CONTACT', 'email': 'elisabeth.maillart@aphp.fr', 'phone': '+33 (0)1 42 16 19 75'}], 'facility': 'Department of Neurology APHP, Pitié Salpêtrière Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Romain DESCHAMPS, Dr', 'role': 'CONTACT', 'email': 'rdeschamps@for.paris', 'phone': '+33 (0)1 48 03 68 52'}], 'facility': 'Department of Neurology. Hôpital A. Fondation Rothschild', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Rennes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Laure MICHEL, Dr', 'role': 'CONTACT', 'email': 'laure.michel@chu-rennes.fr', 'phone': '+33 (0)2 99 28 98 42'}], 'facility': 'Department of Neurology, CHU de Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Rouen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Bertrand BOURRE, Dr', 'role': 'CONTACT', 'email': 'bertrand.bourre@chu-rouen.fr', 'phone': '+33 (0)2 32 88 67 49'}], 'facility': 'Department of Neurology, CHU de Rouen', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'city': 'Saint-Herblain', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'David LAPLAUD, Pr', 'role': 'CONTACT', 'email': 'david.laplaud@chu-nantes.fr', 'phone': '+33 (0)2 40 16 52 12'}], 'facility': 'Department of Neurology, Hôpital g. Et r. Laennec', 'geoPoint': {'lat': 47.21154, 'lon': -1.651}}, {'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nicolas COLLONGUES, Dr', 'role': 'CONTACT', 'email': 'nicolas.collongues@chru-strasbourg.fr', 'phone': '+33 (0)88 12 85 44'}], 'facility': 'Department of Neurology, Hôpital Hautepierre', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jonathan CIRON, Dr', 'role': 'CONTACT', 'email': 'ciron.j@chu-toulouse.fr', 'phone': '+33 (0)5 61 77 91 06'}], 'facility': 'Department of Neurology, Toulouse Universitary Hospital', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'centralContacts': [{'name': 'Romain MARIGNIER, MD PhD', 'role': 'CONTACT', 'email': 'romain.marignier@chu-lyon.fr', 'phone': '+334 72 35 75 22'}, {'name': 'Lakhdar BENYAHYA, project manager', 'role': 'CONTACT', 'email': 'lakhdar.benyahya@chu-lyon.fr', 'phone': '+334 72 68 49 07'}], 'overallOfficials': [{'name': 'Romain MARIGNIER, MD PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospices Civils de Lyon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}