Central Nervous System InflammationPhase 3MOGwAINCT05349006
Azathioprine in MOGAD
A Phase 3 study testing Azathioprine in people with Central Nervous System Inflammation and MOG-IgG Associated Disease, run by Hospices Civils de Lyon at 17 sites in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Nervous System Inflammation, MOG-IgG Associated Disease
- What is being tested?
- Azathioprine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 17 sitesFrance
- Study dates
- 12 Dec 2023to 12 Dec 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
17 sites in 1 country. Contact the study team or a site near you to ask about taking part.
17 sites in 1 country
France17 sites, 17 recruiting
- Recruiting
Department of Neurology, CHU de Bordeaux - GH Pellegrin
Bordeaux
Aurélie RUET, Pr, +33 (0)5 56 79 55 21, aurelie.ruet@chu-bordeaux.fr
- Recruiting
Department of Neurology, CHU of Lille, Hospital Roger Salengro
Lille
Helene ZEPHIR, Pr, +33 (0)3 20 44 68 46, thi-helene.zephir@chru-lille.fr
- Recruiting
Department of Neuro Ophthalmology, CHU of Lyon, Neurology Hospital Pierre Wertheimer
Lyon
Caroline FROMENT, Pr, +33 (0)472118012, caroline.froment01@chu-lyon.fr
- Recruiting
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
Lyon
Romain MARIGNIER, Pr, +33 4 72 35 75 22, romain.marignier@chu-lyon.fr
- Recruiting
Department of Neurology University hospital Timone
Marseille
Bertrand AUDOIN, Pr, +33 (0)4 91 38 59 39, bertrand.audoin@ap-hm.fr
- Recruiting
Department of Neurology Montpellier Universitary Hospital
Montpellier
Xavier AYRIGNAC, Dr, +33 (0)4 67 33 94 69, x-ayrignac@chu-montpellier.fr
- Recruiting
CHRU de Nancy Hôpital Central
Nancy, 54035
Guillaume MATHEY, md, 03.83.85.16.88, g.mathey@chru-nancy.fr
- Not yet recruiting
Department of Neurology, Hôpital Pasteur 2
Nice
Mikael COHEN, Dr, +33 (0)4 92 03 98 93, cohen.m@chu-nice.fr
- Recruiting
Department of Neurology, Hôpital Caremeau
Nîmes
Eric THOUVENOT, Pr, +33 (0)4 66 68 32 61, eric.thouvenot@chu-nimes.fr
- Recruiting
National Hospital of Vision (15-20)
Paris, 75012
Jennifer ABOAB, MD, 06 20 35 14 56, jaboab@15-20.fr
- Recruiting
Department of Neurology APHP, Pitié Salpêtrière Hospital
Paris
Elisabeth MAILLART, Dr, +33 (0)1 42 16 19 75, elisabeth.maillart@aphp.fr
- Recruiting
Department of Neurology. Hôpital A. Fondation Rothschild
Paris
Romain DESCHAMPS, Dr, +33 (0)1 48 03 68 52, rdeschamps@for.paris
- Recruiting
Department of Neurology, CHU de Rennes
Rennes
Laure MICHEL, Dr, +33 (0)2 99 28 98 42, laure.michel@chu-rennes.fr
- Recruiting
Department of Neurology, CHU de Rouen
Rouen
Bertrand BOURRE, Dr, +33 (0)2 32 88 67 49, bertrand.bourre@chu-rouen.fr
- Recruiting
Department of Neurology, Hôpital g. Et r. Laennec
Saint-Herblain
David LAPLAUD, Pr, +33 (0)2 40 16 52 12, david.laplaud@chu-nantes.fr
- Recruiting
Department of Neurology, Hôpital Hautepierre
Strasbourg
Nicolas COLLONGUES, Dr, +33 (0)88 12 85 44, nicolas.collongues@chru-strasbourg.fr
- Recruiting
Department of Neurology, Toulouse Universitary Hospital
Toulouse
Jonathan CIRON, Dr, +33 (0)5 61 77 91 06, ciron.j@chu-toulouse.fr
About this study
Official title: A Randomized, Placebo-controlled Phase 3 Trial of Azathioprine for the Prevention of Relapse in Myelin-oligodendrocyte-glycoprotein (MOG)-Antibody Associated Disease
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.
- Being tested
- Azathioprine, Placebo
- Keywords
- MOGAD, azathioprine, optic neuritis, myelitis, neuromyelitis optica, MOG-IgG associated disease
- Medical subject headings
- Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease, Optic Neuritis, Myelitis, Neuromyelitis Optica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzathioprineDrug
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
PlaceboOther
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
| Study group | Role | What they receive |
|---|---|---|
| Azathioprine | Experimental | Azathioprine, dose related to weight (100 mg for weight ≤ 50 kg and 150 mg for weight > 50 kg), oral, daily
Associated 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) Receives: Drug: Azathioprine |
| Placebo | Placebo comparator | Placebo, once a day, oral, number of caps related to weight
Associated 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) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first relapse (in days), comparing azathioprine-treated vs placebo-treated patients during a randomized control period of a maximum of three years.
A definite relapse will be defined as such:
- 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.
- If this second neurologist also considers the patient as experiencing a relapse, the patient will be considered as relapsing for the main analysis.
- If the second neurologist disagrees, the opinion of a third neurologist will be asked and the majority opinion will be retained.
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).
Measured: During a randomized control period of a maximum of three years
Secondary outcomes (18)
Number and type of adverse events, including serious adverse events, related to azathioprine and/or steroids and placebo
Measured: : During a randomized control period of a maximum of three years
Evaluation of global disability 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.
Measured: at baseline and at 36 months
Evaluation of global disability at 36 months
Worsening from baseline to 36 months of the EDSS
Measured: at baseline and at 36 months
Evaluation of global disability 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.
Measured: at baseline and at 36 months
Evaluation of global disability at 36 months
Worsening from baseline to 36 months of the Ambulation Score.
Measured: at baseline and at 36 months
Evaluation of visual disability at 36 months
Best-corrected high contrast visual acuity at 36 months measured (each eye tested separately) using the standard Snellen chart or equivalent.
Measured: at baseline and at 36 months
Evaluation of visual disability 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).
Measured: at baseline and at 36 months
Evaluation of visual disability at 36 months
Best-corrected low-contrast visual acuity at 36 months using the Sloan Charts at 2.5%, in each eye.
Measured: at baseline and at 36 months
Evaluation of visual disability at 36 months
Worsening from baseline to 36 months of low-contrast visual acuity using the Sloan Charts at 2.5%, in each eye.
Measured: at baseline and at 36 months
Evaluation of visual disability at 36 months
Inner retinal layers thicknesses at 36 months assessed by the spectral domain OCT (each eye tested separately)
Measured: at baseline and at 36 months
Evaluation of visual disability 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).
Measured: at baseline and at 36 months
Quality of life will be assessed using the EuroQOL EQ-5D-3L at 36 months
https://euroqol.org
Measured: at 36 months
Compliance to treatment
percentage of untaken pills (left in the blisters) regarding each patient
Measured: During a randomized control period of a maximum of three years
Exploratory radiological features
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
Measured: at baseline and at 36 months
Exploratory radiological features
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
Measured: at baseline and at 36 months
Exploratory biological features
In each group of treatment, association between MOG-Ab titer at first episode and the risk of relapse
Measured: at screening, at 6 months, at 12 months, at 36 months and in case of a relapse
Exploratory biological features
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.
Measured: at screening, at 6 months, at 12 months, at 36 months and in case of a relapse
Exploratory biological features
In each group of treatment, prognostic value of longitudinal MOG-Ab-titers to predict relapse.
Measured: at screening, at 6 months, at 12 months, at 36 months and in case of a relapse
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start12 Dec 2023
- Primary completion12 Dec 2026 (estimated)
- Study completion12 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Nervous System InflammationStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Romain MARIGNIER, MD PhD, Study director, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05349006
- Sponsor's protocol ID
- 69HCL21_1065
- Acronym
- MOGwAI
- Status last verified
- Jan 2025
- First submitted
- 15 Apr 2022
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled Phase 3 Trial of Azathioprine for the Prevention of Relapse in Myelin-oligodendrocyte-glycoprotein (MOG)-Antibody Associated Disease
- ClinicalTrials.gov ID
- NCT05349006
- Acronym / sponsor ID
- MOGwAI / 69HCL21_1065
- Keywords
- MOGAD, azathioprine, optic neuritis, myelitis, neuromyelitis optica, MOG-IgG associated disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 12 Dec 2023 (actual)
- Primary completion
- 12 Dec 2026 (estimated)
- Study completion
- 12 Dec 2029 (estimated)
- First posted
- 27 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Azathioprine | Experimental | Drug: AzathioprineAzathioprine, dose related to weight (100 mg for weight ≤ 50 kg and 150 mg for weight > 50 kg), oral, daily Associated 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) |
| Placebo | Placebo comparator | Other: PlaceboPlacebo, once a day, oral, number of caps related to weight Associated 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AzathioprineDose 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 | Drug | Azathioprine |
| PlaceboDose 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 | Other | Placebo |
Primary outcome
Time to first relapse (in days), comparing azathioprine-treated vs placebo-treated patients during a randomized control period of a maximum of three years.
Time frame: During a randomized control period of a maximum of three years
A definite relapse will be defined as such: * 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. * If this second neurologist also considers the patient as experiencing a relapse, the patient will be considered as relapsing for the main analysis. * If the second neurologist disagrees, the opinion of a third neurologist will be asked and the majority opinion will be retained. 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).
18 secondary outcomes
Number and type of adverse events, including serious adverse events, related to azathioprine and/or steroids and placebo
Time frame: : During a randomized control period of a maximum of three years
Evaluation of global disability at 36 months
Time frame: at baseline and at 36 months
Evaluation of global disability at 36 months
Time frame: at baseline and at 36 months
Evaluation of global disability at 36 months
Time frame: at baseline and at 36 months
Evaluation of global disability at 36 months
Time frame: at baseline and at 36 months
Evaluation of visual disability at 36 months
Time frame: at baseline and at 36 months
Evaluation of visual disability at 36 months
Time frame: at baseline and at 36 months
Evaluation of visual disability at 36 months
Time frame: at baseline and at 36 months
Evaluation of visual disability at 36 months
Time frame: at baseline and at 36 months
Evaluation of visual disability at 36 months
Time frame: at baseline and at 36 months
Evaluation of visual disability at 36 months
Time frame: at baseline and at 36 months
Quality of life will be assessed using the EuroQOL EQ-5D-3L at 36 months
Time frame: at 36 months
Compliance to treatment
Time frame: During a randomized control period of a maximum of three years
Exploratory radiological features
Time frame: at baseline and at 36 months
Exploratory radiological features
Time frame: at baseline and at 36 months
Exploratory biological features
Time frame: at screening, at 6 months, at 12 months, at 36 months and in case of a relapse
Exploratory biological features
Time frame: at screening, at 6 months, at 12 months, at 36 months and in case of a relapse
Exploratory biological features
Time frame: at screening, at 6 months, at 12 months, at 36 months and in case of a relapse
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Romain MARIGNIER, MD PhD study director
Hospices Civils de Lyon
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Azathioprine in people with Central Nervous System Inflammation and MOG-IgG Associated Disease, run by Hospices Civils de Lyon at 17 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Romain MARIGNIER, MD PhD (+334 72 35 75 22, romain.marignier@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: During a randomized control period of a maximum of three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025.