Optic NeuritisMOGNCT03345537
Initial Clinical Presentation of Inflammatory Optic Neuritis Associated or Not With Autoantibodies Anti-Myelin-oligodendrocyte-glycoprotein
An observational study of Optic Neuritis, run by Nantes University Hospital at 8 sites in France.
Trial summary
In eight ophthalmic units, the investigator will include all inflammatory optic neuritis (ON) during acute phase and rank them in two groups: 1/ ON with autoantibodies anti-myelin-oligodendrocyte-glycoprotein (ON MOG+) 2/ ON MOG-. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Optic Neuritis
- What is being tested?
- Non interventional study
- How many people
- 103 participants
- Where
- 8 sitesFrance
- Study dates
- 12 Feb 2018to 31 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Phe patients included will be mostly young adults between 18 and 40 years old, consultant in the ophthalmology department of the University Hospital of Nantes for an inflammatory optic neuropathy
Who may be able to join
- legally adult patient
- acute inflammatory optic neuritis
- consent
Who cannot join
- Patient under tutorship
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
Chu Angers
Angers
Ch Challans
Challans
Ch Cholet
Cholet
Chd La Roche Sur Yon
La Roche-sur-Yon
Ch Laval
Laval
Chr Le Mans
Le Mans
CHU Nantes
Nantes
Ch Saint Nazaire
Saint-Nazaire
About this study
Official title: Observational Prospective Multicentered Study Evaluating Initial Clinical Presentation of Inflammatory Optic Neuritis (ON) Associated or Not With Autoantibodies Anti- Myelin-oligodendrocyte-glycoprotein (MOG-Ab)
In eight ophthalmic units, the investigator will include all inflammatory optic neuritis (ON) during acute phase and rank them in two groups: 1/ ON with autoantibodies anti-myelin-oligodendrocyte-glycoprotein (ON MOG+) 2/ ON MOG-. The investigators will measure incidence of MOG-Ab in our prospective population of inflammatory ON. Then the investigator will compare clinical and radiological presentation of ON MOG+ versus ON MOG-.
Read the detailed description
Optic neuritis (ON) have a broad clinical spectrum ranging from a single episode (clinically isolated ON) to demyelinating diseases such as multiple sclerosis (MS), Chronic Relapsing Inflammatory Optic Neuritis (CRION), acute demyelination encephalomyelitis (ADEM), neuromyelitis optica (NMO) and neuromyelitis optica spectrum disorder (NMOSD). Myelin oligodendrocyte glycoprotein (MOG) is a myelin antigen exclusively expressed on the surface of oligodendrocytes and myelin in the central nervous system (CNS). MOG-Ab are associated with demyelinating diseases with a good specificity. Using cell-based assays, MOG-Ab were rarely found in healthy control and other neurological inflammatory disease. They were mostly identified in subgroups of NMO/NMOSD seronegative to auto antibodies against Aquaporin 4 (anti-AQP4): 8-39%, but also in MS (0-28%) ADEM and idiopathic ON. ON MOG + have a specific clinical presentation compare with ON associated with multiple sclerosis (SEP): older patient, less female preponderance, more often bilateral, more often optic disc swelling, worse initial visual loss, much more often recurrent with severe sequelae. ON MOG+ are more similar to ON associated with NMOSD AQP4+ which have some particularities: similar age, clear female preponderance, less optic disc swelling, more severe initial visual loss and visual sequelae. No prospective study has measured incidence of
MOG-Ab in population of Inflammatory ON. And no prospective study has ever compared ON MOG+ with all others inflammatory ON. The purpose of our study is to measure incidence of MOG-Ab in population of acute inflammatory ON. All consenting adults with suspicion of ON followed in the 8 ophthalmic units who participate will be screened. They will have, as usual, clinical follow-up, blood test with MOG-Ab research, encephalic and optic nerves MRI, and steroid treatment if necessary. At the end of the acute phase, all patients diagnosed with inflammatory ON will be included and rank in 2 groups: 1/ ON with MOG-Ab (ON MOG+) 2/ ON without MOG-Ab (ON MOG-). Clinical data will be register at this inclusion visit. There will be no additional visit and no intervention. After measuring incidence of MOG-Ab, the investigator will compare clinical and radiological data of ON MOG+ and ON MOG-.
- Conditions
- Optic Neuritis
- Being tested
- Non interventional study
- Keywords
- Inflammatory, Optic neuritis, autoantibodies anti MOG
- Medical subject headings
- Optic Neuritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non interventional studyOther
Non interventional study - only data collected and one blood sample additional
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of anti-Myelin-oligodendrocyte-glycoprotein (MOG-ab)
Measured: the day of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start12 Feb 2018
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Optic NeuritisStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre Lebranchu, Dr, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03345537
- Sponsor's protocol ID
- RC17_0250
- Acronym
- MOG
- Status last verified
- Aug 2022
- First submitted
- 14 Nov 2017
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ramanathan S, Dale RC, Brilot F. Anti-MOG antibody: The history, clinical phenotype, and pathogenicity of a serum biomarker for demyelination. Autoimmun Rev. 2016 Apr;15(4):307-24. doi: 10.1016/j.autrev.2015.12.004. Epub 2015 Dec 17.
PubMed 26708342Akaishi T, Nakashima I, Takeshita T, Kaneko K, Mugikura S, Sato DK, Takahashi T, Nakazawa T, Aoki M, Fujihara K. Different etiologies and prognoses of optic neuritis in demyelinating diseases. J Neuroimmunol. 2016 Oct 15;299:152-157. doi: 10.1016/j.jneuroim.2016.09.007. Epub 2016 Sep 14.
PubMed 27725114Ramanathan S, Reddel SW, Henderson A, Parratt JD, Barnett M, Gatt PN, Merheb V, Kumaran RY, Pathmanandavel K, Sinmaz N, Ghadiri M, Yiannikas C, Vucic S, Stewart G, Bleasel AF, Booth D, Fung VS, Dale RC, Brilot F. Antibodies to myelin oligodendrocyte glycoprotein in bilateral and recurrent optic neuritis. Neurol Neuroimmunol Neuroinflamm. 2014 Oct 29;1(4):e40. doi: 10.1212/NXI.0000000000000040. eCollection 2014 Dec.
PubMed 25364774Havla J, Kumpfel T, Schinner R, Spadaro M, Schuh E, Meinl E, Hohlfeld R, Outteryck O. Myelin-oligodendrocyte-glycoprotein (MOG) autoantibodies as potential markers of severe optic neuritis and subclinical retinal axonal degeneration. J Neurol. 2017 Jan;264(1):139-151. doi: 10.1007/s00415-016-8333-7. Epub 2016 Nov 14.
PubMed 27844165Sato DK, Callegaro D, Lana-Peixoto MA, Waters PJ, de Haidar Jorge FM, Takahashi T, Nakashima I, Apostolos-Pereira SL, Talim N, Simm RF, Lino AM, Misu T, Leite MI, Aoki M, Fujihara K. Distinction between MOG antibody-positive and AQP4 antibody-positive NMO spectrum disorders. Neurology. 2014 Feb 11;82(6):474-81. doi: 10.1212/WNL.0000000000000101. Epub 2014 Jan 10.
PubMed 24415568Jarius S, Ruprecht K, Kleiter I, Borisow N, Asgari N, Pitarokoili K, Pache F, Stich O, Beume LA, Hummert MW, Ringelstein M, Trebst C, Winkelmann A, Schwarz A, Buttmann M, Zimmermann H, Kuchling J, Franciotta D, Capobianco M, Siebert E, Lukas C, Korporal-Kuhnke M, Haas J, Fechner K, Brandt AU, Schanda K, Aktas O, Paul F, Reindl M, Wildemann B; in cooperation with the Neuromyelitis Optica Study Group (NEMOS). MOG-IgG in NMO and related disorders: a multicenter study of 50 patients. Part 2: Epidemiology, clinical presentation, radiological and laboratory features, treatment responses, and long-term outcome. J Neuroinflammation. 2016 Sep 27;13(1):280. doi: 10.1186/s12974-016-0718-0.
PubMed 27793206Hoftberger R, Sepulveda M, Armangue T, Blanco Y, Rostasy K, Calvo AC, Olascoaga J, Ramio-Torrenta L, Reindl M, Benito-Leon J, Casanova B, Arrambide G, Sabater L, Graus F, Dalmau J, Saiz A. Antibodies to MOG and AQP4 in adults with neuromyelitis optica and suspected limited forms of the disease. Mult Scler. 2015 Jun;21(7):866-874. doi: 10.1177/1352458514555785. Epub 2014 Oct 24.
PubMed 25344373The clinical profile of optic neuritis. Experience of the Optic Neuritis Treatment Trial. Optic Neuritis Study Group. Arch Ophthalmol. 1991 Dec;109(12):1673-8. doi: 10.1001/archopht.1991.01080120057025.
PubMed 1841573Stiebel-Kalish H, Lotan I, Brody J, Chodick G, Bialer O, Marignier R, Bach M, Hellmann MA. Retinal Nerve Fiber Layer May Be Better Preserved in MOG-IgG versus AQP4-IgG Optic Neuritis: A Cohort Study. PLoS One. 2017 Jan 26;12(1):e0170847. doi: 10.1371/journal.pone.0170847. eCollection 2017.
PubMed 28125740Beck RW, Cleary PA, Anderson MM Jr, Keltner JL, Shults WT, Kaufman DI, Buckley EG, Corbett JJ, Kupersmith MJ, Miller NR, et al. A randomized, controlled trial of corticosteroids in the treatment of acute optic neuritis. The Optic Neuritis Study Group. N Engl J Med. 1992 Feb 27;326(9):581-8. doi: 10.1056/NEJM199202273260901.
PubMed 1734247Elsone L, Panicker J, Mutch K, Boggild M, Appleton R, Jacob A. Role of intravenous immunoglobulin in the treatment of acute relapses of neuromyelitis optica: experience in 10 patients. Mult Scler. 2014 Apr;20(4):501-4. doi: 10.1177/1352458513495938. Epub 2013 Aug 28.
PubMed 23986097Optic Neuritis Study Group. Visual function 15 years after optic neuritis: a final follow-up report from the Optic Neuritis Treatment Trial. Ophthalmology. 2008 Jun;115(6):1079-1082.e5. doi: 10.1016/j.ophtha.2007.08.004. Epub 2007 Nov 5.
PubMed 17976727Garcia-Martin E, Ara JR, Martin J, Almarcegui C, Dolz I, Vilades E, Gil-Arribas L, Fernandez FJ, Polo V, Larrosa JM, Pablo LE, Satue M. Retinal and Optic Nerve Degeneration in Patients with Multiple Sclerosis Followed up for 5 Years. Ophthalmology. 2017 May;124(5):688-696. doi: 10.1016/j.ophtha.2017.01.005. Epub 2017 Feb 7.
PubMed 28187977Beck RW, Gal RL, Bhatti MT, Brodsky MC, Buckley EG, Chrousos GA, Corbett J, Eggenberger E, Goodwin JA, Katz B, Kaufman DI, Keltner JL, Kupersmith MJ, Miller NR, Moke PS, Nazarian S, Orengo-Nania S, Savino PJ, Shults WT, Smith CH, Trobe JD, Wall M, Xing D; Optic Neuritis Study Group. Visual function more than 10 years after optic neuritis: experience of the optic neuritis treatment trial. Am J Ophthalmol. 2004 Jan;137(1):77-83. doi: 10.1016/s0002-9394(03)00862-6.
PubMed 14700647Pache F, Zimmermann H, Mikolajczak J, Schumacher S, Lacheta A, Oertel FC, Bellmann-Strobl J, Jarius S, Wildemann B, Reindl M, Waldman A, Soelberg K, Asgari N, Ringelstein M, Aktas O, Gross N, Buttmann M, Ach T, Ruprecht K, Paul F, Brandt AU; in cooperation with the Neuromyelitis Optica Study Group (NEMOS). MOG-IgG in NMO and related disorders: a multicenter study of 50 patients. Part 4: Afferent visual system damage after optic neuritis in MOG-IgG-seropositive versus AQP4-IgG-seropositive patients. J Neuroinflammation. 2016 Nov 1;13(1):282. doi: 10.1186/s12974-016-0720-6.
PubMed 27802824
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Prospective Multicentered Study Evaluating Initial Clinical Presentation of Inflammatory Optic Neuritis (ON) Associated or Not With Autoantibodies Anti- Myelin-oligodendrocyte-glycoprotein (MOG-Ab)
- ClinicalTrials.gov ID
- NCT03345537
- Acronym / sponsor ID
- MOG / RC17_0250
- Conditions
- Optic Neuritis
- Keywords
- Inflammatory, Optic neuritis, autoantibodies anti MOG
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 12 Feb 2018 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 17 Nov 2017 (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.
In eight ophthalmic units, the investigator will include all inflammatory optic neuritis (ON) during acute phase and rank them in two groups: 1/ ON with autoantibodies anti-myelin-oligodendrocyte-glycoprotein (ON MOG+) 2/ ON MOG-. The investigators will measure incidence of MOG-Ab in our prospective population of inflammatory ON. Then the investigator will compare clinical and radiological presentation of ON MOG+ versus ON MOG-.
Detailed description
Optic neuritis (ON) have a broad clinical spectrum ranging from a single episode (clinically isolated ON) to demyelinating diseases such as multiple sclerosis (MS), Chronic Relapsing Inflammatory Optic Neuritis (CRION), acute demyelination encephalomyelitis (ADEM), neuromyelitis optica (NMO) and neuromyelitis optica spectrum disorder (NMOSD). Myelin oligodendrocyte glycoprotein (MOG) is a myelin antigen exclusively expressed on the surface of oligodendrocytes and myelin in the central nervous system (CNS). MOG-Ab are associated with demyelinating diseases with a good specificity. Using cell-based assays, MOG-Ab were rarely found in healthy control and other neurological inflammatory disease. They were mostly identified in subgroups of NMO/NMOSD seronegative to auto antibodies against Aquaporin 4 (anti-AQP4): 8-39%, but also in MS (0-28%) ADEM and idiopathic ON. ON MOG + have a specific clinical presentation compare with ON associated with multiple sclerosis (SEP): older patient, less female preponderance, more often bilateral, more often optic disc swelling, worse initial visual loss, much more often recurrent with severe sequelae. ON MOG+ are more similar to ON associated with NMOSD AQP4+ which have some particularities: similar age, clear female preponderance, less optic disc swelling, more severe initial visual loss and visual sequelae. No prospective study has measured incidence of
MOG-Ab in population of Inflammatory ON. And no prospective study has ever compared ON MOG+ with all others inflammatory ON. The purpose of our study is to measure incidence of MOG-Ab in population of acute inflammatory ON. All consenting adults with suspicion of ON followed in the 8 ophthalmic units who participate will be screened. They will have, as usual, clinical follow-up, blood test with MOG-Ab research, encephalic and optic nerves MRI, and steroid treatment if necessary. At the end of the acute phase, all patients diagnosed with inflammatory ON will be included and rank in 2 groups: 1/ ON with MOG-Ab (ON MOG+) 2/ ON without MOG-Ab (ON MOG-). Clinical data will be register at this inclusion visit. There will be no additional visit and no intervention. After measuring incidence of MOG-Ab, the investigator will compare clinical and radiological data of ON MOG+ and ON MOG-.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Phe patients included will be mostly young adults between 18 and 40 years old, consultant in the ophthalmology department of the University Hospital of Nantes for an inflammatory optic neuropathy
Key inclusion criteria (3 listed)
- legally adult patient
- acute inflammatory optic neuritis
- consent
Key exclusion criteria (1 listed)
- Patient under tutorship
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 |
|---|---|---|
| Non interventional studyNon interventional study - only data collected and one blood sample additional | Other | – |
Primary outcome
Incidence of anti-Myelin-oligodendrocyte-glycoprotein (MOG-ab)
Time frame: the day of inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
- Background: PubMed 26708342Ramanathan S, Dale RC, Brilot F. Anti-MOG antibody: The history, clinical phenotype, and pathogenicity of a serum biomarker for demyelination. Autoimmun Rev. 2016 Apr;15(4):307-24. doi: 10.1016/j.autrev.2015.12.004. Epub 2015 Dec 17.
- Background: PubMed 27725114Akaishi T, Nakashima I, Takeshita T, Kaneko K, Mugikura S, Sato DK, Takahashi T, Nakazawa T, Aoki M, Fujihara K. Different etiologies and prognoses of optic neuritis in demyelinating diseases. J Neuroimmunol. 2016 Oct 15;299:152-157. doi: 10.1016/j.jneuroim.2016.09.007. Epub 2016 Sep 14.
- Background: PubMed 25364774Ramanathan S, Reddel SW, Henderson A, Parratt JD, Barnett M, Gatt PN, Merheb V, Kumaran RY, Pathmanandavel K, Sinmaz N, Ghadiri M, Yiannikas C, Vucic S, Stewart G, Bleasel AF, Booth D, Fung VS, Dale RC, Brilot F. Antibodies to myelin oligodendrocyte glycoprotein in bilateral and recurrent optic neuritis. Neurol Neuroimmunol Neuroinflamm. 2014 Oct 29;1(4):e40. doi: 10.1212/NXI.0000000000000040. eCollection 2014 Dec.
- Background: PubMed 27844165Havla J, Kumpfel T, Schinner R, Spadaro M, Schuh E, Meinl E, Hohlfeld R, Outteryck O. Myelin-oligodendrocyte-glycoprotein (MOG) autoantibodies as potential markers of severe optic neuritis and subclinical retinal axonal degeneration. J Neurol. 2017 Jan;264(1):139-151. doi: 10.1007/s00415-016-8333-7. Epub 2016 Nov 14.
- Background: PubMed 24415568Sato DK, Callegaro D, Lana-Peixoto MA, Waters PJ, de Haidar Jorge FM, Takahashi T, Nakashima I, Apostolos-Pereira SL, Talim N, Simm RF, Lino AM, Misu T, Leite MI, Aoki M, Fujihara K. Distinction between MOG antibody-positive and AQP4 antibody-positive NMO spectrum disorders. Neurology. 2014 Feb 11;82(6):474-81. doi: 10.1212/WNL.0000000000000101. Epub 2014 Jan 10.
- Background: PubMed 27793206Jarius S, Ruprecht K, Kleiter I, Borisow N, Asgari N, Pitarokoili K, Pache F, Stich O, Beume LA, Hummert MW, Ringelstein M, Trebst C, Winkelmann A, Schwarz A, Buttmann M, Zimmermann H, Kuchling J, Franciotta D, Capobianco M, Siebert E, Lukas C, Korporal-Kuhnke M, Haas J, Fechner K, Brandt AU, Schanda K, Aktas O, Paul F, Reindl M, Wildemann B; in cooperation with the Neuromyelitis Optica Study Group (NEMOS). MOG-IgG in NMO and related disorders: a multicenter study of 50 patients. Part 2: Epidemiology, clinical presentation, radiological and laboratory features, treatment responses, and long-term outcome. J Neuroinflammation. 2016 Sep 27;13(1):280. doi: 10.1186/s12974-016-0718-0.
- Background: PubMed 25344373Hoftberger R, Sepulveda M, Armangue T, Blanco Y, Rostasy K, Calvo AC, Olascoaga J, Ramio-Torrenta L, Reindl M, Benito-Leon J, Casanova B, Arrambide G, Sabater L, Graus F, Dalmau J, Saiz A. Antibodies to MOG and AQP4 in adults with neuromyelitis optica and suspected limited forms of the disease. Mult Scler. 2015 Jun;21(7):866-874. doi: 10.1177/1352458514555785. Epub 2014 Oct 24.
- Background: PubMed 1841573The clinical profile of optic neuritis. Experience of the Optic Neuritis Treatment Trial. Optic Neuritis Study Group. Arch Ophthalmol. 1991 Dec;109(12):1673-8. doi: 10.1001/archopht.1991.01080120057025.
- Background: PubMed 28125740Stiebel-Kalish H, Lotan I, Brody J, Chodick G, Bialer O, Marignier R, Bach M, Hellmann MA. Retinal Nerve Fiber Layer May Be Better Preserved in MOG-IgG versus AQP4-IgG Optic Neuritis: A Cohort Study. PLoS One. 2017 Jan 26;12(1):e0170847. doi: 10.1371/journal.pone.0170847. eCollection 2017.
- Background: PubMed 1734247Beck RW, Cleary PA, Anderson MM Jr, Keltner JL, Shults WT, Kaufman DI, Buckley EG, Corbett JJ, Kupersmith MJ, Miller NR, et al. A randomized, controlled trial of corticosteroids in the treatment of acute optic neuritis. The Optic Neuritis Study Group. N Engl J Med. 1992 Feb 27;326(9):581-8. doi: 10.1056/NEJM199202273260901.
- Background: PubMed 23986097Elsone L, Panicker J, Mutch K, Boggild M, Appleton R, Jacob A. Role of intravenous immunoglobulin in the treatment of acute relapses of neuromyelitis optica: experience in 10 patients. Mult Scler. 2014 Apr;20(4):501-4. doi: 10.1177/1352458513495938. Epub 2013 Aug 28.
- Background: PubMed 17976727Optic Neuritis Study Group. Visual function 15 years after optic neuritis: a final follow-up report from the Optic Neuritis Treatment Trial. Ophthalmology. 2008 Jun;115(6):1079-1082.e5. doi: 10.1016/j.ophtha.2007.08.004. Epub 2007 Nov 5.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Pierre Lebranchu, Dr principal investigator
Nantes University Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Optic Neuritis, run by Nantes University Hospital at 8 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 25 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of anti-Myelin-oligodendrocyte-glycoprotein (MOG-ab) (time frame: the day of inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03345537, which also lists 15 linked publications.
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 25 Aug 2022; AzTrials last refreshed its copy on 3 Nov 2026.