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A RANDOMIZED DOUBLE BLIND, PLACEBO-CONTROLLED NATIONAL MULTICENTER PHASE 3 TRIAL TO EVALUATE THE EFFICACY OF AZATHIOPRINE FOR THE PREVENTION OF RELAPSE IN PATIENTS WITH MYELIN OLIGODENDROCYTE GLYCOPROTEIN ANTIBODY ASSOCIATED DISEASE (MOG-AD) AFTER A FIRST ATTACK : MOGWAI
EU CTIS ID: 2022-500520-30-00
What this study is testing
The primary endpoint is the time to first relapse, comparing azathioprine-treated vs placebo-treated patients during a randomized control period of a maximum of three years.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Age ≥ 18 years
- 2. First attack of documented acute demyelinating syndrome of the central nervous system, within the past 3 months, whatever the severity or the clinical phenotype
- 3. Tested positive for MOG-Ab, confirmed in a centralized lab (Lyon referral center)
- Capacity of the subject to understand the purpose and risks of the study and provide signed and dated written informed consent.
- 5. Patients should be beneficiary of health care coverage under the social security system
- 6. Female patients of childbearing potential should have effective contraception throughout the course of treatment and for at least three months after stopping treatment.
You likely can't join if
- 1. Hypersensitivity to azathioprine or steroids
- 10. Necessary use of angiotensin-converting-enzyme inhibitor, cotrimoxazole, cimetidine and indometacine
- 11. Necessary use of an aminosalicylate derivates
- 12. Necessary use of any another immunosuppressive therapy, different than azathioprine, or steroids
- 13. Necessary use of cytotoxic therapy
- 14. Current enrollment or a plan to enroll in any interventional clinical study in which an investigational treatment or approved therapy is use. 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.
See the full eligibility criteria
- 1. Age ≥ 18 years
- 2. First attack of documented acute demyelinating syndrome of the central nervous system, within the past 3 months, whatever the severity or the clinical phenotype
- 3. Tested positive for MOG-Ab, confirmed in a centralized lab (Lyon referral center)
- Capacity of the subject to understand the purpose and risks of the study and provide signed and dated written informed consent.
- 5. Patients should be beneficiary of health care coverage under the social security system
- 6. Female patients of childbearing potential should have effective contraception throughout the course of treatment and for at least three months after stopping treatment.
- 1. Hypersensitivity to azathioprine or steroids
- 10. Necessary use of angiotensin-converting-enzyme inhibitor, cotrimoxazole, cimetidine and indometacine
- 11. Necessary use of an aminosalicylate derivates
- 12. Necessary use of any another immunosuppressive therapy, different than azathioprine, or steroids
- 13. Necessary use of cytotoxic therapy
- 14. Current enrollment or a plan to enroll in any interventional clinical study in which an investigational treatment or approved therapy is use. 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.
- 15. Female subjects who have a positive blood pregnancy test result, are pregnant or are currently breast feeding
- 16. Inability to comply with study requirements
- 17. Person under legal protection or deprived of liberty
- 2. Active infections or cancer
- 3. Seriously impaired bone marrow functions: Lymphocyte count < 1000/ml and or Polynuclear neutrophil count < 1500/ml
- 4. Seriously impaired hepatic functions: ALT and/or AST > 3N
- 5. Seriously impaired renal functions: GFR < 29 ml/min/1.73m²
- 6. Any live vaccine in the past 3 months
- 7. Thiopurine methyltransferase (TPMT) phenotype deficient or intermediate, with enzymatic activity < 16 nmol/h/ml
- 8. Unable to complete an MRI (e.g. due to pacemaker, severe claustrophobia, hypersensitivity to contrast media, or who lack adequate peripheral venous access)
- 9. Necessary use of a xanthine oxidase inhibitor (Allopurinol, Oxipurinol, Thiopurinol, Febuxotat,…)
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.