Ongoing Clinical Trials for Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease
Currently, there is 1 ongoing clinical trial investigating treatment approaches for myelin oligodendrocyte glycoprotein antibody-associated disease (also known as: MOGAD, MOG antibody-associated disease, Anti-MOG associated disorders). This study is being conducted in France and focuses on comparing early versus delayed treatment strategies in children using immunosuppressive medications.
Clinical trial locations
Study of Early versus Delayed Treatment with Azathioprine or Rituximab in Children with Anti-MOG Antibody Disease
This clinical trial is investigating the best timing for starting treatment in children with myelin oligodendrocyte glycoprotein antibody-associated disease. The condition occurs when the immune system mistakenly attacks the protective covering of nerve cells in the brain, spinal cord, and optic nerves, leading to inflammation and various neurological symptoms.
Main focus of the trial: The study compares two different treatment approaches over a 24-month period. One group of children will start treatment immediately after their first attack of the disease, while another group will wait and begin treatment only after experiencing a second attack. The researchers want to determine which approach is better at preventing disease relapses and protecting children’s long-term health.
Investigational drugs being tested: The trial is studying two medications. Azathioprine is an oral medication taken as tablets that suppresses the immune system by interfering with DNA synthesis in immune cells. Rituximab is given through an intravenous infusion and works by targeting and reducing specific immune cells called B cells that carry the CD20 marker. Both medications aim to control the immune system’s attack on the nervous system. During the study, participants may also receive methylprednisolone, prednisone, and prednisolone to help manage acute symptoms.
Inclusion criteria: Children eligible for this trial must be between 6 and 17 years old and weigh at least 20 kilograms. They must be experiencing acute neurological symptoms lasting more than 24 hours caused by inflammation, which may include optic neuritis (inflammation of the eye nerve), transverse myelitis (spinal cord inflammation), or rhombencephalitis (inflammation of the lower brain). Confirmed presence of anti-MOG antibodies in the blood is required. Participants should not have received previous treatments except steroids and must have a disability score (EDSS) less than 5.5, indicating the condition has not severely impacted daily activities. Both parents and the child must provide informed consent, and the family must have French social security coverage.
Exclusion criteria: Children younger than 2 years or older than 18 years cannot participate. Those who have previously received azathioprine or rituximab are excluded. The trial also excludes children with a history of serious allergic reactions to medications, active or chronic infections (including tuberculosis, hepatitis B, or hepatitis C), severe liver or kidney problems, pregnancy or breastfeeding status, cancer in the past 5 years, severe heart conditions, or known immunodeficiency disorders. Children without confirmed MOG antibodies in their blood or those with mental conditions that prevent understanding of study requirements cannot join the trial. Participation in other clinical trials within the past 30 days also disqualifies potential participants.
What to expect during the trial: Participants will be randomly assigned to one of three groups: immediate treatment with azathioprine, immediate treatment with rituximab, or delayed treatment. Those in the immediate treatment groups will begin medication right after their first episode, starting with methylprednisolone given through an intravenous line, followed by oral prednisone or prednisolone. Children assigned to azathioprine will take tablets orally, while those receiving rituximab will have the medication administered through an intravenous line. Throughout the 24-month study period, participants will undergo regular health assessments, brain imaging scans, and monitoring for any new symptoms or side effects. The medical team will track disease relapses and evaluate how well each treatment approach works in preventing future attacks.
Summary
The single ongoing clinical trial for myelin oligodendrocyte glycoprotein antibody-associated disease is being conducted exclusively in France and focuses on the pediatric population. This trial represents an important effort to understand the optimal timing for initiating immunosuppressive treatment in children with this rare autoimmune condition. The study’s comparison of immediate versus delayed treatment strategies, using well-established immunosuppressive medications like azathioprine and rituximab, aims to provide evidence-based guidance for clinicians managing children with anti-MOG antibody disease. The 24-month follow-up period will help determine whether early intervention can better prevent disease relapses and improve long-term outcomes for young patients.
