Treatment approaches for AChR-antibody positive generalized myasthenia gravis in Russia.

A Multicenter Non Interventional Single Arm Retrospective-prospective Observational Study in Therapeutic Approaches in AChR-Antibody Positive Generalized Myasthenia Gravis (gMG) in Real Clinical Practice in Russia

This project will look at which treatments adults in Russia with AChR-antibody positive generalized myasthenia gravis receive and how their symptoms and hospitalizations change over time.

Quick facts

• Study type: Observational
• Enrollment: 450 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: AstraZeneca (Industry-sponsored)
• Drugs / interventions: rituximab
• Locations: 6 sites (Kazan' and 5 other locations)
• Trial ID: NCT07247279 on ClinicalTrials.gov

What this trial studies

This multicenter, non-interventional, retrospective-prospective single-arm study will enroll about 100 adults with AChR-antibody positive generalized myasthenia gravis across roughly 10 specialized sites in Russia. Clinical data will be collected consecutively from existing medical records and entered into an electronic case report form at seven predefined timepoints, capturing scores such as MG-ADL, QMG, and MGFA class. The study will document diagnostic pathways, first-line and subsequent treatments (including anticholinesterase agents, corticosteroids, immunosuppressants, IVIG, plasmapheresis/plasma filtration, thymectomy, rituximab, and complement C5 inhibitors), rates and reasons for hospitalizations, myasthenic crises, and meningococcal vaccination or prophylactic antibiotic use prior to C5 inhibitor therapy. Enrollment requires written informed consent and excludes patients with ocular-only MG or those currently enrolled in interventional gMG trials.

Who should consider this trial

Good fit: Adults (age ≥18) in Russia with generalized myasthenia gravis who test positive for acetylcholine receptor antibodies and can provide written informed consent are the intended participants.

Not a fit: People with only ocular myasthenia gravis, patients already enrolled in interventional gMG trials, or those unable to access participating Russian sites are unlikely to be included or directly benefit from this study's findings.

Why it matters

Potential benefit: If successful, the results could help clinicians in Russia make more informed treatment choices by showing real-world patterns and outcomes for AChR-positive gMG.

How similar studies have performed: Other non-interventional registries and real-world cohorts in myasthenia gravis have provided useful information on treatment patterns and outcomes, so this approach is well-established rather than novel.

Eligibility criteria

Inclusion Criteria:

1. Adults (≥18 years) diagnosed with generalized MG positive for acetylcholine receptor (AChR) antibodies.
2. Provision of signed and dated written informed consent.

Exclusion Criteria:

1. Participants currently enrolled in clinical studies for treatment of gMG.
2. Ocular MG only.

Where this trial is running

Kazan' and 5 other locations

• Research Site — Kazan', Russia (Recruiting)
• Research Site — Moscow, Russia (Recruiting)
• Research Site — Novosibirsk, Russia (Recruiting)
• Research Site — Rostov-on-Don, Russia (Recruiting)
• Research Site — Saint Petersburg, Russia (Not_yet_recruiting)
• Research Site — Samara, Russia (Recruiting)

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center

Conditions Rare Diseases; Generalized Myasthenia Gravis