Epidemiological Study of Treatment Approaches in AChR-Antibody Positive Generalized Myasthenia Gravis in Russia

NCT07247279 | Recruiting

• 1 other identifier: D9281R00003
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 5

Brief Summary

This is a multicenter, non-interventional, retrospective-prospective, single-arm observational study designed to describe real-world treatment approaches and clinical outcomes among adults with acetylcholine receptor (AChR) antibody-positive generalized myasthenia gravis (gMG) in routine clinical practice in Russia.

Conditions

Rare Diseases; Generalized Myasthenia Gravis (gMG)

Outcome Measures

Primary Outcomes (9)

• Age at baseline (years)

  Patient age in full years at study enrollment (ICF signing). Summarized as a quantitative variable and as categorical distribution by ≤50 years vs \>50 years.

  Baseline (Month 0; at informed consent and enrollment)

• Age at gMG diagnosis (years)

  Patient age in full years at the date of generalized myasthenia gravis (gMG) diagnosis. Summarized as a quantitative variable and as categorical distribution by ≤50 years vs \>50 years.

  Baseline (retrospective abstraction at Month 0)

• Sex and ethnicity distribution

  Proportion of patients by sex (male, female) and ethnicity (White, Asian, Black, other) recorded at enrollment.

  Baseline (Month 0)

• Body Mass Index (BMI)

  BMI in kg/m\^2 calculated as weight (kg)/height (m)\^2 using the most recent values closest to enrollment, summarized as mean, SD, median, IQR, minimum, maximum. Height and weight are abstracted from medical records.

  Baseline (Month 0; last available measurements closest to ICF signing)

• Disease duration (days)

  Time between the date of documented gMG diagnosis and the date of informed consent/enrollment, summarized as median and IQR (and mean, SD, min, max). Calculated in months/years based on dates abstracted from medical records to the eCRF.

  Baseline (Month 0)

• Clinical symptom profile of gMG

  Proportion of patients presenting each predefined gMG symptom category at enrollment (ocular, bulbar, respiratory, chewing/facial, limb/trunk/neck weakness, autonomic dysfunction subdomains); summarized as counts and percentages.

  Baseline (Month 0)

• Comorbidity profile

  Proportion of patients with specified comorbidities in history or present at enrollment: autoimmune thyroiditis/hyperthyroidism, systemic lupus erythematosus, rheumatoid arthritis, autoimmune encephalitis, arterial hypertension, hyperlipidemia.

  Baseline (Month 0)

• Number and proportion of patients with gMG-related hospitalizations

  Patients with ≥1 hospitalization attributed to gMG (investigator judgment) from date of gMG diagnosis to ICF signing.

  Retrospective period from gMG diagnosis to Baseline (Month 0)

• Duration of gMG-related hospitalizations (days)

  Sum of days of gMG-related hospitalizations per patient from gMG diagnosis to ICF signing.

  Retrospective period from gMG diagnosis to Baseline (Month 0)

Secondary Outcomes (27)

• MG-ADL total score and change from baseline

  Baseline (Month 0) and Months 6, 12, 18, 24, 30, 36 (±1 month)

• QMG total score and change from baseline

  Baseline (Month 0) and Months 6, 12, 18, 24, 30, 36 (±1 month)

• Distribution of MGFA clinical classification over time

  Baseline (Month 0) and Months 6, 12, 18, 24, 30, 36 (±1 month)

• Number and proportion of patients with all-cause hospitalization

  From Baseline through Months 6, 12, 18, 24, 30, 36 (±1 month)

• Duration of all-cause hospitalizations (days per participant)

  From Baseline through Months 6, 12, 18, 24, 30, 36 (±1 month)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants of both sexes aged 18 years and older with diagnosis of AChR-antibody positive generalized MG will be enrolled in various clinical institutions in Russia that provide treatment for gMG patients.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (5)

Research Site

Kazan', Russia

RECRUITING

Research Site

Moscow, Russia

RECRUITING

Research Site

Novosibirsk, Russia

RECRUITING

Research Site

Rostov-on-Don, Russia

RECRUITING

Research Site

Samara, Russia

RECRUITING

MeSH Terms

Conditions

Rare Diseases; Myasthenia Gravis

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 25, 2025
• Study Start: December 23, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

RU (5)