Epidemiological Study of Treatment Approaches in AChR-Antibody Positive Generalized Myasthenia Gravis in Russia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAstraZeneca
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults (≥18 years) diagnosed with generalized MG positive for acetylcholine receptor (AChR) antibodies.
Provision of signed and dated written informed consent.
Disqualifiers
Participants currently enrolled in clinical studies for treatment of gMG.
Ocular MG only.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (Month 0; at informed consent and enrollment)2
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.
Time frame
Baseline (retrospective abstraction at Month 0)3
Sex and ethnicity distribution
Proportion of patients by sex (male, female) and ethnicity (White, Asian, Black, other) recorded at enrollment.
Time frame
Baseline (Month 0)4
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.
Time frame
Baseline (Month 0; last available measurements closest to ICF signing)Secondary outcomes
1
MG-ADL total score and change from baseline
Patient-reported MG-ADL total score (range 0-24; higher=worse). Report descriptive statistics at each time point and change from Baseline (visit value minus Baseline). Scores are abstracted from routine care records; only total scores documented in source are collected.
Time frame
Baseline (Month 0) and Months 6, 12, 18, 24, 30, 36 (±1 month)2
QMG total score and change from baseline
Physician-reported QMG total score (0-39; higher=worse). Metrics: absolute score and change from baseline. Summarized descriptively. Collected only if present in routine practice records.
Time frame
Baseline (Month 0) and Months 6, 12, 18, 24, 30, 36 (±1 month)3
Distribution of MGFA clinical classification over time
Proportion of participants in each MGFA class (I, IIa/IIb, IIIa/IIIb, IVa/IVb, V) at each time point. Also report proportion improving (lower class) or worsening (higher class) versus Baseline. MGFA class is abstracted only if recorded in routine practice.
Time frame
Baseline (Month 0) and Months 6, 12, 18, 24, 30, 36 (±1 month)4
Number and proportion of patients with all-cause hospitalization
Patients experiencing ≥1 hospitalization for any cause during prospective follow-up. Metric: count and proportion (percentage) of patients with ≥1 event. Each participant's status (yes/no) assessed across the follow-up period.
Time frame
From Baseline through Months 6, 12, 18, 24, 30, 36 (±1 month)Sponsors and contacts
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Source ClinicalTrials.gov