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
Study tracks real-world treatments for generalized myasthenia gravis in Russia
Plain English Summary
Epidemiological Study of Treatment Approaches in AChR-Antibody Positive Generalized Myasthenia Gravis in Russia is a Not Applicable clinical trial sponsored by AstraZeneca studying Rare Diseases, Generalized Myasthenia Gravis (gMG). This study observes how generalized myasthenia gravis (gMG) is treated in Russia. It is for adults diagnosed with gMG who have specific antibodies (AChR-positive). Participation involves reviewing existing medical records and potentially some future data collection. There are no new treatments being tested; it's an observational study. The trial aims to enroll 450 participants.
Official 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults aged 18 and older with generalized myasthenia gravis and positive AChR antibodies can join. You cannot join if you are currently in another gMG treatment study. Individuals with only ocular myasthenia gravis (affecting only the eyes) cannot participate. This trial is studying Rare Diseases, Generalized Myasthenia Gravis (gMG), so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The study will look at how patients' symptoms and daily functioning change over time, measured by scores on specific questionnaires, to understand treatment effectiveness. The specific primary outcome measures are: Age at baseline (years) (Baseline (Month 0; at informed consent and enrollment)); Age at gMG diagnosis (years) (Baseline (retrospective abstraction at Month 0)); Sex and ethnicity distribution (Baseline (Month 0)); Body Mass Index (BMI) (Baseline (Month 0; last available measurements closest to ICF signing)); Disease duration (days) (Baseline (Month 0)). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial is important because it will provide a clearer picture of how gMG is managed in Russia, helping to identify unmet needs and improve care. This research targets Rare Diseases, Generalized Myasthenia Gravis (gMG), where improved treatment options are needed.
Investor Insight
This observational study provides valuable real-world data on gMG treatment patterns in Russia, which can inform future drug development and market strategies for AstraZeneca.
Is This Trial Right for Me?
Ask your doctor if your current treatment aligns with typical approaches for AChR-positive gMG in Russia. Participation involves reviewing your past and potentially future medical information related to your gMG. The study aims to understand your treatment journey without changing your current care. This trial is currently recruiting participants. The trial is being conducted at 3 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: OBSERVATIONAL
- Enrollment: 450 participants
Primary Outcomes
- Age at baseline (years) (Baseline (Month 0; at informed consent and enrollment))
- Age at gMG diagnosis (years) (Baseline (retrospective abstraction at Month 0))
- Sex and ethnicity distribution (Baseline (Month 0))
- Body Mass Index (BMI) (Baseline (Month 0; last available measurements closest to ICF signing))
- Disease duration (days) (Baseline (Month 0))
Secondary Outcomes
- 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))
Full 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.
Trial Locations
- Research Site, Kazan', Russia
- Research Site, Novosibirsk, Russia
- Research Site, Rostov-on-Don, Russia
Frequently Asked Questions
What is clinical trial NCT07247279?
NCT07247279 is a Not Applicable OBSERVATIONAL study titled "Epidemiological Study of Treatment Approaches in AChR-Antibody Positive Generalized Myasthenia Gravis in Russia." It is currently recruiting and is sponsored by AstraZeneca. The trial targets enrollment of 450 participants.
What conditions does NCT07247279 study?
This trial investigates treatments for Rare Diseases, Generalized Myasthenia Gravis (gMG). The primary condition under study is Rare Diseases.
What does Not Applicable mean for NCT07247279?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT07247279?
This trial is currently "Recruiting." It started on 2025-12-23. The estimated completion date is 2029-12-31.
Who is sponsoring NCT07247279?
NCT07247279 is sponsored by AstraZeneca. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07247279?
The trial aims to enroll 450 participants. The trial is currently recruiting and accepting new participants.
How is NCT07247279 designed?
This is a observational study.
What are the primary outcomes being measured in NCT07247279?
The primary outcome measures are: Age at baseline (years) (Baseline (Month 0; at informed consent and enrollment)); Age at gMG diagnosis (years) (Baseline (retrospective abstraction at Month 0)); Sex and ethnicity distribution (Baseline (Month 0)); Body Mass Index (BMI) (Baseline (Month 0; last available measurements closest to ICF signing)); Disease duration (days) (Baseline (Month 0)). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07247279 being conducted?
This trial is being conducted at 3 sites, including Kazan'; Novosibirsk; Rostov-on-Don (Russia).
Where can I find official information about NCT07247279?
The official record for NCT07247279 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07247279. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07247279 testing in simple terms?
This study observes how generalized myasthenia gravis (gMG) is treated in Russia. It is for adults diagnosed with gMG who have specific antibodies (AChR-positive).
Why is this trial significant?
This trial is important because it will provide a clearer picture of how gMG is managed in Russia, helping to identify unmet needs and improve care.
What are the potential risks of participating in NCT07247279?
As this is an observational study, direct risks from participation are minimal. Potential risks are related to the natural progression of gMG or side effects from your current treatments. Data privacy and confidentiality will be maintained throughout the study. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07247279?
Ask your doctor if your current treatment aligns with typical approaches for AChR-positive gMG in Russia. Participation involves reviewing your past and potentially future medical information related to your gMG. The study aims to understand your treatment journey without changing your current care. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07247279 signal from an investment perspective?
This observational study provides valuable real-world data on gMG treatment patterns in Russia, which can inform future drug development and market strategies for AstraZeneca. This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves reviewing existing medical records and potentially some future data collection. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.