CompletedNot Applicable

The Impact of Myasthenia Gravis in the Real World

United Kingdom2,847 participantsStarted 2019-12-12

Plain-language summary

An international, non-interventional, prospective, community recruited, longitudinal, lifestyle study which aims to collect Real-World Evidence (RWE) from people living with myasthenia gravis (MG) in order to map the disease's natural history, its burden on patients and their families, its treatment, as well as its medical, social and pharmacoeconomic impact.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adults (aged 18 years and over) with any stage and any subtype of myasthenia gravis disease * Resident in Belgium, Canada, France, Germany, Italy, Japan, Spain, the UK, the USA, or Denmark Exclusion Criteria: * No specific exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in EuroQol 5-dimension 5-level (EQ-5D-5L) score

Timeframe: Monthly throughout 2 year study duration

Change in Myasthenia Gravis Activities of Daily Living (MG-ADL) score

Timeframe: Four times per six months throughout 2 year study duration

Change in Myasthenia Gravis Quality of Life 15-item revised scale (MG-QoL15r) score

Timeframe: Once per six months throughout 2 year study duration

Change in Hospital Anxiety and Depression Scale (HADS) score

Timeframe: Once per six months throughout 2 year study duration

Change in Health Utilities Index III (HUI3) score

Timeframe: Once per 12 months throughout 2 year study duration

COVID-19 survey results

Timeframe: Monthly throughout 2 year study duration

Change in Single Simple Question (SSQ) and Patient Acceptable Symptom States (PASS) scores

Trial details

NCT IDNCT04176211

SponsorVitaccess Ltd

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-05-31

View on ClinicalTrials.gov More Myasthenia Gravis trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in EuroQol 5-dimension 5-level (EQ-5D-5L) score

Timeframe: Monthly throughout 2 year study duration

Change in Myasthenia Gravis Activities of Daily Living (MG-ADL) score

Timeframe: Four times per six months throughout 2 year study duration

Change in Myasthenia Gravis Quality of Life 15-item revised scale (MG-QoL15r) score

Timeframe: Once per six months throughout 2 year study duration

Change in Hospital Anxiety and Depression Scale (HADS) score

Timeframe: Once per six months throughout 2 year study duration

Change in Health Utilities Index III (HUI3) score

Timeframe: Once per 12 months throughout 2 year study duration

COVID-19 survey results

Timeframe: Monthly throughout 2 year study duration

Change in Single Simple Question (SSQ) and Patient Acceptable Symptom States (PASS) scores