An observational study in Myasthenia Gravis, sponsored by Vitaccess Ltd. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-03.
Sponsored by Vitaccess Ltd · Observational
Among 40 studies in Myasthenia Gravis with a site in United Kingdom — 10 open to participants now, 21 under way, 15 of them phase 3. Myasthenia Gravis · United Kingdom.
Among the 40 studies in Myasthenia Gravis with a site in United Kingdom, this one is one of 6 that started in 2019, is one of 4 observational ones, and was the 13th registered.
330 studies on the registry are indexed under Myasthenia Gravis; 144 are open to participants now.
Browse Myasthenia Gravis studies →10 of the 40 studies in Myasthenia Gravis with a site in United Kingdom are open now. Recruiting first, the newest first:
Amgen · Sites in United Kingdom, United States, Argentina and 5 more countries
Ages 2–17
Immunovant Sciences GmbH · Sites in United Kingdom, United States, Argentina and 12 more countries
Ages 18–80
Alexion Pharmaceuticals, Inc. · Sites in United Kingdom, United States, Australia and 4 more countries
Women only
UCB Biopharma SRL · Sites in United Kingdom, United States, Italy and 2 more countries
Ages 12–17
Kyverna Therapeutics · Sites in United Kingdom, United States, Australia and 3 more countries
Ages 18–75
A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →
Of the 104 Myasthenia Gravis studies recruiting now, 64 (62%) set no upper age limit and 23 (22%) stop at 75 or younger; 16 take children under 18; 13 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
40 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 11 · Phase 3 28
First in 2004; this study’s year is marked. 6 started in 2019.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 2,847 is above the median of 130 across 105 observational studies indexed under Myasthenia Gravis.
Median enrollment 120 across the 36 interventional studies, 418 across the 4 observational. Of the 19 that completed or were terminated, 12 (63%) have results posted.
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38 of 40 have an industry lead sponsor. The 10 most frequent:
Vitaccess Ltd is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
Vitaccess Ltd has 2 studies filed under Myasthenia Gravis — fewer than ten, so there is no comparison to draw.
8 of the studies in Myasthenia Gravis with a site in United Kingdom that are under way reach primary completion within a year, 7 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06799247Phase 3Cartesian TherapeuticsInvestigating an mRNA CAR T-cell Therapy, Known as Descartes-08, as a Potential Approach to Treat Myasthenia Gravis | 2026-12-30 |
| NCT04833894Phase 3argenxEvaluating the Pharmacokinetics, Pharmacodynamics, and Safety of Efgartigimod Administered Intravenously in Children With Generalized Myasthenia Gravis | 2027-03 |
| NCT06517758Phase 3Novartis PharmaceuticalsA Phase III Study to Investigate Efficacy, Safety and Tolerability of Iptacopan Compared With Placebo in Participants Aged 18 to 85 Years With gMG. | 2027-04-30 |
| NCT06055959Phase 3UCB Biopharma SRLA Study to Evaluate Subcutaneous Zilucoplan in Pediatric Participants With Generalized Myasthenia Gravis | 2027-05-12 |
| NCT06392386Phase 3argenxA Study of Efgartigimod PH20 SC in Children Between 2 and Less Than 18 Years of Age With Generalized Myasthenia Gravis | 2027-09 |
Add all 8 to your calendar (.ics) → With an account.
Among the 40 studies in Myasthenia Gravis with a site in United Kingdom, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Data was collected from people with MG using the MyRealWorld™ RWE platform , developed by the healthcare digital research company, Vitaccess. Participants downloaded a 'bring your own device' (BYOD) study app, MyRealWorld™ MG, onto their smartphones, which they used to enter data and complete surveys about their MG.
Adults (age >18 years) with any stage and any subtype of myasthenia gravis disease
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Change in EuroQol 5-dimension 5-level (EQ-5D-5L) score
The EQ-5D-5L comprises two parts - the EQ-5D-5L descriptive system and the EQ Visual Analogue Scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, and anxiety/depression), each with 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems - i.e., higher scores represent worse health). The digits for 5 dimensions can be combined in a 5-digit number describing the respondent's health state. The EQ VAS records the respondent's self-rated health on vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'. Higher scores represent better self-perceived health.
Time frame: Monthly throughout 2 year study duration
Change in Myasthenia Gravis Activities of Daily Living (MG-ADL) score
The MG-ADL is a myasthenia gravis-specific 8-item scale, which assesses the severity of the following symptoms: talking, chewing, swallowing, breathing, impairment of ability to brush teeth/comb hair, impairment of ability to rise from a chair, double vision, and eyelid droop. Each of the 8 items has 4 response options; 0 (Mild), 1 (Moderate), 2 (Mild) and 3 (Severe). The MG-ADL total score can be calculated by totalling all 8 items out of a maximum score of 24. A higher score indicates severe impairment.
Time frame: Four times per six months throughout 2 year study duration
Change in Myasthenia Gravis Quality of Life 15-item revised scale (MG-QoL15r) score
The MG-QOL15r is a myasthenia gravis-specific health-related quality of life survey, which assesses the impact of myasthenia gravis over the past few weeks on the following domains: emotions, physical health, self-care, social life, and impact on role. Each of the 15 items has three response options: 0 (Not at all), 1 (Somewhat), and 2 (Very much). The MG-QoL15r total score can be calculated by totalling all 15 items out a maximum score of 30. A higher score indicates severe impairment.
Time frame: Once per six months throughout 2 year study duration
Change in Hospital Anxiety and Depression Scale (HADS) score
The HADS is a frequently used self-rating scale developed to assess psychological distress in non-psychiatric patients. It consists of two subscales, Anxiety and Depression. The instrument comprises 14 items, 7 for the anxiety subscale and 7 for the depression subscale. Each item is scored on a 4-point response scale, scale wording changes for each item with each coding response corresponding with greater impairment or severity. Domain scores can be calculated by totalling all 7 items out of a maximum score of 21. High scores indicate greater severity of that impairment
Time frame: Once per six months throughout 2 year study duration
Change in Health Utilities Index III (HUI3) score
The HUI3 is a generic 8-item survey, which provides descriptive evidence on multiple dimensions of health status, a score for each dimension of health, and a health-related quality of life score for overall health.Health dimensions include vision, hearing, speech, ambulation/mobility, pain, dexterity, emotion and cognition. Each dimension has five or six response options. It has recall periods of either 'usual health', the past week, two weeks, or four weeks. Scores on individual items are combined to given a combined health state which can then be converted to health utilities. Lower health utilities represent worse health.
Time frame: Once per 12 months throughout 2 year study duration
COVID-19 survey results
This is a bespoke survey designed to understand the impact of COVID-19 on study participants. It includes questions about whether participants have had COVID, and the consequences if so, whether they have been vaccinated, and how the wider pandemic has affected their MG treatment and quality of life.
Time frame: Monthly throughout 2 year study duration
Change in Single Simple Question (SSQ) and Patient Acceptable Symptom States (PASS) scores
The SSQ is a single question that asks respondents what percentage of normal they feel with respect to their MG. The PASS is a single question that asks respondents whether they would consider their current disease state to be satisfactory if they had to stay in it for the next few months. The SSQ and PASS will be presented to participants at the same time, as a question pair.
Time frame: Four times per six months throughout 2 year study duration
Change in EuroQol 5-dimension 3-level (EQ-5D-3L) score
The EQ-5D-3L is a three-level version of the EQ-5D-5L. It includes the same dimensions as the EQ-5D-5L, but each has only three levels: no problems, some problems, and extreme problems. The EQ VAS is unchanged from the EQ-5D-5L version.
Time frame: Monthly for three months for participants from the US and Italy only
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Dyspnea Characteristics score
The PROMIS sleep disturbance measure assesses self-reported frequency, severity, and duration of dyspnea (shortness of breath) over the last 7 days using either a 0-10 numeric rating scale or 0-4 rating scale to assess dyspnea characteristics.Each item is evaluated individually according to the numeric rating scale. No total score is calculated for this instrument. Higher scores on items indicate more severe symptoms.
Time frame: Once per six months throughout 2 year study duration
Change in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score
The FACIT-Fatigue measure is a generic 13-item survey which assesses fatigue levels and impact over the past 7 days. The level of fatigue is measured on a 4-point Likert scale (4 = not at all fatigue to 0 = very much fatigued). Scores range from 0-52. The higher the score, the better the quality of life.
Time frame: Once per six months throughout 2 year study duration
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance short form 6a change
The PROMIS sleep disturbance measure assesses self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep over the last 7 days using a 5-point scale. Scores range from 6-30. Higher scores represent worse sleep disturbance.
Time frame: Once per six months throughout 2 year study duration
Plan to share: No — Aggregated data may be available via application.
Ran from Dec 2019 to primary completion in May 2024, 53 months.
Of 62 observational studies under Myasthenia Gravis, half reached primary completion within 52 months of starting (the median), counting those still running; a quarter within 24. This study's 53 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Vitaccess Ltd