Myasthenia GravisMya-BoDNCT03979521
Burden of Disease in Myasthenia Gravis
An observational study of Myasthenia Gravis, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Questionnaire-based survey addressed to german patients with the chronic autoimmune muscle disease called myasthenia gravis regarding quality of life, socioeconomic impact, social support, course of disease, complications of therapy and psychological comorbidities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myasthenia Gravis
- How many people
- 1,680 participants
- Where
- 1 siteGermany
- Study dates
- 1 May 2019to 31 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Myasthenia Gravis being member at the German myasthenia gravis socitey (Deutsche Myasthenie Gesellschaft)
Who may be able to join
- Patients with Myasthenia Gravis
- Age ≥18 years
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Germany1 site
NeuroCure Clinical Research Center (NCRC), Charité University, Berlin
Mitte
About this study
Official title: Questionnaire Survey on the Systematic Recording and Characterization of Quality of Life Limitations in Myasthenia Gravis
Questionnaire-based survey addressed to german patients with the chronic autoimmune muscle disease called myasthenia gravis regarding quality of life, socioeconomic impact, social support, course of disease, complications of therapy and psychological comorbidities.
Read the detailed description
Background:
Myasthenia gravis is a rare, chronic, antibody-mediated autoimmune disease that results in muscular weakness. The patients suffer from symptoms such as visual disturbances (especially double vision), weakness in the arms and legs, chewing and swallowing disorders and respiratory disorders, as well as crisis-related worsening of ventilation. This is often accompanied by pronounced fatigue (physical) and mental fatigue (depression).
Despite drug therapies that are on one hand symptomatic improving muscle strength, and on the other hand modulating the immune system, as well as specific procedures and drugs used in crises (plasmapheresis, immunoglobins) or refractory patients, patients are often severely limited, affecting everyday activities of self-care, family, social and professional life, thus affecting the mood and quality of life of patients. There is a lack of data measuring quality of life adequately.
Aim:
The aim of the data collection is to record the quality of life of myasthenia patients. By clinical information on the disease (including symptoms, course and therapy) and recording the social and occupational situation, the data should be contextualized. The following hypotheses are to be confirmed:
Primary hypotheses
- Myasthenia gravis affects the quality of life of patients comparable to neurological diseases such as multiple sclerosis
- Patients are limited in their participation in their private and professional life
- The severity of the disease is associated with the quality of life. Secondary hypotheses
- Myasthenia is associated with income busses and other economic disadvantages of the night
- Quality of life in myasthenia patients is related to fatigue and depression
- Quality of life in myasthenia patients depends on different therapy methods
- Myasthenia gravis has an impact on family planning and care for children.
Methods:
In cooperation with the German Myasthenia Gravis Society, a questionnaire prepared by the Charité will be sent to its members with a request for completion and an anonymous return. Similar projects have already been implemented in the past (response rate> 30%). About 3,300 patients should be contacted.
The returned questionnaires are then statistically evaluated and presented as part of a publication. For the evaluation of the hypotheses suitable descriptive, univariate analysis methods are used. Furthermore, with sufficient case numbers, multivariate analyzes (e.g., logistic regression) are also planned.
The questionnaire contains general information and questions about:
- Education and employment
- Social situation
- Social Support
- Economic aspects
- Symptoms and severity, course, treatment of myasthenia
- Quality of life
- Fatigue and depression
- Conditions
- Myasthenia Gravis
- Keywords
- Myasthenia Gravis, Quality of life, Burden of disease, Social support
- Medical subject headings
- Myasthenia Gravis
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire for self-completion by patients containing questions about general information, information on myasthenia, information socioeconomic situation
Measured: directly after inclusion in the study
Hospital Anxiety and Depression Scale (HADS)
Questionnaire for self-completion by patients to determine the levels of anxiety and depression
Measured: directly after inclusion in the study
Mya Quality of Life 15 (Mya QoL15)
Questionnaire for self-completion by patients for use as a measure of health outcome
Measured: directly after inclusion in the study
Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF36)
Questionnaire for self-completion by patients for patients health
Measured: directly after inclusion in the study
Myasthenia gravis Activities of daily living (MG ADL)
Questionnaire for self-completion by patients to determine symptom severity and limitations in activities of daily living
Measured: directly after inclusion in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start1 May 2019
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Myasthenia GravisStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,680 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- NeuroCure Clinical Research Center, Charite, Berlin
- Responsible party
- Principal investigator, Andreas Meisel, Charite University, Berlin, Germany
- Investigators
- Andreas Meisel, Prof. Dr. med., Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03979521
- Sponsor's protocol ID
- Mya-BoD
- Acronym
- Mya-BoD
- Status last verified
- Dec 2021
- First submitted
- 4 Jun 2019
- Last updated
- 4 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lehnerer S, Jacobi J, Schilling R, Grittner U, Marbin D, Gerischer L, Stascheit F, Krause M, Hoffmann S, Meisel A. Burden of disease in myasthenia gravis: taking the patient's perspective. J Neurol. 2022 Jun;269(6):3050-3063. doi: 10.1007/s00415-021-10891-1. Epub 2021 Nov 20.
PubMed 34800167Lehnerer S, Stegherr R, Grittner U, Stein M, Gerischer L, Stascheit F, Herdick M, Doksani P, Meisel A, Hoffmann S. The burden of disease in seronegative myasthenia gravis: a patient-centered perspective. Front Immunol. 2025 Apr 8;16:1555075. doi: 10.3389/fimmu.2025.1555075. eCollection 2025.
PubMed 40264778Lehnerer S, Herdick M, Mevius A, Grittner U, Gansel P, Joeres L, Biskup J, Meisel A. The economic burden of Myasthenia gravis from the patient s perspective and reflected in German claims data. Sci Rep. 2025 Feb 25;15(1):6687. doi: 10.1038/s41598-025-91372-7.
PubMed 39994434Stein M, Grittner U, Stegherr R, Gerischer L, Stascheit F, Hoffmann S, Herdick M, Legg D, Marbin D, Meisel A, Lehnerer S. The burden of myasthenia gravis - highlighting the impact on family planning and the role of social support. Front Neurol. 2023 Dec 14;14:1307627. doi: 10.3389/fneur.2023.1307627. eCollection 2023.
PubMed 38162439
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Questionnaire Survey on the Systematic Recording and Characterization of Quality of Life Limitations in Myasthenia Gravis
- ClinicalTrials.gov ID
- NCT03979521
- Acronym / sponsor ID
- Mya-BoD / Mya-BoD
- Conditions
- Myasthenia Gravis
- Keywords
- Myasthenia Gravis, Quality of life, Burden of disease, Social support
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,680 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- NeuroCure Clinical Research Center, Charite, Berlin
- Study start
- 1 May 2019 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 7 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Questionnaire-based survey addressed to german patients with the chronic autoimmune muscle disease called myasthenia gravis regarding quality of life, socioeconomic impact, social support, course of disease, complications of therapy and psychological comorbidities.
Detailed description
Background:
Myasthenia gravis is a rare, chronic, antibody-mediated autoimmune disease that results in muscular weakness. The patients suffer from symptoms such as visual disturbances (especially double vision), weakness in the arms and legs, chewing and swallowing disorders and respiratory disorders, as well as crisis-related worsening of ventilation. This is often accompanied by pronounced fatigue (physical) and mental fatigue (depression).
Despite drug therapies that are on one hand symptomatic improving muscle strength, and on the other hand modulating the immune system, as well as specific procedures and drugs used in crises (plasmapheresis, immunoglobins) or refractory patients, patients are often severely limited, affecting everyday activities of self-care, family, social and professional life, thus affecting the mood and quality of life of patients. There is a lack of data measuring quality of life adequately.
Aim:
The aim of the data collection is to record the quality of life of myasthenia patients. By clinical information on the disease (including symptoms, course and therapy) and recording the social and occupational situation, the data should be contextualized. The following hypotheses are to be confirmed:
Primary hypotheses
- Myasthenia gravis affects the quality of life of patients comparable to neurological diseases such as multiple sclerosis
- Patients are limited in their participation in their private and professional life
- The severity of the disease is associated with the quality of life. Secondary hypotheses
- Myasthenia is associated with income busses and other economic disadvantages of the night
- Quality of life in myasthenia patients is related to fatigue and depression
- Quality of life in myasthenia patients depends on different therapy methods
- Myasthenia gravis has an impact on family planning and care for children.
Methods:
In cooperation with the German Myasthenia Gravis Society, a questionnaire prepared by the Charité will be sent to its members with a request for completion and an anonymous return. Similar projects have already been implemented in the past (response rate> 30%). About 3,300 patients should be contacted.
The returned questionnaires are then statistically evaluated and presented as part of a publication. For the evaluation of the hypotheses suitable descriptive, univariate analysis methods are used. Furthermore, with sufficient case numbers, multivariate analyzes (e.g., logistic regression) are also planned.
The questionnaire contains general information and questions about:
- Education and employment
- Social situation
- Social Support
- Economic aspects
- Symptoms and severity, course, treatment of myasthenia
- Quality of life
- Fatigue and depression
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Myasthenia Gravis being member at the German myasthenia gravis socitey (Deutsche Myasthenie Gesellschaft)
Key inclusion criteria (2 listed)
- Patients with Myasthenia Gravis
- Age ≥18 years
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Questionnaire for self-completion by patients containing questions about general information, information on myasthenia, information socioeconomic situation
Time frame: directly after inclusion in the study
Hospital Anxiety and Depression Scale (HADS)
Time frame: directly after inclusion in the study
Questionnaire for self-completion by patients to determine the levels of anxiety and depression
Mya Quality of Life 15 (Mya QoL15)
Time frame: directly after inclusion in the study
Questionnaire for self-completion by patients for use as a measure of health outcome
Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF36)
Time frame: directly after inclusion in the study
Questionnaire for self-completion by patients for patients health
Myasthenia gravis Activities of daily living (MG ADL)
Time frame: directly after inclusion in the study
Questionnaire for self-completion by patients to determine symptom severity and limitations in activities of daily living
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
- Results publication: PubMed 34800167Lehnerer S, Jacobi J, Schilling R, Grittner U, Marbin D, Gerischer L, Stascheit F, Krause M, Hoffmann S, Meisel A. Burden of disease in myasthenia gravis: taking the patient's perspective. J Neurol. 2022 Jun;269(6):3050-3063. doi: 10.1007/s00415-021-10891-1. Epub 2021 Nov 20.
- Derived from this study: PubMed 40264778Lehnerer S, Stegherr R, Grittner U, Stein M, Gerischer L, Stascheit F, Herdick M, Doksani P, Meisel A, Hoffmann S. The burden of disease in seronegative myasthenia gravis: a patient-centered perspective. Front Immunol. 2025 Apr 8;16:1555075. doi: 10.3389/fimmu.2025.1555075. eCollection 2025.
- Derived from this study: PubMed 39994434Lehnerer S, Herdick M, Mevius A, Grittner U, Gansel P, Joeres L, Biskup J, Meisel A. The economic burden of Myasthenia gravis from the patient s perspective and reflected in German claims data. Sci Rep. 2025 Feb 25;15(1):6687. doi: 10.1038/s41598-025-91372-7.
- Derived from this study: PubMed 38162439Stein M, Grittner U, Stegherr R, Gerischer L, Stascheit F, Hoffmann S, Herdick M, Legg D, Marbin D, Meisel A, Lehnerer S. The burden of myasthenia gravis - highlighting the impact on family planning and the role of social support. Front Neurol. 2023 Dec 14;14:1307627. doi: 10.3389/fneur.2023.1307627. eCollection 2023.
Related trials for Myasthenia Gravis
Active, not recruitingPhase 3
An Extension Study Evaluating 6-week Treatment Cycles of Rozanolixizumab in Pediatric Study Participants With Generalized Myasthenia Gravis
Generalized Myasthenia Gravis
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis
Ocular Myasthenia Gravis
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
RecruitingPhase 3
A Study to Evaluate The Long-Term Safety And Efficacy of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis
Ocular Myasthenia Gravis
Recruiting
Holistic Assessment and Remote Digital MONitoring of mYasthenia Gravis Via MyoSense 360
Myasthenia Gravis, Generalized
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Meisel, Prof. Dr. med. principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myasthenia Gravis, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire for self-completion by patients containing questions about general information, information on myasthenia, information socioeconomic situation (time frame: directly after inclusion in the study). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03979521, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2022.