NCT03979521

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,680

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 4, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 7, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

January 4, 2022

Status Verified

December 1, 2021

Enrollment Period

3 months

First QC Date

June 4, 2019

Last Update Submit

December 15, 2021

Conditions

Myasthenia Gravis

Keywords

Myasthenia GravisQuality of lifeBurden of diseaseSocial support

Outcome Measures

Primary Outcomes (5)

  • Questionnaire for self-completion by patients containing questions about general information, information on myasthenia, information socioeconomic situation

    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

    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

    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

    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

    directly after inclusion in the study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with Myasthenia Gravis being member at the German myasthenia gravis socitey (Deutsche Myasthenie Gesellschaft)

You may qualify if:

  • Patients with Myasthenia Gravis
  • Age ≥18 years

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NeuroCure Clinical Research Center (NCRC), Charité University, Berlin

Mitte, Germany

Location

Related Publications (4)

  • 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.

    PMID: 34800167RESULT

  • Lehnerer 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.

    PMID: 40264778DERIVED

  • Lehnerer 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.

    PMID: 39994434DERIVED

  • Stein 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.

    PMID: 38162439DERIVED

MeSH Terms

Conditions

Myasthenia Gravis

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous SystemNervous System NeoplasmsNeoplasms by SiteNeoplasmsParaneoplastic SyndromesAutoimmune Diseases of the Nervous SystemNervous System DiseasesNeurodegenerative DiseasesNeuromuscular Junction DiseasesNeuromuscular DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Andreas Meisel, Prof. Dr. med.

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

June 4, 2019

First Posted

June 7, 2019

Study Start

May 1, 2019

Primary Completion

July 31, 2019

Study Completion

July 31, 2019

Last Updated

January 4, 2022

Record last verified: 2021-12

Locations

DE(1)