Clinical trial · Observational
Predictors and Prognostic Factors of Myasthenia Gravis Outcome
NCT05214612CI-TRIAL-00079297unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aims to characterize the clinical features, frequency of different subgroups of MG, and identify predictors of treatment responsiveness among different subgroups of MG. The predictors are including primary outcome (percentage of changes in MG scales at baseline at time of enrollment and after 3 months) and secondary outcome (treatment-related adverse events). Also it aims to determine the frequency of patients with refractory MG. This information will be used to understand the trends and mechanisms of disease relapse, and optimal management strategies.
Conditions
Conditions (12)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Autoimmune Diseases of the Nervous System | — | UNRESOLVED | — |
| Myasthenia Gravis | — | UNRESOLVED | — |
| Myasthenia Gravis, Adult Form | — | UNRESOLVED | — |
| Myasthenia Gravis Crisis | — | UNRESOLVED | — |
| Myasthenia Gravis, Generalized | — | UNRESOLVED | — |
| Myasthenia Gravis, Juvenile Form | — | UNRESOLVED | — |
| Myasthenia Gravis, Ocular | — | UNRESOLVED | — |
| Myasthenia Gravis With Exacerbation (Disorder) | — | UNRESOLVED | — |
| Nervous System Diseases | — | UNRESOLVED | — |
| Neuromuscular Junction Diseases | — | UNRESOLVED | — |
| Thymoma |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Drug treatment of myasthenia gravis and treatment of crisis | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Change in MG-specific Activities of Daily Living scale (MG-ADL).
- timeFrame
- The changes in points from baseline assessment score to 3 months follow up assessment score
- description
- The MG Activities of Daily Living (MG- ADL) Scale an easily administered, 8-item questionnaire. Each item is graded on a 4- point symptom severity scale (0 = normal, 3 = most severe), with the total score ranging from 0 to 24. Test items emphasize the functional impact of muscle weakness (eg, the ability to comb one's hair or brush one's teeth instead of hand grip or outstretched arm strength tests) rather than its quantitation. The MG-ADL requires no special equipment or training and can be administered in 10 minutes. The MG-ADL test domains include ocular (2 items), oropharyngeal (3 items), respiratory (1 item), and extremity/limb (2 items).
- measure
- Change in MG quality of life 15 (MG-QOL15).
- timeFrame
- The changes in points from baseline assessment score to 3 months follow up assessment score
- description
- Everyday clinical use led to the development of an abbreviated 15-item version, the MG-QOL15. These 15 items were derived from the mobility (9 items), symptoms (3 items), general contentment (1 item), and emotional well-being (2 items) domains of the 60-item version. Each of the items/statements (eg, "I have limited my social activity because of my condition") is scored by patients on a 5-point scale ranging from 0 ("not at all") to 4("very much") based on their experience over the previous 4 weeks; the item scores are summed to generate a total score ranging from 0 to 60.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age from 16 years and older. 2. Gender: both sexes are included. 3. Clinical Diagnosis of MG with supporting evidence as: 1. unequivocal clinical response to pyridostigmine 2. decrement \>10% in repetitive nerve stimulations study (RNS). 4. Willingness to sample collection, imaging study and other disease-related examinations and assessments. Exclusion Criteria: 1. Age younger than 16 years. 2. History of chronic psychiatric or neurological disorder other than MG that can produce weakness or fatigue. 3. Severe systemic illness affecting life-expectancy.
References
Publications (9)
- BACKGROUNDGilhus NE. Myasthenia Gravis. N Engl J Med. 2016 Dec 29;375(26):2570-2581. doi: 10.1056/NEJMra1602678. No abstract available. PMID 28029925
- BACKGROUNDSanders DB, Wolfe GI, Benatar M, Evoli A, Gilhus NE, Illa I, Kuntz N, Massey JM, Melms A, Murai H, Nicolle M, Palace J, Richman DP, Verschuuren J, Narayanaswami P. International consensus guidance for management of myasthenia gravis: Executive summary. Neurology. 2016 Jul 26;87(4):419-25. doi: 10.1212/WNL.0000000000002790. Epub 2016 Jun 29. PMID 27358333
- BACKGROUNDEvoli A. Myasthenia gravis: new developments in research and treatment. Curr Opin Neurol. 2017 Oct;30(5):464-470. doi: 10.1097/WCO.0000000000000473. PMID 28654435
- BACKGROUNDGilhus NE, Tzartos S, Evoli A, Palace J, Burns TM, Verschuuren JJGM. Myasthenia gravis. Nat Rev Dis Primers. 2019 May 2;5(1):30. doi: 10.1038/s41572-019-0079-y. PMID 31048702
- BACKGROUNDLascano AM, Lalive PH. Update in immunosuppressive therapy of myasthenia gravis. Autoimmun Rev. 2021 Jan;20(1):102712. doi: 10.1016/j.autrev.2020.102712. Epub 2020 Nov 13. PMID 33197578
- BACKGROUNDSuh J, Goldstein JM, Nowak RJ. Clinical characteristics of refractory myasthenia gravis patients. Yale J Biol Med. 2013 Jun 13;86(2):255-60. Print 2013 Jun. PMID 23766745
- BACKGROUNDSilvestri NJ, Wolfe GI. Treatment-refractory myasthenia gravis. J Clin Neuromuscul Dis. 2014 Jun;15(4):167-78. doi: 10.1097/CND.0000000000000034. PMID 24872217
- BACKGROUNDAnil R, Kumar A, Alaparthi S, Sharma A, Nye JL, Roy B, O'Connor KC, Nowak RJ. Exploring outcomes and characteristics of myasthenia gravis: Rationale, aims and design of registry - The EXPLORE-MG registry. J Neurol Sci. 2020 Jul 15;414:116830. doi: 10.1016/j.jns.2020.116830. Epub 2020 Apr 16.