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Trial · NCT04346888

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryChange in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score from baseline to Day 4343 days
The MG-ADL profile provides an assessment of MG symptom severity and measures 8 items on a 0-3 scale, with 0 being the least severe. The total sum of the 13 items represents the ADL score. The ADL score can range from 0 (least severe) to 24 (most severe)
SecondaryChange in the Myasthenia Gravis Composite (MGC) score from baseline to Day 4343 days
The total QMG score is obtained by summing the responses to each individual item (13 items; Responses: None=0, Mild=1, Moderate=2, Severe=3). The score ranges from 0 to 39, with lower scores indicating lower disease activity.
SecondaryChange in the Quantitative Myasthenia Gravis (QMG) score from baseline to Day 4343 days
The QMG test is a standardized quantitative strength scoring system and measures 13 items on a 0-3 scale, with 0 being the least severe. The total sum of the 13 items represents the QMG score. The QMG score can range from 0 (least severe) to 39 (most severe).
SecondaryChange in the Myasthenia Gravis Quality of Life 15(MG-QoL15r) score from baseline to Day 4343 days
The MG-QoL 15r scale is a patient-reported score that assesses the patient's perception of impairment and disability and the degree to which the patient tolerates disease manifestations. Each question was graded on a 3-point scale from 0=normal to 2=severe with a score of 0 to 30; the higher score indicates worse MG disease activity
SecondaryProportion of participants with a decrease on the MG-ADL Score by ≥ 2 points from baseline to Day 4343 days
Secondary
Proportion of participants with an improvement and worse on the MGFA Post-intervention Status (MGFA-PIS) from baseline to Day 43. o Improvement: MGC Score reduce ≥ 3 points o Aggravation: MGC Score increase ≥ 3 points
43 days
SecondaryChange in the MG-ADL score from baseline to Day 120120 days
SecondaryChange in the MGC score from baseline to Day 120120 days
SecondaryChange in the QMG score from baseline to Day 120120 days
SecondaryChange in the MG-QoL15r score from baseline to Day 120120 days
SecondaryProportion of participants with persistent improvement on the MGC score from baseline to Day 120120 daysImprovement (decrease) in the MGC score by ≥ 3 points for 6 weeks
SecondaryProportion of participants with persistent improvement on the MG-ADL score from baseline to Day 120120 daysImprovement (decrease) in the MG-ADL Score by ≥ 2 points for 6 weeks

Source ClinicalTrials.govtrials-2026-11-12-0.4.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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