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Trial · NCT04735432

Outcomes14

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYPercent Change From Baseline in Total IgG Levels at Day 29 (mITT Analysis Set)From week 0 to week 4percentLEAST_SQUARES_MEAN
SECONDARYPercent Change From Baseline in Total IgG Levels Over Time (mITT Analysis Set)From baseline to week 10mITT Analysis Set: All randomized participants with a value for total IgG levels at baseline and at least 1 postbaseline timepoint.percentMEAN
SECONDARYPercent Change From Baseline in AChR-Ab Levels Over Time in AChR- Ab Positive Patients (mITT Analysis Set)From baseline to week 10percentMEAN
SECONDARYPercent Change From Baseline in IgG Subtype Levels Over Time (mITT Analysis Set)Baseline to week 10mITT Analysis Set: All randomized participants with a value for total IgG levels at baseline and at least 1 postbaseline timepoint.Percent changeMEDIAN
SECONDARYAUEC of the Percent Change From Baseline in Total IgG Level (mITT Analysis Set)From baseline to week 10percent daysMEAN
SECONDARYЕfgartigimod IV and PH20 SC Serum Pharmacokinetic Parameter CtroughFrom Week 1 to Week 4.μg/mLMEAN
SECONDARYEfgartigimod IV Serum Pharmacokinetic Parameter CmaxFrom Baseline to Week 3μg/mLMEAN
SECONDARYIncidence of ADA Against Efgartigimod (Safety Analysis Set)From baseline to week 10Percent of patientsNUMBER
SECONDARYIncidence of Antibodies Against rHuPH20 in the SC Treatment Arm (Safety Analysis Set)From baseline to week 10Percent of patientsNUMBER
SECONDARYIncidence and Severity of AEs and SAEs (Safety Analysis Set)From baseline to week 10Percent of patientsNUMBER
SECONDARYMG-ADL Responders (ITT Analysis Set)From baseline to week 10percentNUMBER
SECONDARYQMG Responders (ITT Analysis Set)From Baseline to Week 10One patient from Efgartigimod IV didn't have any post-baseline QMG assessment.percentNUMBER
SECONDARYChange From Baseline in MG-ADL Total Score Over Time (ITT Analysis Set)From baseline to week 10Total score on a scaleMEAN
SECONDARYChange From Baseline in QMG Score Over Time (ITT Analysis Set)From baseline to week 10Total scoreMEAN

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

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNone 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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