Trial · NCT04818671
Outcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of AEs, SAEs and AESIs | Up to 3.5 years | Safety analysis set: all participants who were exposed to efgartigimod PH20 SC in this study | events | NUMBER |
| SECONDARY | MG-ADL Total Score Changes From Baseline | Up to week 4 of the first cycle | Safety analysis set: all participants who were exposed to efgartigimod PH20 SC in this study. Only participants with an assessment at baseline and the respective weeks of first cycle are reported in each row. | score on a scale | MEAN |
| SECONDARY | Percent Change in Total IgG Levels From Baseline | Up to week 4 of the first cycle | Safety analysis set: all participants who were exposed to efgartigimod PH20 SC in this study. Only participants with an assessment at baseline and week 4 of the first cycle are reported. | Percent change | MEAN |
| SECONDARY | Percent Change in AChR-Ab From Baseline in AChR-Ab Seropositive Participants | Up to week 4 of the first cycle | Safety analysis set: all participants who were exposed to efgartigimod PH20 SC in this study. Only participants with an assessment at baseline and week 4 of the first cycle are reported. | Percent change | MEAN |
| SECONDARY | Efgartigimod Serum Concentrations | Up to week 4 of the first cycle | Safety analysis set: all participants who were exposed to efgartigimod PH20 SC in this study. Only participants with an assessment at baseline and week 4 of the first cycle are reported. | ng/mL | MEAN |
| SECONDARY | Incidence of ADAs Against Efgartigimod Over Time | Up to 3.5 years | Safety analysis set: all participants who were exposed to efgartigimod PH20 SC in this study. The number analyzed is the total number of ADA evaluable participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Incidence of NAbs Against Efgartigimod Over Time | Up to 3.5 years | Safety analysis set: all participants who were exposed to efgartigimod PH20 SC in this study. The number analyzed is the total number of NAb-evaluable participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Incidence of Antibodies Against rHuPH20 Over Time | Up to 3.5 years | Safety analysis set: all participants who were exposed to efgartigimod PH20 SC in this study. The number analyzed is the total number of rHuPH20 Ab evaluable participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Incidence of NAbs Against rHuPH20 Over Time | Up to 3.5 years | Safety analysis set: all participants who were exposed to efgartigimod PH20 SC in this study. The number analyzed is the total number of rHuPH20 NAb-evaluable participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Changes in Total MG-QoL15r From Baseline | Up to week 4 of the first cycle | Safety analysis set: all participants who were exposed to efgartigimod PH20 SC in this study. Only participants with an assessment at baseline and the respective weeks of first cycle are reported in each row. | score on a scale | MEAN |
| SECONDARY | Changes in EQ-5D-5L VAS Score From Baseline | Up to week 4 of the first cycle | Safety analysis set: all participants who were exposed to efgartigimod PH20 SC in this study. Only participants with an assessment at baseline and week 4 of the first cycle are reported. | score on a scale | MEAN |
| SECONDARY | Percent of Participants or Caregivers by Number of Training Visits Needed to be Competent to Start Self- or Caregiver-Supported Administration | Up to 3.5 years | Safety analysis set: all participants who were exposed to efgartigimod PH20 SC in this study. The number analyzed is the total number of participants adequately trained and capable of doing self- or caregiver-supported administrations. | Percent of participants | NUMBER |
| SECONDARY | Percent of Self- or Caregiver-supported Study Drug Administration Among All Study Treatment Visits at Home | Up to 3.5 years | Safety analysis set: all participants who were exposed to efgartigimod PH20 SC in this study. | Percent | NUMBER |
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.
For software
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GET https://conductscience.org/api/trials/v1/NCT04818671/outcomes