Trial · NCT04818671
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of AEs, SAEs and AESIs | Up to 3.5 years | Adverse events, Serious Adverse event and Adverse events of special interest. Adverse events in the 'Infections and infestations' SOC were defined as AESIs because efgartigimod causes a transient reduction in total IgG levels. |
| Secondary | MG-ADL Total Score Changes From Baseline | Up to week 4 of the first cycle | The Myasthenia Gravis Activities of Daily Living (MG-ADL) is an 8-item patient-reported scale that assesses MG symptoms and their effects on daily activities. It evaluates a participant's capacity to perform different activities in their daily life. The total score ranges from 0 to 24 with higher scores indicating more impairment. |
| Secondary | Percent Change in Total IgG Levels From Baseline | Up to week 4 of the first cycle | IgG: immunoglobulin G |
| Secondary | Percent Change in AChR-Ab From Baseline in AChR-Ab Seropositive Participants | Up to week 4 of the first cycle | AchR-Ab: anti-acetylcholine receptor antibodies. |
| Secondary | Efgartigimod Serum Concentrations | Up to week 4 of the first cycle | |
| Secondary | Incidence of ADAs Against Efgartigimod Over Time | Up to 3.5 years | ADA: Anti-drug antibodies. |
| Secondary | Incidence of NAbs Against Efgartigimod Over Time | Up to 3.5 years | NAbs: neutralizing antibodies |
| Secondary | Incidence of Antibodies Against rHuPH20 Over Time | Up to 3.5 years | |
| Secondary | Incidence of NAbs Against rHuPH20 Over Time | Up to 3.5 years | NAbs: neutralizing antibodies |
| Secondary | Changes in Total MG-QoL15r From Baseline | Up to week 4 of the first cycle | Myasthenia Gravis Quality of Life 15 item scale revised (MG-QoL 15r) scores range from 0 to 30 with a higher score representing more severe symptoms. |
| Secondary | Changes in EQ-5D-5L VAS Score From Baseline | Up to week 4 of the first cycle | EuroQoL 5 Dimensions 5-Level (EQ-5D-5L) visual analog scale (VAS) scores range from 0 to 100 with a higher score representing better health. |
| 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 | |
| Secondary | Percent of Self- or Caregiver-supported Study Drug Administration Among All Study Treatment Visits at Home | Up to 3.5 years |
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
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT04818671/registered