Trial · NCT04833894
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Efgartigimod concentrations as input for compartmental, model-driven analysis to determine (age and size dependency of) Clearance (CL) | up to 26 weeks | Blood samples will be collected from each participant for measurement of serum concentrations of efgartigimod |
| Primary | Efgartigimod concentrations as input for compartmental, model-driven analysis to determine (age and size dependency of) Volume of Distribution (Vd) | up to 26 weeks | Blood samples will be collected from each participant for measurement of serum concentrations of efgartigimod |
| Primary | Total Immunoglobulin G (IgG) levels as input for pharmacokinetics (PK) and pharmacodynamics (PD) modeling analysis | up to 26 weeks | Total Immunoglobulin G levels will be measured from blood samples |
| Primary | Anti-acetylcholine receptors antibodies (AChR-Ab) as input for pharmacokinetics (PK) and pharmacodynamics (PD) modeling analysis | up to 26 weeks | Total Immunoglobulin G (IgG) levels will be measured from blood samples |
| Secondary | Incidence and severity of adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESIs) | up to 28 weeks | |
| Secondary | Efgartigimod serum concentrations from blood samples | up to 26 weeks | |
| Secondary | Absolute values of levels of total Immunoglobulin G (IgG) from blood samples | up to 26 weeks | |
| Secondary | Change from baseline of levels of total Immunoglobulin G (IgG) from blood samples | up to 26 weeks | |
| Secondary | Percentage change from baseline of total Immunoglobulin G (IgG) from blood samples | up to 26 weeks | |
| Secondary | Absolute values of anti-acetylcholine receptor antibodies (AChR-Ab) from blood samples | up to 26 weeks | |
| Secondary | Change from baseline of anti-acetylcholine receptor antibodies (AChR-Ab) from blood samples | up to 26 weeks | |
| Secondary | Percentage change from baseline of anti-acetylcholine receptor antibodies (AChR-Ab) from blood samples | up to 26 weeks | |
| Secondary | Incidence of anti-drug antibodies (ADAs) against efgartigimod in serum samples | up to 28 weeks | |
| Secondary | Prevalence of anti-drug antibodies (ADAs) against efgartigimod in serum samples | up to 28 weeks | |
| Secondary | Absolute values of total Myasthenia Gravis Activity of Daily Living (MG-ADL) score. Total score can range from 0 to 24, with higher total scores indicating more impairment. | up to 26 weeks | |
| Secondary | Change from baseline of total Myasthenia Gravis Activity of Daily Living (MG-ADL) score. Total score can range from 0 to 24, with higher total scores indicating more impairment. | up to 26 weeks | |
| Secondary | Absolute values of total Quantitative Myasthenia Gravis Score (QMG score). The total possible score is 39, where higher total scores indicate more severe impairments. | up to 26 weeks | |
| Secondary | Change from baseline of total Myasthenia Gravis Score (QMG score). The total possible score is 39, where higher total scores indicate more severe impairments. | up to 26 weeks | |
| Secondary | Absolute values of total score EuroQoL 5 Dimensions Youth (EQ-5D-Y) | up to 26 weeks | Description of the participant's health state is done by digits for 5 dimensions combined in a 5-digit number. A unique health state is defined by combining 1 level from each of the 5 dimensions. Each state is referred to in terms of a 5-digit code, whereas code 11111 would indicate no problems in any of the 5 dimensions and 33333 would indicate worst problems in any of the 5 dimensions. |
| Secondary | Change from baseline of total score EuroQoL 5 Dimensions Youth (EQ-5D-Y) | up to 26 weeks | Description of the participant's health state is done by digits for 5 dimensions combined in a 5-digit number. A unique health state is defined by combining 1 level from each of the 5 dimensions. Each state is referred to in terms of a 5-digit code, whereas code 11111 would indicate no problems and 33333 would indicate worst problems in any of the 5 dimensions. |
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.
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GET https://conductscience.org/api/trials/v1/NCT04833894/registered