Trial · NCT06436742
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Assessment of adverse events (AEs) | Up to week 42 | |
| Primary | Change from active-treatment baseline over time for 6MWT distance | Up to 72 weeks | The 6-minute walk test (6MWT) measures the distance a participant walks in 6 minutes. Before and after the 6MWT assessment, the participant's blood pressure, heart rate, and SPO2 will be recorded, and the participant's perception of fatigue and dyspnea will be measured. |
| Secondary | Maximum observed serum concentration (Cmax) of ARGX-119 | Up to 42 weeks + 72 weeks | |
| Secondary | Incidence of ADA against ARGX-119 | Up to 42 weeks + 72 weeks | ADA : anti-drug antibodies |
| Secondary | Change from baseline over time for key components of the QMG scale | Up to 42 weeks + 72 weeks | The Quantitative Myasthenia Gravis (QMG) scale is a standardized quantitative scoring system that was developed to assess disease severity based on impairment of body function and structures in patients with MG. Minimum value: 0 (no disease severity); Maximum value: 39 (highest disease severity). The change from active-treatment baseline will be used for the 72 week timepoint. |
| Secondary | Change from baseline over time for MG-ADL | Up to 42 weeks + 72 weeks | The Myasthenia Gravis Activities of Daily Living (MG-ADL) is an 8-item scale that assesses MG symptoms and their effects on daily activities. Minimum value: 0 (normal symptoms); Maximum value: 24 (most severe symptoms). The change from active-treatment baseline will be used for the 72 week timepoint. |
| Secondary | Change from baseline over time for PROMIS-GH scale | Up to 42 weeks | The Patient-Reported Outcomes Measurement Information System Global Health (PROMIS-GH) is a 10-item participant completed quality of life questionnaire that measures global physical health and mental health. The participant records their response to each question on a 5-point Likert scale, with lower scores indicating poorer health (Minimum value: 0, Maximum value: 20) |
| Secondary | Change from active-treatment baseline over time for 6MWT cadence | Up to 72 weeks | The 6-minute walk test (6MWT) measures the distance a participant walks in 6 minutes. Before and after the 6MWT assessment, the participant's blood pressure, heart rate, and SPO2 will be recorded, and the participant's perception of fatigue and dyspnea will be measured. |
| Secondary | Change from active-treatment baseline over time for PROMIS PF-WMA-SF | Up to 72 weeks | The PROMIS PF-WMA-SF is an 11-item, participant-completed questionnaire that assesses lower and upper extremity function and associated activities of daily living. The questionnaire asks the participant to rate the items on a 5-point scale of 5 (without any difficulty) to 0 (unable to do). |
| Secondary | Change from active-treatment baseline over time for Neuro-QoL fatigue | Up to 72 weeks | |
| Secondary | Change from active-treatment baseline over time for FVC | Up to 72 weeks | |
| Secondary | Change from active-treatment baseline over time for PGI-C | Up to 72 weeks | |
| Secondary | Change from active-treatment baseline over time for PGI-S | Up to 72 weeks | |
| Secondary | Change from active-treatment baseline over time for CGI-C | Up to 72 weeks | |
| Secondary | Change from active-treatment baseline over time for CGI-S | Up to 72 weeks | |
| Secondary | Change from active-treatment baseline over time for EQ-5D-5L | Up to 72 weeks | |
| Secondary | Incidence of AEs and SAEs | Up to 72 weeks | AE : Adverse events ; SAE : Serious Adverse events |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT06436742/registered