Trial · NCT05817669
Outcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Meeting Overall CRESS Response of at Least 3 of 5 Items at Week 24 | Week 24 | The Efficacy Analysis Set (EAS) included all participants eligible for efficacy evaluation. | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With TEAEs, AESI, and SAEs | Up to 32 weeks | The Safety Analysis Set (SAF) included all participants exposed to the study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With MCII in ESSDAI at Week 24 | Week 24 | EAS. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Low Disease Activity in ESSDAI at Week 24 | Week 24 | EAS. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With MCII in clinESSDAI at Week 24 | Week 24 | EAS. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Low Disease Activity in clinESSDAI at Week 24 | Week 24 | EAS. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With MCII in ESSPRI at Week 24 | Week 24 | EAS. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in ESSDAI Score at Week 24 | Baseline (Day 1) and Week 24 | EAS - Only participants with data collected at baseline and Week 24 are reported. | score on a scale | MEDIAN |
| SECONDARY | Change From Baseline in clinESSDAI Score at Week 24 | Baseline (Day 1) and Week 24 | EAS - Only participants with data collected at baseline and Week 24 are reported. | score on a scale | MEDIAN |
| SECONDARY | Change From Baseline in ESSPRI Score at Week 24 | Baseline (Day 1) and Week 24 | EAS - Only participants with data collected at Baseline and Week 24 are reported. | score on a scale | MEDIAN |
| SECONDARY | Percentage of Participants With STAR Score of at Least 5 at Week 24 | Week 24 | EAS. | Percentage of participants | NUMBER |
| SECONDARY | Plasma Concentration of Efgartigimod | Pre-dose at Day 1, Weeks 1, 2, 4, 8, 12, 16, and 20; 30 minutes post-dose at Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24 | PK population included all randomized participants who received at least 1 dose of efgartigimod and had at least 1 measured concentration of efgartigimod at a scheduled PK time point. Only participants with data collected at specified timepoints are reported. | Nanograms per milliliter (ng/mL) | MEAN |
| SECONDARY | Percentage Change From Baseline in Total IgG Levels in Serum at Week 24 | Baseline (Day 1) and Week 24 | SAF - Only participants with data available at baseline and Week 24 are reported. | Percentage change | MEAN |
| SECONDARY | Number of Participants With ADA Against Efgartigimod in Serum | Up to Week 24 | SAF. | Participants | COUNT_OF_PARTICIPANTS |
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/NCT05817669/outcomes