Trial · NCT04281472
Outcomes26
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 26
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Stage A: Percentage of Participants With Confirmed Evidence of Clinical Improvement(ECI) | Up to 12 weeks during the open-label stage A | SAF-A (Stage A safety analysis set): Participants who received at least 1 dose or part of a dose of efgartigimod PH20 SC in Stage A | percentage of participants | NUMBER |
| PRIMARY | Stage B: Time to First Adjusted INCAT Deterioration Compared to Stage B Baseline | Up to 48 weeks during the randomized placebo-controlled stage B | mITT (modified intent-to-treat) analysis set; Participants who were randomized in Stage B and who received at least 1 dose or part of a dose of IMP in Stage B. | Days | MEDIAN |
| SECONDARY | Stage A: Time to Initial Confirmed Evidence of Clinical Improvement (ECI) | Up to 12 weeks during the open-label stage A | SAF-A (Stage A safety analysis set): Participants who received at least 1 dose or part of a dose of efgartigimod PH20 SC in Stage A | days | NUMBER |
| SECONDARY | Stage A: Change From Stage A Baseline to Last Assessment in Stage A, in Adjusted INCAT Score | Up to 12 weeks during the open-label stage A | SAF-A (Stage A safety analysis set): Participants who received at least 1 dose or part of a dose of efgartigimod PH20 SC in Stage A | score on a scale | MEAN |
| SECONDARY | Stage A: Change From Stage A Baseline to Last Assessment in Stage A, in Medical Research Council (MRC) Sum Score | Up to 12 weeks during the open-label stage A | SAF-A (Stage A safety analysis set): Participants who received at least 1 dose or part of a dose of efgartigimod PH20 SC in Stage A | score on a scale | MEAN |
| SECONDARY | Stage A: Change From Stage A Baseline to Last Assessment in Stage A, in I-RODS Disability Scores | Up to 12 weeks during the open-label stage A | SAF-A (Stage A safety analysis set): Participants who received at least 1 dose or part of a dose of efgartigimod PH20 SC in Stage A | score on a scale | MEAN |
| SECONDARY | Stage A: Change From Stage A Baseline to Last Assessment in Stage A, in TUG Score | Up to 12 weeks during the open-label stage A | SAF-A (Stage A safety analysis set): Participants who received at least 1 dose or part of a dose of efgartigimod PH20 SC in Stage A | seconds | MEAN |
| SECONDARY | Stage A: Change From Stage A Baseline to Last Assessment in Stage A, in Mean Grip Strength | Up to 12 weeks during the open-label stage A | SAF-A (Stage A safety analysis set): Participants who received at least 1 dose or part of a dose of efgartigimod PH20 SC in Stage A | Kilopascal (kPa) | MEAN |
| SECONDARY | Stage A: Exposure Adjusted Occurrence of Treatment-emergent Adverse Events and Serious Adverse Events | Up to 12 weeks during the open-label stage A | SAF-A (Stage A safety analysis set): Participants who received at least 1 dose or part of a dose of efgartigimod PH20 SC in Stage A | Events/100 PYFU | NUMBER |
| SECONDARY | Stage A: Pre-dosing Efgartigimod Serum Concentrations Over Time | Up to 13 weeks during the open-label stage A (12 weeks + optional 1 additional week to confirm evidence of clinical improvement (ECI)) | The number analyzed in rows decreases due to participants withdrawing from the study and missing participant data. Week 13 was an optional additional week for the confirmation of the ECI. PK-A (Stage A PK analysis set): Participants from the SAF-A for whom at least 1 serum PK concentration during Stage A is available | ug/mL | MEAN |
| SECONDARY | Stage A: Percent Changes From Stage A Baseline of Serum IgG Levels Over Time | Up to 13 weeks during the open-label stage A (12 weeks + optional 1 additional week to confirm evidence of clinical improvement (ECI)) | The number analyzed in rows decreases due to participants advancing to stage B or withdrawing from the study and missing patient data. Week 13 was an optional additional week for the confirmation of the evidence of clinical improvement (ECI). PD-A (Stage A PD analysis set): Participants from the SAF-A for whom at least 1 serum PD concentration during Stage A is available. | percent change | MEAN |
| SECONDARY | Stage A: Number of Participants With Binding Antidrug Antibodies (ADA) Towards Efgartigimod or Antibodies (Ab) Against rHuPH20 and Neutralizing Antibodies (NAb) Against Efgartigimod and/or rHuPH20 | Up to 12 weeks during the open-label stage A | The number of participants analyzed is different since it is based on the number of evaluable participants for each drug. For Ab and NAb against rHuPH20 only 316 participants were evaluable, whereas for ADA and NAb towards efgartigimod 317 participants were evaluable. IMM-A (Stage A immunogenicity analysis set): Participants from the SAF-A for whom at least 1 ADA sample during Stage A is available | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Stage A: Changes From Stage A Baseline to Last Assessment in Stage A, in EQ-5D-5L Visual Analog Scale (VAS) Over Time | Up to 12 weeks during the open-label stage A | SAF-A (Stage A safety analysis set): Participants who received at least 1 dose or part of a dose of efgartigimod PH20 SC in Stage A | score on a scale | MEAN |
| SECONDARY | Stage B: Time to CIDP Disease Progression | Up to 48 weeks during the randomized placebo-controlled stage B | mITT (modified intent-to-treat) analysis set; Participants who were randomized in Stage B and who received at least 1 dose or part of a dose of IMP in Stage B. | days | MEDIAN |
| SECONDARY | Stage B: Number of Participants With Improved Functional Level Compared to Stage B Baseline | Up to 48 weeks during the randomized placebo-controlled stage B | mITT (modified intent-to-treat) analysis set; Participants who were randomized in Stage B and who received at least 1 dose or part of a dose of IMP in Stage B. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Stage B: Change From Stage B Baseline to Last Assessment in Stage B, in Adjusted INCAT Score | Up to 48 weeks during the randomized placebo-controlled stage B | mITT (modified intent-to-treat) analysis set; Participants who were randomized in Stage B and who received at least 1 dose or part of a dose of IMP in Stage B. | score on a scale | MEAN |
| SECONDARY | Stage B: Change From Stage B Baseline to Last Assessment in Stage B, in MRC Sum Score | Up to 48 weeks during the randomized placebo-controlled stage B | mITT (modified intent-to-treat) analysis set; Participants who were randomized in Stage B and who received at least 1 dose or part of a dose of IMP in Stage B. | score on a scale | MEAN |
| SECONDARY | Stage B: Change From Stage B Baseline to Last Assessment in Stage B, in 24-item I-RODS Disability Score | Up to 48 weeks during the randomized placebo-controlled stage B | mITT (modified intent-to-treat) analysis set; Participants who were randomized in Stage B and who received at least 1 dose or part of a dose of IMP in Stage B. | score on a scale | MEAN |
| SECONDARY | Stage B: Change From Stage B Baseline to Last Assessment in Stage B, in TUG Score | Up to 48 weeks during the randomized placebo-controlled stage B | mITT (modified intent-to-treat) analysis set; Participants who were randomized in Stage B and who received at least 1 dose or part of a dose of IMP in Stage B. | seconds | MEAN |
| SECONDARY | Stage B: Change From Stage B Baseline to Last Assessment in Stage B, in Mean Grip Strength | Up to 48 weeks during the randomized placebo-controlled stage B | Kilopascal (kPa) | MEAN |
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/NCT04281472/outcomes