Trial · NCT04281472
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 26
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Stage A: Percentage of Participants With Confirmed Evidence of Clinical Improvement(ECI) | Up to 12 weeks during the open-label stage A | |
| 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 | |
| Secondary | Stage A: Time to Initial Confirmed Evidence of Clinical Improvement (ECI) | Up to 12 weeks during the open-label stage A | |
| 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 | Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) scores range from 0-10 with a score of 10 indicating the greatest degree of disability. |
| 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 | The Medical Research Council (MRC) Sum scores range from 0 to 60 with a lower score indicating greater muscle weakness. |
| 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 | The Inflammatory Rasch-built Overall Disability Scale (I-RODS) score ranges from 0-100, with lower scores indicating the greatest degree of disability. |
| 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 | The Timed Up and Go (TUG) score is calculated as the number of seconds needed to complete a series of actions. The longer time needed to complete this test (expressed in seconds) indicates lower mobility. |
| 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 | This is measured with a handheld device called a vigometer |
| 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 | Treatment-emergent (serious) AEs expressed in number of events/100 PYFU (participant years of follow-up) |
| 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)) | |
| 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)) | |
| 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 | |
| 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 | Scores range from 0-100 with 100 indicating the best health state. Therefore, positive changes indicate higher health-related quality of life reported by the patient. |
| Secondary | Stage B: Time to CIDP Disease Progression | Up to 48 weeks during the randomized placebo-controlled stage B | Time to chronic inflammatory demyelinating polyneuropathy (CIDP) disease progression is defined by the time from first dose of double-blind IMP to the first I-RODS score decrease ≥4 points compared to Stage B baseline using the centile metric. |
| 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 | |
| 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 | Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) scores range from 0-10 with a score of 10 indicating the greatest degree of disability. |
| 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 | The Medical Research Council (MRC) Sum scores range from 0 to 60 with a lower score indicating greater muscle weakness. |
| 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 | The Inflammatory Rasch-built Overall Disability Scale (I-RODS) score ranges from 0-100, with lower scores indicating the greatest degree of disability. |
| 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 | The Timed Up and Go (TUG) score is calculated as the number of seconds needed to complete a series of actions. The longer time needed to complete this test (expressed in seconds) indicates lower mobility. |
| 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 | This is measured with a handheld device called a vigometer |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
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/NCT04281472/registered