Trial · NCT05327114
Registered outcomes30
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 30
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Stage B: Time to First Occurrence of a Relapse Event | Up to 52 weeks | Stage B time to first occurrence of a relapse event will be reported. |
| Secondary | Stage A: Time to Initial Confirmed Evidence of Clinical Improvement (ECI) | 12 weeks | Time to initial confirmed ECI will be reported. |
| Secondary | Stage A: Percentage of Responders as Determined by ECI | 12 weeks | Stage A percentage of responders as determined by ECI will be reported. |
| Secondary | Stage A: Change from Baseline Over Time in Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Scale Score | Baseline to 12 weeks | Change from Stage A baseline over time in adjusted INCAT disability scale score will be reported. The INCAT disability scale is a clinician-rated assessment that measures activity limitation and degree of functional disability. The INCAT scale is an ordinal scale scored from 0 to 10, with higher scores indicating more disability. |
| Secondary | Stage A: Change from Stage A Baseline Over Time in Medical Research Council (MRC) Muscle Grading Scale Sum Score | Baseline to 12 weeks | Change from Stage A baseline over time in MRC muscle grading scale sum score will be reported. The MRC muscle grading scale is a clinician-rated outcome that provides a strength rating (on a scale from 0 \[no visible contraction\] to 5 \[normal\]) in 6 muscles collected bilaterally: deltoid, biceps, wrist extensors, iliopsoas, quadriceps, tibialis anterior. Lower scores indicate greater impairment. |
| Secondary | Stage A: Change from Baseline Over Time in Inflammatory Rasch-Built Overall Disability Scale (I-RODS) Centile Score | Baseline to 12 weeks | Change from Stage A baseline over time in I-RODS centile score will be reported. The I-RODS comprises of 24 items representing common daily activities that address upper and lower limb disability and range in difficulty from very easy to very difficult. Lower scores indicate greater activity and social participation limitations. |
| Secondary | Stage A: Change from Baseline Over Time in Mean Grip Strength (Dominant Hand) | Baseline to 12 weeks | Change from Stage A baseline over time in mean grip strength (dominant hand) will be reported. Grip Strength is a quantifiable, objective performance outcome measure of hand strength, which can be measured using various devices (for example, Martin Vigorimeter and Jamar Dynamometer). |
| Secondary | Stage A: Change from Baseline Over Time in Mean Grip Strength (Non-Dominant Hand) | Baseline to 12 weeks | Change from Stage A baseline over time in mean grip strength (non-dominant hand) will be reported. Grip Strength is a quantifiable, objective performance outcome measure of hand strength, which can be measured using various devices (for example, Martin Vigorimeter and Jamar Dynamometer). |
| Secondary | Stage B: Time to First Adjusted INCAT Disability Scale Score Deterioration Relative to Baseline | Up to 52 weeks | Time to first adjusted INCAT disability scale score deterioration relative to Stage B baseline will be reported. |
| Secondary | Stage B: Time to First Switch to Intravenous Immunoglobulin (IVIg) or Other Standard of Care (SoC) as a Result of Investigator-assessed Lack of Efficacy as Confirmed by an Independent RAC Relative to Baseline | Up to 52 weeks | Time to first switch to IVIg or other SoC as a result of investigator-assessed lack of efficacy as confirmed by an independent Relapse Adjudication Committee (RAC) relative to Stage B baseline will be reported. |
| Secondary | Stage B: Change from Baseline Over Time in Adjusted INCAT Disability Score | Up to 52 weeks | Change from Stage B baseline over time in adjusted INCAT disability score will be reported. |
| Secondary | Stage B: Change from Baseline Over Time in MRC Muscle Grading Scale Sum Score | Up to 52 weeks | Change from Stage B baseline over time in MRC Muscle Grading Scale Sum score will be reported. |
| Secondary | Stage B: Change from Baseline Over Time in I-RODS Centile Score | Up to 52 weeks | Change from Stage B baseline over time in I-RODS centile score will be reported. |
| Secondary | Stage B: Change from Baseline Over Time in Mean Grip Strength (Dominant Hand) | Up to 52 weeks | Change from Stage B baseline over time in mean grip strength (dominant hand) will be reported. Grip Strength is a quantifiable, objective performance outcome measure of hand strength, which can be measured using various devices (for example, Martin Vigorimeter and Jamar Dynamometer). |
| Secondary | Stage B: Change from Baseline Over Time in Mean Grip Strength (Non-Dominant Hand) | Up to 52 weeks | Change from Stage B baseline over time in mean grip strength (non-dominant hand) will be reported. Grip Strength is a quantifiable, objective performance outcome measure of hand strength, which can be measured using various devices (for example, Martin Vigorimeter and Jamar Dynamometer). |
| Secondary | Stage B: Number of Participants with Binary Response Endpoint Satisfying all 4 Conditions: a) An Improved Adjusted INCAT Disability Score Compared to Baseline; b) Not Relapsing; c) Not Switching to SoC; d) Not Discontinuing Treatment | Up to 52 weeks | Number of participants with Binary response endpoint satisfying all 4 conditions: a) an improved adjusted INCAT Disability Score compared to Stage B baseline; b) not relapsing; c) not switching to SoC; d) not discontinuing treatment, will be reported. |
| Secondary | Percentage of Participants with Treatment-emergent Adverse Events (TEAEs) | Stage A: 12 weeks; Stage B: Up to 52 weeks | An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment |
| Secondary | Percentage of Participants with Serious Adverse Events (SAEs) | Stage A: 12 weeks; Stage B: Up to 52 weeks | SAE is an adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important. |
| Secondary | Number of Participants with Change in Electrocardiogram (ECG) Values Over Time | Stage A: 12 weeks; Stage B: Up to 52 weeks | Number of participants with change in ECG values over time will be reported. |
| Secondary | Number of Participants with Change in Vital Signs Values Over Time | Stage A: 12 weeks; Stage B: Up to 52 weeks | Number of participants with change in vital signs values over time will be reported. |
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/NCT05327114/registered