Trial · NCT05581199
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Period 2, Cohort A: Proportion of participants who remain relapse-free at Week 36 | Week 36 | Relapse is defined as a worsening (increase) of \>=1 point on adjusted inflammatory neuropathy cause and treatment (AdjINCAT) score at any time point during Period 2 relative to Period 2 Baseline which is sustained at a Follow-Up visit 1 week later. The INCAT disability scale is a widely used and validated efficacy assessment of neurologic dysfunction in CIDP. Upper and lower limb dysfunction are each separately assessed on a scale of 0-5 and results are summed together for a total composite score of 0-10. Higher scores represent greater disability. The Adj INCAT disability score is identical to INCAT disability score with exception that changes in upper limb function from 0 (normal) to 1 (minor symptoms) and vice versa are excluded since minor symptoms in the fingers, which are implied by an upper limb score of 1, are not considered clinically significant in all participants. The Adj INCAT disability score will be used for participant selection and measurement of clinical response. |
| Secondary | Period 2, Cohort A: Time to first relapse relative to Period 2 Baseline | Baseline (Week 12) to Week 36 | |
| Secondary | Period 2, Cohort A: Change from Period 2 Baseline in Adj INCAT score | Baseline (Week 12) and up to Week 36 | |
| Secondary | Period 2, Cohort A: Change from Period 2 Baseline in Inflammatory Rasch-built Overall Disability Scale (I-RODS) | Baseline (Week 12) and up to Week 36 | The I-RODS for immune-mediated peripheral neuropathies is a patient-based linearly weighted scale that captures activity and social participation limitations in patients with CIDP. The assessment consists of a 24-question instrument that addresses upper and lower limb tasks that range in difficulty from reading a book and eating to standing and running. Answers are scored on a scale of 0-2 (complete disability to no disability) and the raw scores are then transformed into a final score ranging from 0-100. |
| Secondary | Period 2, Cohort A: Change from Period 2 Baseline in Mean grip strength | Baseline (Week 12) and up to Week 36 | Mean Grip strength provides an objective, quantitative and immediate assessment of strength impairment. The Jamar dynamometer and the Martin vigorimeter are both commonly used to assess mean grip strength. |
| Secondary | Period 2, Cohort A: Change from Period 2 Baseline in Medical Research Council (MRC) Sum Score | Baseline (Week 12) and up to Week 36 | The MRC sum score is a standardized methodology for objectively assessing and reporting muscle function. Six muscle groups are assessed bilaterally, and each scored on a scale of 0 (no visible contraction) to 5 (normal) yielding a sum ranging from 0 (paralysis) to 60 (normal strength). Higher scores indicate normal muscle strength. |
| Secondary | Period 2, Cohort A: Change from Period 2 Baseline in Overall Neuropathy Limitations Scale (ONLS) | Baseline (Week 12) and up to Week 36 | The ONLS is a scale that focuses on upper and lower limb functions and was designed to assess the limitations of participants with immune-mediated peripheral neuropathies. This scale is completed by adding the total of the arm grade from zero point (less limitation) to 5 points (most limitation) and leg grade from zero point (less limitation) to 7 points (more limitation) yielding a total score of 0 (no disability) to 12 (maximum disability). Lower values in the ONLS indicate a better clinical condition. |
| Secondary | Period 2, Cohorts A and B combined: Change from Period 2 Baseline in Adj INCAT score | Baseline (Week 12) and up to Week 36 | |
| Secondary | Period 2, Cohorts A and B combined: Change from Period 2 Baseline in I-RODS | Baseline (Week 12) and up to Week 36 | |
| Secondary | Period 2, Cohorts A and B combined: Change from Period 2 Baseline in Mean Grip Strength | Baseline (Week 12) and up to Week 36 | |
| Secondary | Period 2, Cohorts A and B combined: Change from Period 2 Baseline in MRC sum score | Baseline (Week 12) and up to Week 36 | |
| Secondary | Period 2, Cohorts A and B combined: Change from Period 2 Baseline in ONLS | Baseline (Week 12) and up to Week 36 | |
| Secondary | Period 2, Cohorts A, B, and C: Proportion of participants who remain relapse-free at Week 36 | Week 36 |
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/NCT05581199/registered