Trial · NCT06920004
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 | Reduction of ≥1 point compared with baseline in aINCAT score at week 24 | up to 24 weeks | The Adjusted Inflammatory Neuropathy Cause and Treatment Disability Score (aINCAT) score is a 10-point scale that covers the functionality of legs and arms. The score varies between 0 and 10 (higher score, worse outcome). |
| Secondary | Change from baseline in I-RODS centile points score at week 24 | up to 24 weeks | Inflammatory Rasch-built Overall Disability Scale (I-RODS) assesses the limitations of activities and social participation in patients with inflammatory neuropathies like CIDP. The score ranges from 0 to 100 (higher score, worse outcome). |
| Secondary | Change from baseline in MRC-SS at week 24 | up to 24 weeks | The Medical Research Council Sum Score evaluates motor strength. Evaluated on 6 muscle groups on each side, the score varies from 0 to 60 (lower score, worse outcome). |
| Secondary | Change from baseline in grip strength (3-day moving average) in the dominant hand at week 24 | up to 24 weeks | The grip strength will be measured daily by using a Martin-Vigorimeter. The 3 daily measurements of grip strength from the left hand and the 3 daily measurements of grip strength from the right hand will be recorded, and the daily average for the left hand and right hand will be calculated, respectively. The 3-day moving average will be generated based on the average of the obtained averages for each hand on the target day and the preceding 2 days. |
| Secondary | Time to reduction of ≥1 point from baseline in aINCAT score | up to 24 weeks | The Adjusted Inflammatory Neuropathy Cause and Treatment Disability Score (aINCAT) score is a 10-point scale that covers the functionality of legs and arms. The score varies between 0 and 10 (higher score, worse outcome). |
| Secondary | Change from baseline in TUG at week 24 | up to 24 weeks | The Timed Up and Go Test (TUG) is a simple test to assess a person's mobility in which the time expended to rise from a chair, walk 3 meters, turn around, walk back to the chair, and sit down is measured. |
| Secondary | Time to increase of ≥1 point compared with baseline in aINCAT score | Up to 24 weeks | The Adjusted Inflammatory Neuropathy Cause and Treatment Disability Score (aINCAT) score is a 10-point scale that covers the functionality of legs and arms. The score varies between 0 and 10 (higher score, worse outcome). |
| Secondary | Change from baseline in grip strength (3-day moving average) of both hands over time | up to 24 weeks + 96 weeks (Part B) | The grip strength will be measured daily by using a Martin-Vigorimeter. The 3 daily measurements of grip strength from the left hand and the 3 daily measurements of grip strength from the right hand will be recorded, and the daily average for the left hand and right hand will be calculated, respectively. The 3-day moving average will be generated based on the average of the obtained averages for each hand on the target day and the preceding 2 days. |
| Secondary | Change from baseline in grip strength (daily average) for both hands | up to 24 weeks + 96 weeks (Part B) | The grip strength will be measured daily by using a Martin-Vigorimeter. The 3 daily measurements of grip strength from the left hand and the 3 daily measurements of grip strength from the right hand will be recorded, and the daily average for the left hand and right hand will be calculated, respectively. A daily average will be generated based on the average of the obtained averages for each hand. |
| Secondary | Change from baseline in MRC-SS over time | up to 96 weeks (Part B) | The Medical Research Council Sum Score evaluates motor strength. Evaluated on 6 muscle groups on each side, the score varies from 0 to 60 (lower score, worse outcome). |
| Secondary | Change from baseline in aINCAT over time | up to 24 weeks (Part A) + 96 weeks (Part B) | The Adjusted Inflammatory Neuropathy Cause and Treatment Disability Score (aINCAT) score is a 10-point scale that covers the functionality of legs and arms. The score varies between 0 and 10 (higher score, worse outcome). |
| Secondary | Change from baseline in EQ-5D-5L over time | up to 24 weeks (Part A) + 96 weeks (Part B) | EQ-5D-5L questionnaire is a patient-reported outcome measure, ranging 0 to 100 (lower score, worse outcome). |
| Secondary | Change from baseline in RT-FSS over time | up to 24 weeks (Part A) + 96 weeks (Part B) | Rasch-Transformed Fatigue Severity Scale (RT-FSS) is a patient-reported outcome measure to distinguish fatigue from clinical depression. |
| Secondary | Change from baseline in SF-12 over time | up to 24 weeks (Part A) + 96 weeks (Part B) | 12-Item Short Form Health Survey (SF-12) is a general patient-reported outcome measure. |
| Secondary | Change from baseline in BPI-SF over time | up to 24 weeks (Part A) + 96 weeks (Part B) | The Brief Pain Inventory-Short Form (BPI-SF) is a patient-reported outcome measure to assess pain severity and pain interference. |
| Secondary | PGI-S values over time | up to 24 weeks (Part A) + 96 weeks (Part B) | The Patient Global Impression of Severity (PGI-S) is a patient-reported outcome measure that reflects the patient's belief about the severity of the illness. |
| Secondary | PGI-C values over time | up to 24 weeks (Part A) + 96 weeks (Part B) | The Patient Global Impression of Change (PGI-C) is a patient- reported outcome measure that reflects the patient's belief about the efficacy of treatment. |
| Secondary | Values for work-related and household chore activities of the HRPQ | up to 24 weeks | The Health-Related Productivity Questionnaire (HRPQ) assesses health-related and work-related productivity, with questions related to 'hours lost because of absenteeism'. |
| Secondary | Percentage of scheduled hours lost in total (absenteeism+ presenteeism) | up to 24 weeks | |
| Secondary | Change from baseline in I-RODS centile points score over time | Up to 96 weeks (Part B) | Inflammatory Rasch-built Overall Disability Scale (I-RODS) assesses the limitations of activities and social participation in patients with inflammatory neuropathies like CIDP. The score ranges from 0 to 100 (higher score, worse outcome). |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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/NCT06920004/registered