Trial · NCT04280718
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of treatment-emergent adverse events and serious adverse events | Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study | |
| Secondary | Change from baseline over time of the adjusted INCAT score | Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study | 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 over time of the MRC Sum score | Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study | 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 over time of I-RODS disability scores | Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study | 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 over time of mean grip strength | Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study | |
| Secondary | Change from baseline over time of TUG score | Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study | 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 | Percentage of patients without clinical deterioration over time, defined by adjusted INCAT deterioration ≥1 point compared to baseline. | Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study | 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 | Percentage of patients with titers of binding antibodies towards efgartigimod and the presence of neutralizing antibodies against efgartigimod. | Up to 51 weeks | |
| Secondary | Efgartigimod serum concentrations | Up to 51 weeks | |
| Secondary | Changes from baseline over time of serum IgG levels (total) | Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study | |
| Secondary | Change from baseline over time in EQ-5D-5L | Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study | EQ-5D-5L questionnaire is a patient-reported outcome measure, ranging 0 to 100 (lower score, worse outcome). |
| Secondary | Change from baseline over time in BPI SF | Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study | The Brief Pain Inventory-Short Form (BPI-SF) is a patient-reported outcome measure to assess pain severity and pain interference |
| Secondary | Change from baseline over time in TSQM-9 | Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study | The Treatment Satisfaction Questionnaire for Medication (TSQM) is a 9-item questionnaire to assess treatment satisfaction in naturalistic study designs, in which there is potential that the administration of the side effects domain of the TSQM would interfere with routine clinical care |
| Secondary | Change from baseline over time in RT-FSS | Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study | The Rasch-Transformed Fatigue Severity Scale (RT-FSS) is a 7-item self-reported questionnaire designed to differentiate fatigue from clinical depression. The participant has to rate from 0 to 3 their level of fatigue on 7 items (low score indicates that the statement is not very appropriate, and high score indicates agreement). |
| Secondary | Change from baseline over time in HADS | Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study | The Hospital Anxiety and Depression Scale (HADS) aims to measure symptoms of anxiety and depression in people with physical health problems. HADS is a 14-item scale with 7 items related to anxiety and 7 to depression |
| Secondary | Percentage of patients performing self-administration over time | Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study | |
| Secondary | Percentage of patients with treatment administered by caregiver over time. | Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study |
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/NCT04280718/registered