Trial · NCT06497374
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 | Change in Neurological Disability - Expanded Disability Scale Score | Acute nadir to week4 | The Kurtzke Expanded Disability Status Scale (EDSS) was developed to measure the disability status of subjects with demyelinating disease. It allows an objective quantification of the level of functioning that could be widely and reproducibly used by researchers and health care providers. The EDSS provides a total score on a scale that ranges from 0 to 10 where 0 is normal and 10 is deceased. Increasing disability is reflected in an increasing EDSS score. |
| Secondary | Change of FS score and MRC score at Week 12. | Baseline to week 12. | To evaluate changes in neurologic outcomes in subjects with acute attacks in subjects with AQP4-IgG antibody-positive neuromyelitis optica spectrum disorders who are treated with efgartigimod + IVMP versus IVMP alone at Week 12. The Functional System (FS) was developed to measure the function of seven systems, including visual functions (score 0-6), brainstem functions (score 0-5), pyramical functions (score 0-6), cerebellar functions (score 0-5, X is the condition that pyramidal weakness (BMRC grade 3 or worse in limb strength) or sensory deficits interfere with cerebellar testing), sensory functions (score 0-6), bowel and bladder functions (score 0-6), cerebral functions (score 0-5). Increasing disability of different functional system is reflected in an increasing FS score. Muscle Power Assessment (MRC) was developed to assess the muscle power of limbs. A score of 0-5 was used to grade the power. Increasing disability of muscle power is reflected in an decreasing MRC score. |
| Secondary | Change of EDSS score, FS score, and MRC score at Week 4 and 24. | Baseline to Week 4 and Week 24. | To evaluate changes in neurologic outcomes in subjects with acute attacks in subjects with AQP4-IgG antibody-positive neuromyelitis optica spectrum disorders who are treated with efgartigimod + IVMP versus IVMP alone at Week 4 and Week 24. The EDSS score, FS score MRC score was described as in outcome 2. |
| Secondary | Change of EQ-5D-5L score. | Baseline to Week 4, 12 and 24. | To evaluate changes in quality of life in subjects at Week 4, 12, 24. |
| Secondary | Change of high-contrast visual acuity in subjects with acute optic neuritis. | Baseline to Week 4, 12 and 24. | To evaluate changes in vision outcomes (High contrast visual acuity ) in subjects with acute optic neuritis post-treatment at Week 4, 12, 24. |
| Secondary | Change of OCT measurements in subjects with acute optic neuritis. | Baseline to Week 4, 12 and 24. | To evaluate changes in vision outcomes (OCT measures) in subjects with acute optic neuritis post-treatment at Week 4, 12, 24. |
| Secondary | The proportion of participants requiring rescue treatment during the study period. | Baseline to Week 24. | To evaluate the proportion of subjects requiring rescue treatment during the study period. |
| Secondary | The incidence of adverse events in the subjects during the study period. | Baseline to Week 24. | To evaluate the safety and tolerability of efgartigimod +IVMP versus IVMP alone. |
| Secondary | The vital signs, clinical laboratory indices, and electrocardiogram records of the subjects during the study period. | Baseline to Week 24. | To evaluate the vital signs, clinical laboratory parameters and electrocardiograms during the study. |
| Other | Change of serum total IgG levels. | Baseline to Week 4, 12 and 24. | To evaluate changes in serum levels of total IgG in participants post-treatment at Week 4, 12, 24. |
| Other | Change of serum AQP4-IgG antibody levels. | Baseline to Week 4, 12 and 24. | To evaluate changes in serum levels of AQP4-IgG antibodies in participants post-treatment at Week 4, 12, 24. |
| Other | Change of serum GFAP and NfL. | Baseline to Week 4, 12 and 24. | To evaluate changes in serum GFAP and NfL levels in participants after treatment at Week 4, 12 and 24. |
| Other | Change of the size and extent of MRI lesions. | Baseline to Week 4, 12 and 24. | To evaluate changes in spinal cord imaging in participants with acute myelitis following a course of efgartigimod + IVMP versus IVMP alone at Week 4, 12 and 24. |
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.
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