Trial · NCT05242133
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Annualized Relapse Rate | 96 weeks | The total number of relapses divided by the total person-time at risk of relapse. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. |
| Secondary | Proportion of patients with 12 weeks of sustained disability progression | Baseline up to week 96 | Clinical evaluation |
| Secondary | Total number of new or newly enlarging T2-hyperintense lesions as detected by brain MRI | Baseline up to week 96 | Sum of the individual number of new or newly enlarging T2-hyperintense lesions at weeks 24, 48, and 96 |
| Secondary | Total number of gadolinium enhancing lesions as detected by brain MRI | Baseline up to week 96 | Sum of the individual number of gadolinium enhancing lesions at weeks 24, 48, and 96 |
| Secondary | Total number of new or newly enlarging T1 hypointense lesions as detected by brain MRI | Baseline up to week 96 | Sum of the individual number new T1 hypointense lesions at weeks 24, 48, and 96 |
| Secondary | Total number of new active lesions as detected by brain MRI | Baseline up to week 96 | Sum of gadolinium enhancing plus non-enhancing new or newly enlarging T2 hyperintense lesions |
| Secondary | Volume of new or newly enlarging T2 hyperintense lesions as detected by brain MRI | Baseline up to week 96 | Inflammatory activity based on MRI measurement of new or newly enlarging T2 lesion volume |
| Secondary | Volume of gadolinium enhancing lesions as detected by brain MRI | Baseline up to week 96 | Inflammatory activity based on MRI measurement of gadolinium enhancing T1 lesion volume |
| Secondary | Volume of new or newly enlarging T1 hypointense lesions as detected by brain MRI | Baseline up to week 96 | Inflammatory activity based on MRI measurement of hypointense T1 lesion volume |
| Secondary | Brain atrophy | Baseline up to week 96 | Percentage of brain volume change from baseline detected by brain MRI |
| Other | Number of participants with Adverse Events (AEs) | 96 weeks | Intensity, seriousness and causality assessment of observed AEs, and abnormal laboratory findings |
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT05242133/registered