Trial · NCT07899502
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | No Evidence of Disease Activity (NEDA-3) | From treatment baseline through study completion, up to 24 years | Composite time-to-event outcome. NEDA-3 failure is the first occurrence of a clinical relapse, MRI activity, or 6-month confirmed disability progression. Clinical relapse is new or worsening MS-related neurological symptoms lasting at least 24 hours, without fever, infection, or another explanation. MRI activity is new or enlarging T2 lesions and/or gadolinium-enhancing T1 lesions. Confirmed disability progression is assessed using the Expanded Disability Status Scale and confirmed after 6 months. |
| Secondary | Absence of clinical relapses | From treatment baseline through study completion, up to 24 years | Proportion of participants with no clinical relapse during follow-up. A clinical relapse is new or worsening neurological symptoms attributable to MS, lasting at least 24 hours, occurring without fever, infection, or another alternative explanation, and separated from a previous relapse by at least 30 days. |
| Secondary | Annualised relapse rate | From treatment baseline through study completion, up to 24 years | Number of clinical relapses per participant-year of follow-up. |
| Secondary | Absence of MRI activity | From treatment baseline through study completion, up to 24 years | Proportion of participants with no MRI activity during follow-up. MRI activity is defined as new or enlarging T2 lesions and/or gadolinium-enhancing T1 lesions on follow-up MRI compared with the reference scan. |
| Secondary | Absence of 6-month confirmed disability progression (CDP) | From treatment baseline through study completion, up to 24 years | Proportion of participants without 6-month CDP, assessed using the Expanded Disability Status Scale (EDSS). Confirmed disability progression is an increase in EDSS of 1.0 point when baseline EDSS is below 6.0, or 0.5 point when baseline EDSS is 6.0 or higher, confirmed 6 months after the reported change. |
| Secondary | Absence of progression independent of relapse activity (PIRA) | From treatment baseline through study completion, up to 24 years | Proportion of participants without PIRA. PIRA is defined as confirmed disability progression occurring without a relapse during the 90 days before and 30 days after the event, including the 90 days before and 30 days after confirmation. |
| Secondary | Probability of 6-month confirmed disability improvement (CDI) | From treatment baseline through study completion, up to 24 years | Proportion of participants with 6-month CDI, defined as a decrease in EDSS of 1.0 point when baseline EDSS is below 6.0, or 0.5 point when baseline EDSS is 6.0 or higher, confirmed 6 months after the reported change. |
| Secondary | Time to first clinical relapse | From treatment baseline through study completion, up to 24 years | Time from treatment baseline to the first clinical relapse. |
| Secondary | Time to first MRI activity | From treatment baseline through study completion, up to 24 years | Time from treatment baseline to the first MRI showing new or enlarging T2 lesions and/or gadolinium-enhancing T1 lesions compared with the reference scan. |
| Secondary | Time to 6-month confirmed disability progression | From treatment baseline through study completion, up to 24 years | Time from treatment baseline to the first occurrence of 6-month confirmed disability progression, assessed using EDSS criteria. |
| Secondary | Time to progression independent of relapse activity | From treatment baseline through study completion, up to 24 years | Time from treatment baseline to the first occurrence of PIRA, defined as confirmed disability progression not temporally associated with a clinical relapse. |
| Secondary | Time to treatment discontinuation or switch | From treatment baseline through study completion, up to 24 years | Time from treatment baseline to discontinuation of the initial treatment or switch to another MS disease-modifying therapy. |
| Secondary | Serious adverse events | From treatment baseline through study completion, up to 24 years | Number and proportion of participants with serious adverse events recorded in routine clinical data. A serious adverse event is an event that results in death, is life-threatening, requires or prolongs hospitalisation, results in significant disability or incapacity, is a congenital anomaly or birth defect, or is otherwise considered medically important. |
| Secondary | Mortality | From treatment baseline through study completion, up to 24 years | Number and proportion of participants who die during follow-up; cause of death and whether the death was considered treatment-related will be recorded where available. |
| Other | Infections and viral reactivations | From treatment baseline through study completion, up to 24 years | Number and proportion of participants with clinically recorded infections or viral reactivations, including JC virus seroconversion in natalizumab-treated participants and Epstein-Barr virus or cytomegalovirus reactivation after AHSCT, where available in routine clinical data. |
| Other | Hospitalisations | From treatment baseline through study completion, up to 24 years | Number and proportion of participants with hospitalisations recorded in routine clinical data. |
| Other | Malignancies and secondary autoimmune diseases | From treatment baseline through study completion, up to 24 years | Number and proportion of participants with malignancies or secondary autoimmune diseases recorded during follow-up. |
| Other | Changes in routine laboratory parameters | From treatment baseline through study completion, up to 24 years | Change from baseline in routinely collected laboratory parameters, including white blood cell count and immunoglobulin levels, where available. |
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
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GET https://conductscience.org/api/trials/v1/NCT07899502/registered