Trial · NCT03257358
Registered outcomes48
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
41 to 48 of 48
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Secondary | Change From Baseline to Month 12 in Total CD19+ Absolute Cell Count | Baseline to Month 12 | Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected. |
| Secondary | Change From Baseline to Month 12 in Total CD19+ Differential Cell Count (%) | Baseline to Month 12 | Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected. |
| Secondary | Multiple Sclerosis (MS) Relapses During Treatment | Baseline to Month 12 | A relapse is defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (\<37.5°C) or infection. |
| Secondary | Number of Participants Who Received Steroid Treatment for MS Relapses During Treatment | Baseline to Month 12 | A relapse is defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (\<37.5°C) or infection. |
| Secondary | Change From Baseline in Patient Determined Disease Steps (PDDS) | Baseline to Month 12 | PDDS scoring ranges 0 to 8. 0 = Normal; 1 = Mild disability; 2 = Moderate disability; 3 = Gait disability; 4 = Early cane; 5 = Late cane; 6 = Bilateral support; 7 = Wheelchair/scooter; 8 = Bedridden. |
| Secondary | Change From Baseline in T2 Lesion Burden | Baseline to Month 12 | |
| Secondary | Change From Baseline for New Gd-Enhancing T1 Lesion Count | Baseline to Month 12 | |
| Secondary | Change From Baseline to Months 6 and 12 in the Anti-JCV Antibody Index (Index/Value) | Baseline to Month 6 and 12 |
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/NCT03257358/registered?page=3