Trial · NCT02861014
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 27
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With No Evidence of Disease Activity (NEDA) as Per Protocol Defined Events During a 96-Week Period | Week 96 | A protocol-defined event of disease activity was defined by the occurrence of at least one of the following while on treatment with ocrelizumab: * A protocol-defined relapse (PDR) * 24-week CDP based on increase in EDSS while on treatment with ocrelizumab * A T1 Gd-enhanced lesion after Week 8 * A new and/or enlarging T2 hyperintense lesion on MRI after Week 8 compared to the Week 8 MRI scan |
| Secondary | Percentage of Participants Free From a Protocol-Defined Event of Disease Activity During 24 Weeks Period | Baseline up to 24 weeks | A protocol-defined event of disease activity was defined by the occurrence of at least one of the following while on treatment with ocrelizumab: * A protocol-defined relapse (PDR) * 24-week CDP based on increase in EDSS while on treatment with ocrelizumab * A T1 Gd-enhanced lesion after Week 8 * A new and/or enlarging T2 hyperintense lesion on MRI after Week 8 compared to the Week 8 MRI scan |
| Secondary | Percentage of Participants Free From a Protocol-Defined Event of Disease Activity During 48 Weeks Period | Baseline up to 48 weeks | A protocol-defined event of disease activity was defined by the occurrence of at least one of the following while on treatment with ocrelizumab: * A protocol-defined relapse (PDR) * 24-week CDP based on increase in EDSS while on treatment with ocrelizumab * A T1 Gd-enhanced lesion after Week 8 * A new and/or enlarging T2 hyperintense lesion on MRI after Week 8 compared to the Week 8 MRI scan |
| Secondary | Time to First Protocol-Defined Event of Disease Activity | Baseline up to 96 Weeks | The definition of a protocol-defined event of disease activity is the occurrence of at least one of the following while on treatment with ocrelizumab: * A protocol-defined relapse defined as: Symptoms must persist for \>24 hours and should not be attributable to confounding clinical factors; Symptoms should be preceded by neurological stability for at least 30 days; Symptoms should be accompanied by new objective neurological worsening determined with a timely EDSS/ Functional Systems Score (FSS) assessment * 24 weeks confirmed disability progression based on increases in EDSS while on treatment with ocrelizumab * A T1 Gd-enhanced lesion after Week 8 * A new and/or enlarging T2 hyperintense lesion on MRI after Week 8 compared to the Week 8 MRI scan. |
| Secondary | Change From Baseline to Week 96 in Expanded Disability Status Scale (EDSS) | Baseline, Weeks: 24, 48, 72, 96 | The EDSS is an ordinal clinical rating scale ranging from 0 (normal neurologic examination) to 10 (death due to MS) in half-point increments. |
| Secondary | Absolute Change From Baseline in EDSS Category at Week 96 | Up to Week 96 | The EDSS is an ordinal clinical rating scale ranging from 0 (normal neurologic examination) to 10 (death due to MS) in half-point increments. |
| Secondary | Percentage of Participants With a Baseline EDSS Score ≥2 With CDI at Week 96 | Week 96 | The EDSS is an ordinal clinical rating scale ranging from 0 (normal neurologic examination) to 10 (death due to MS) in half-point increments. |
| Secondary | Annualized Protocol-defined Relapse Rate at Week 96 | Week 96 | |
| Secondary | Time to Onset of 24-week Confirmed Disability Progression | Baseline up to 96 Weeks | |
| Secondary | Time to Onset of First Protocol-Defined Relapse | Baseline up to 96 Weeks | A protocol-defined multiple sclerosis (MS) relapse is an occurrence of new or worsening neurological symptoms attributable to MS that meets the following criteria: * Symptoms must persist for \>24 hours and should not be attributable to confounding clinical factors (e.g., fever, infection, injury, adverse reactions to medications) * Symptoms should be preceded by neurological stability for at least 30 days * Symptoms should be accompanied by new objective neurological worsening determined with a timely EDSS/ Functional Systems Score (FSS) assessment, consistent with an increase of at least: * ≥ 0.5 points on EDSS scale * or ≥ 2 points on one of the following FSS scales: pyramidal, ambulation, cerebellar, brainstem, sensory, or visual * or ≥ 1 point on two or more of the following FSS scales: pyramidal, ambulation, cerebellar, brainstem, sensory, or visual |
| Secondary | Time to Onset of First New and/or Enlarging T2 Lesion | Baseline up to 96 Weeks | |
| Secondary | Mean Number of T1 Gd-enhancing Lesions Per MRI Scan at Weeks 24, 48 and 96 | Weeks: 24, 48, 96 | Mean number of T1 Gd-enhancing lesions per MRI scan: Total number of T1 Gd-enhanced lesions divided by the total number of interpretable MRI scans |
| Secondary | Change From Baseline to Week 96 in Total T2 Lesion Volume Detected by Brain MRI From | Baseline, Week 96 | |
| Secondary | Percentage Change From Baseline to Week 96 in Total T2 Lesion Volume Detected by Brain MRI | Baseline, Week 96 | |
| Secondary | Volume of New and/or Enlarging T2 Hyperintense Lesions Volume of Lesions Per MRI Scan at Weeks 24, 48, 96 | Weeks 24, 48, 96 | The number of new and/or enlarging T2 lesions at week 24, 48 and 96 is calculated as the sum of the individual number of new and/or enlarging lesions at each visit. Data from other unscheduled assessments is included in this summary or analysis. |
| Secondary | Mean Number of New and/or Enlarging T2 Hyperintense Lesions Per MRI Scan | Weeks 24, 48, 96 | Mean number of new and/or enlarging T2 hyperintense lesions per MRI scan: Total number of new and/or enlarging T2 hyperintense lesions divided by the total number of interpretable MRI scans |
| Secondary | Change From Baseline at Week 48 and 96 in T1 Hypointense Lesion Volume | Weeks 48, 96 | |
| Secondary | Percentage Change From Baseline at Week 48 and 96 in T1 Hypointense Lesion Volume | Weeks 48, 96 | |
| Secondary | Adjusted Mean Change From Baseline at Week 48 and 96 in T1 Hypointense Lesion Volume | Weeks 48, 96 | |
| Secondary | Adjusted Mean Percentage Change From Baseline in Brain Volume | Weeks 24, 48, 96 |
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.
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GET https://conductscience.org/api/trials/v1/NCT02861014/registered