Trial · NCT01514370
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects With Active (New or Enlarging) T2 Lesions Assessed by Magnetic Resonance Imaging (MRI) at Month 12 | Month 12 | A single T2 lesion was defined as an area of increased signal on a given 3-millimeters axial image that was not referable to normally hyperintense structures. New T2 lesions were those that appear in areas where on the previous scan no abnormality was detected. All T2 lesions were detected by an MRI scan. |
| Secondary | Percentage of Relapse-Free Subjects at Month 12 and Month 24 | Month 12 and 24 | Relapse was defined as the development of new or the exacerbation of existing neurological symptoms or signs, in the absence of fever, lasting for 24 hours and with a previous period for more than 30 days with a stable or an improving condition. |
| Secondary | Annualized Relapse Rate at Month 12 and 24 | Month 12 and 24 | Relapse was defined as the development of new or the exacerbation of existing neurological symptoms or signs, in the absence of fever, lasting for 24 hours and with a previous period for more than 30 days with a stable or an improving condition. Annualized relapse rate was calculated by dividing the total number of relapse events by the total number of days subjects participated in the study. This number was then multiplied by 365.25 to get an annualized rate. |
| Secondary | Total Number of Reported Relapses at Month 3, 6, 12 and 24 | Month 3, 6, 12 and 24 | Relapse was defined as the development of new or the exacerbation of existing neurological symptoms or signs, in the absence of fever, lasting for 24 hours and with a previous period for more than 30 days with a stable or an improving condition. |
| Secondary | Percentage of Subjects Treated With Glucocorticoids Due to Relapses During 24 Months | Baseline up to Month 24 | Relapse was defined as the development of new or the exacerbation of existing neurological symptoms or signs, in the absence of fever, lasting for 24 hours and with a previous period for more than 30 days with a stable or an improving condition. Percentage of subjects treated with glucocorticoids due to relapses during 24 Months were reported here. |
| Secondary | Percentage of Subjects Free From Expanded Disability Status Scale (EDSS) Progression at Month 12 and 24 | Month 12 and 24 | Disability progression was assessed using EDSS. EDSS is based on a standardized neurological exam and focuses on symptoms that commonly occur in multiple sclerosis (MS) . Overall scores ranges from 0.0 (normal) to 10.0 (death due to MS). Disability progression was defined as an increase of EDSS score of at least 1.0 point compared to baseline for subjects with an EDSS =\< 4.0. For subjects with an EDSS= 0 at baseline, EDSS progression was defined as an increase of EDSS score of at least 1.5 point. Percentage of subjects free from EDSS progression at Month 12 and 24 were reported |
| Secondary | Hazard Ratio for Time to First Sustained Expanded Disability Status Scale (EDSS) Progression | Baseline to date at which the first confirmed EDSS progression occurs, assessed up to 24 months | EDSS progression is based on a standardized neurological exam and focuses on symptoms that commonly occur in MS. Overall scores ranges from 0.0 (normal) to 10.0 (death due to MS). A sustained progression on EDSS score was defined as an EDSS progression confirmed into two consecutive assessment. EDSS values obtained during clinical attacks are not excluded for the assessment of EDSS progression. However, EDSS values obtained during MS attacks that are not confirmed after two consecutive assessments will be excluded from statistical analysis of confirmed EDSS progression. Hazard ratio for time to first sustained EDSS progression was planned to be reported as per SAP. |
| Secondary | Percentage of Subjects With Active (New/Enlarging) T2 Lesions at Month 24 | Month 24 | A single T2 lesion was defined as an area of increased signal on a given 3-millimeters axial image that was not referable to normally hyperintense structures. New T2 lesions were those that appear in areas where on the previous scan no abnormality was detected. All T2 lesions were detected by an MRI scan. |
| Secondary | Percentage of Subjects With Combined Unique Active (CUA) Lesions at Month 12 and 24 | Month 12 and 24 | CUA lesion was defined as new gadolinium (Gd)-enhancing lesions on T1-weighted, or new or enlarging lesions on T2-weighted MRI scans, without double counting. |
| Secondary | Mean Number of New Gadolinium (Gd)-Enhancing Lesions at Month 12 and 24 | Month 12 and 24 | New Gd-enhancing Lesions are a measure of inflammatory activity and were assessed using the Magnetic Resonance Imaging (MRI) scan. |
| Secondary | Mean Number of New T1 (Hypointense) Lesions at Month 12 and 24 | Month 12 and 24 | Mean number of new T1 (Hypointense) Lesions represents a measure of accumulation of inflammatory disease burden assessed on magnetic resonance imaging (MRI) scans. |
| Secondary | Cumulative Number of New T1 (Hypointense) Lesions | Baseline up to Month 24 | Cumulative number of new T1 (Hypointense) lesions were reported. |
| Secondary | Median Change From Baseline in Whole Brain Volume at Month 12 and 24 | Baseline, Month 12 and 24 | Brain tissue volumes are inter-related and represent a measure of neurodegenerative aspects of the disease. |
| Secondary | Median Change From Baseline in Regional Brain Volume at Month 12 and 24 | Baseline, Month 12 and 24 | Brain tissue volumes are inter-related and represent a measure of neurodegenerative aspects of the disease. |
| Secondary | Flu-like Symptoms (FLS) Assessed by FLS Scale Score | Screening, Baseline, Month 3, 6, 12 and 24 | Flu-like symptoms were measured using FLS score in which subjects were scored as per the presence and intensity of muscle aches, chills, and weakness, each separately, on a scale of 0-3 as follows: 0 = absent; 1 = mild, do not interfere with daily activities; 2 = moderate, sufficient to interfere with daily activities; and 3 = severe, bed rest require. Body temperature also was also recorded to determine the presence of fever using the following scale: 0 (≤ 37.2 °C); 1 (≥ 37.3 °C but \< 37.8 °C); 2 (≥ 37.8 but \< 38.4 °C); and 3 (≥ 38.4 °C).The scores for each symptom (muscle aches, chills, weakness, body temperature) was added together to provide the combined flu-like symptom score ranging from 0 to 12 where 0 indicates absence of any symptom and 12 indicates the worst severity of the symptoms. |
| Secondary | Number of Subjects With Treatment Emergent Adverse Event (TEAE), Serious AE (SAE), TEAE Leading to Death and Discontinuation | Baseline up to Month 24 | AE was defined as any untoward medical occurrence which does not necessarily have a causal relationship with the study drug. An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious AE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent are events between first dose of study drug and up to 24 months. TEAEs include both Serious TEAEs and non-serious TEAEs. |
| Secondary | Number of Subjects With Clinical Significant Abnormality in Laboratory Parameters | From screening up to Month 24 | Laboratory assessment included haematology, chemistry, and urinalysis. Clinical significance was determined by the investigator. |
| Secondary | Number of Subjects With One Concomitant Medication From Baseline up to Month 24 | Baseline up to Month 24 | Number of subjects with at least one concomitant medication from baseline up to month 24 were reported. |
| Secondary | Time on Treatment (Adherence to Treatment) | Baseline up to 2.2 years | Time up to which subjects were adhered to the treatment was reported. |
| Secondary | Number of Subjects With Premature Termination From Treatment | Baseline up to Month 24 | Number of subjects with premature termination from treatment were reported. |
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.
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