Trial · NCT00835770
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (AEs) | Day 1 up to Week 561 | An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. |
| Secondary | Percentage of Participants Who Had Relapses | Day 1 up to Week 384 | Relapses were defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours. |
| Secondary | Annualized Relapse Rate (ARR) | Day 1 up to Week 384 | The annualized relapse rate is calculated as the total number of relapses occurred during the period for all participants, divided by the total number of participant-years followed in the period. |
| Secondary | Change From Baseline in the Expanded Disability Status Scale (EDSS) at Week 384 | Baseline, Week 384 | EDSS scale ranges from 0 (Normal neurological exam, no disability) to 10 (Death) in 0.5 unit increments that represent higher levels of disability. Scoring is based on an examination by a neurologist. Sustained disability progression was defined as at least a 1.0 point increase on the EDSS from a baseline EDSS ≥1.0 that was sustained for at least 24 weeks, or a 1.5 point increase on the EDSS from a baseline EDSS =0 that was sustained for at least 24 weeks. |
| Secondary | Number of Gadolinium (Gd)-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Baseline up to Week 288 | The Gd-enhancing lesions was evaluated using MRI technique. |
| Secondary | Volume of Gd-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Baseline up to Week 288 | The Gd-enhancing lesions was evaluated using MRI technique. |
| Secondary | Number of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Baseline up to Week 288 | The T2 lesions was evaluated using MRI technique. |
| Secondary | Volume of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Baseline up to Week 288 | The T2 lesions was evaluated using MRI technique. |
| Secondary | Number of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Baseline up to Week 288 | The T1 hypointense lesions was evaluated using MRI technique. |
| Secondary | Volume of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Baseline up to Week 288 | The T1 hypointense lesions was evaluated using MRI technique. |
| Secondary | Percent Change From Baseline in Brain Atrophy | Baseline up to Week 288 | Brain atrophy was measured using magnetic resonance imaging (MRI) technique. |
| Secondary | Percent Change From Baseline in Magnetization Transfer Ratio (MTR) | Baseline up to Week 288 | Magnetization Transfer Ratio (MTR) was measured using MRI technique. |
| Secondary | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Baseline, Week 384 | The SF-36 is a brief (36-item) scale reflecting the impact of both dysfunctions and general health perception the questionnaire measures: 1.physical function (PF),2. role physical (RF),3. bodily pain (BP),4. role emotional (RE),5. social function (SF), 6. general health (GH),7. vitality (VT), 8. mental health (MH). Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the mental component summary (MCS) score of the SF-36. The questions related to each dimension are scored on a scale from 0 (worst score) to 100 (best score), with higher scores indicating better function. |
| Secondary | Change From Baseline in EuroQol 5 Dimensions Questionnaire (EQ-5D) Health Survey - EQ-5D Index Score at Week 384 | Baseline, Week 384 | The EQ-5D is a generic health-related quality of life instrument consisting of 2 components, EQ-5D index score and EQ-VAS. The EQ-5D provides a profile of the participant's health state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each dimension, the participant is instructed to indicate whether he or she has (1) "no problems", (2) "some problems", or (3) "severe problems". A positive change from baseline indicates improvement. |
| Secondary | Change From Baseline in EuroQol 5 Dimensions Questionnaire (EQ-5D) Health Survey - Visual Analog Scale (VAS) at Week 384 | Baseline, Week 384 | The EQ-5D is a generic health-related quality of life instrument consisting of 2 components, EQ-5D index score and EQ-VAS. In EQ-VAS participants are asked to rate their current health on a 20 centimeter (cm) scale from 0 to 100 where 0 represents "worst imaginable health state" and 100 represents "best imaginable health state". A positive change from baseline indicates improvement. |
| Secondary | Change From Baseline in Visual Function Test Scores at Week 384 | Baseline, Week 384 | Participants were tested using the contrast level of 100%, 2.5%, and 1.25% charts, and the scores were defined as the number of letters identified correctly for each chart (the maximum score was 60). Higher scores indicate better functioning. A positive change from baseline indicates better functioning. |
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/NCT00835770/registered