Trial · NCT01480076
Outcomes35
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 35
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in the Physical Component Scale (PCS) of the Short Form 36 Health Status Questionnaire (SF-36) At Months 3, 6, 9, and 12: Responders | Baseline, Months 3, 6, 9, 12 | Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the PCS of the SF-36 at Months 3, 6, 9, and 12: Responders Versus Non-responders | Baseline, Months 3, 6, 9, 12 | Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the MCS of the SF-36 At Months 3, 6, 9, and 12 | Baseline, Months 3, 6, 9, 12 | Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Multiple Sclerosis Impact Scale (MSIS-29) Physical Score at Months 3, 6, 9, and 12 | Baseline, Months 3, 6, 9, 12 | Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in MSIS-29 Psychological Score at Months 3, 6, 9, and 12 | Baseline, Months 3, 6, 9, 12 | Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Activities Limitation Scale of the Patient-Reported Indices for Multiple Sclerosis (PRIMUS) at Months 3, 6, 9, and 12 | Baseline, Months 3, 6, 9, 12 | Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Current Health State of EuroQoL Descriptive System of Health-related Quality of Life States Consisting of 5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Months 3, 6, 9, And 12 | Baseline, Months 3, 6, 9, 12 | Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Index Scores of EQ-5D at Months 3, 6, 9, and 12 | Baseline, Months 3, 6, 9, 12 | Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Percent Work Time Missed Due to MS, by the Work Productivity and Activity Impairment-Specific Health Problem (WPAI-SHP) Questionnaire at Months 3, 6, 9, and 12 | Baseline, Months 3, 6, 9, 12 | Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis. | percentage of work time missed | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Percent Impairment While Working Due to MS, by the WPAI-SHP Questionnaire at Months 3, 6, 9, and 12 | Baseline, Months 3, 6, 9, 12 | Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis. | percentage of impairment while working | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Percent Overall Work Impairment Due to MS, by the WPAI-SHP Questionnaire at Months 3, 6, 9, and 12 | Baseline, Months 3, 6, 9, 12 | Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis. | percentage of overall work impairment | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Regular Activity Productivity Loss, by the WPAI-SHP Questionnaire at Months 3, 6, 9, and 12 | Baseline, Months 3, 6, 9, 12 | Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis. | percentage of activity impairment | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the PCS of the SF-36 at Months 3, 6, 9, and 12 by MS Disease Type: Responders | Baseline, Months 3, 6, 9, and 12 | Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the MCS of the SF-36 at Months 3, 6, 9, and 12 by MS Disease Type: Responders | Baseline, Months 3, 6, 9, and 12 | Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the MSIS-29 Physical Score at Months 3, 6, 9, and 12 by MS Disease Type: Responders | Baseline, Months 3, 6, 9, and 12 | Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the MSIS-29 Psychological Score at Months 3, 6, 9, and 12 by MS Disease Type: Responders | Baseline, Months 3, 6, 9, and 12 | Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Activity Limitation Scale (ALS) of PRIMUS Score at Months 3, 6, 9, and 12 by MS Disease Type: Responders | Baseline, Months 3, 6, 9, and 12 | Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Current Health State of the EQ-5D VAS at Months 3, 6, 9, and 12 by MS Disease Type: Responders | Baseline, Months 3, 6, 9, and 12 | Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in EQ-5D Index Scores at Months 3, 6, 9, and 12 by MS Disease Type: Responders | Baseline, Months 3, 6, 9, and 12 | Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Percent Work Time Missed Due to MS on the WPAI-SHP Questionnaire at Months 3, 6, 9, and 12 by MS Disease Type: Responders | Baseline, Months 3, 6, 9, and 12 | Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis. | percentage of work time missed | LEAST_SQUARES_MEAN |
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/NCT01480076/outcomes