Trial · NCT02728752
Outcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Measure the Number of Patients Who Had an Increase of ≥20 Points on the Total Improvement Score (TIS) | At week 16 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Proportion of TIS Responders by Improvement Category at Week 16 | 16 weeks | Only responders are displayed as the intent of the outcome measure is to present the proportion of responders. And patients not accounted for were non-responders. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of TIS Responders by Improvement Category at Week 40 | 40 weeks | Only responders are displayed as the intent of the outcome measure is to present the proportion of responders. And patients not accounted for were non-responders. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Change From Baseline (Week 0) to End of First Period (Week 16) in the Modified Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) | First 16 weeks | units on a scale | MEAN | |
| SECONDARY | Mean Change From End of First Period (Week 16) to End of Extension Period (Week 40) in the Modified Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) | From week 16 to Week 40 | units on a scale | MEAN | |
| SECONDARY | Mean Change From Baseline (Week 0) to End of Extension Period (Week 40) in the Modified Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) | 40 weeks | units on a scale | MEAN | |
| SECONDARY | Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in: SF-36v2 Health Survey | From start of the trial till Week 40 | Numbers of patients analyzed different due to patient discontinuations through study. | units on a scale | MEAN |
| SECONDARY | Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in Physician's Global Disease Activity | From start of the trial till Week 40 | Different numbers of patients analyzed in each group due to patient discontinuation. | score on a scale | MEAN |
| SECONDARY | Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in: Patient Global Disease Activity | From start of the trial till Week 40 | Different numbers of patients analyzed in each group due to patient discontinuation. | score on a scale | MEAN |
| SECONDARY | Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in: MMT-8 | From start of the trial till Week 40 | Different numbers of patients analyzed in each group due to patient discontinuation. | score on a scale | MEAN |
| SECONDARY | Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in: Health Assessment Questionnaire | From start of the trial till Week 40 | Different numbers of patients analyzed in each group due to patient discontinuation. | score on a scale | MEAN |
| SECONDARY | Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in Enzymes (Alanine Aminotransferase) | From start of the trial till Week 40 | Different numbers of patients analyzed in each group due to patient discontinuation. | U/L | MEAN |
| SECONDARY | Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in Enzymes (Aspartate Aminotransferase) | From start of the trial till Week 40 | Different numbers of patients analyzed in each group due to patient discontinuation. | U/L | MEAN |
| SECONDARY | Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in Enzymes (Lactate Dehydrogenase) | From start of the trial till Week 40 | Different numbers of patients analyzed in each group due to patient discontinuation. | U/L | MEAN |
| SECONDARY | Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in Enzymes (Aldolase) | From start of the trial till Week 40 | Different numbers of patients analyzed in each group due to patient discontinuation. | U/L | MEAN |
| SECONDARY | Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in Enzymes (Creatine Kinase) | From start of the trial till Week 40 | Different numbers of patients analyzed in each group due to patient discontinuation. | U/L | MEAN |
| SECONDARY | Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in: Extra-muscular Activity | From start of the trial until Week 40 | Different numbers of patients analyzed in each group due to patient discontinuation. | units on a scale | MEAN |
| SECONDARY | Mean TIS From Baseline (Week 0) to End of First Period (Week 16) and From Baseline (Week 0) to End of Extension Period (Week 40) | Up to 40 weeks | Different numbers of patients analyzed in each group due to patient discontinuation. | units on a scale | MEAN |
| SECONDARY | Time to Minimal, Moderate and Major Improvement in TIS | Up to 40 weeks | Number of participants based on number of responders. 95% confidence interval not available for all measurements. | days | MEDIAN |
| SECONDARY | Time to Confirmed Deterioration in the First Period and Overall | Up to 40 weeks | All patients analyzed and only those that had confirmed deterioration are presented. | days | MEDIAN |
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/NCT02728752/outcomes