Trial · NCT03181893
Outcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) Activity Score at Week 12 (Stage 1, Stage 2 and Amended Stage 2) | Baseline and Week 12 | The Full Analysis Set (FAS) in Stage 1, Stage 2, and Amended Stage 2 included all participants who received at least 1 dose of randomized treatment in in Stage 1, Stage 2, or Amended Stage 2. | Units on a scale | MEAN |
| PRIMARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAE) (Stage 3) | Up to Week 40 | The safety analysis set in Stage 3 (SAS3) included all participants who received at least 1 dose of randomized treatment in Stage 3. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Laboratory Abnormalities (Stage 3) | Up to Week 40 | The safety analysis set in Stage 3 (SAS3) included all participants who received at least 1 dose of randomized treatment in Stage 3. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Vital Sign Abnormalities (Stage 3) | Baseline up to Week 40 | The SAS3 included all participants who received at least 1 dose of randomized treatment in Stage 3. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Electrocardiogram (ECG) Abnormalities (Stage 3) | Baseline up to Week 40 | The SAS3 included all participants who received at least 1 dose of randomized treatment in Stage 3. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With TEAEs and SAEs (Stage 1 and Stage 2) | Up to Week 28 | The safety analysis set in Stage 1 (SAS1) and safety analysis set in Stage 2 (SAS2) included all participants who received at least 1 dose of randomized treatment in Stage 1 and Stage 2, respectively. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With TEAEs and SAEs (Amended Stage 2) | Up to Week 40 | The safety analysis set in Amended Stage 2 (SASA2) includes all participants who received at least one dose of randomized treatment in Amended Stage 2. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Laboratory Abnormalities (Stage 1 and Stage 2) | Up to Week 28 | The SAS1 and SAS2 included all participants who received at least 1 dose of randomized treatment in Stage 1 and Stage 2, respectively. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Laboratory Abnormalities (Amended Stage 2) | Up to Week 40 | The SASA2 includes all participants who received at least one dose of randomized treatment in Amended Stage 2. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Vital Sign Abnormalities (Stage 1 and Stage 2) | Up to Week 28 | The SAS1 and SAS2 included all participants who received at least 1 dose of randomized treatment in Stage 1 and Stage 2, respectively. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Vital Sign Abnormalities (Amended Stage 2) | Up to Week 40 | The SASA2 includes all participants who received at least one dose of randomized treatment in Amended Stage 2. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With ECG Abnormalities (Stage 1 and Stage 2) | Up to Week 28 | The SAS1 and SAS2 included all participants who received at least 1 dose of randomized treatment in Stage 1 and Stage 2, respectively. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With ECG Abnormalities (Amended Stage 2) | Up to Week 40 | The SASA2 includes all participants who received at least one dose of randomized treatment in Amended Stage 2. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in CDASI Activity Score at at All Scheduled Timepoints Through Week 12 (Stage 1, Stage 2 and Amended Stage 2) | Baseline, Week 1, Week 4, and Week 8 (except for Week 12 which is a primary outcome measure) | The FAS in Stage 1, Stage 2, and Amended Stage 2 included all participants who received at least 1 dose of randomized treatment in in Stage 1, Stage 2, or Amended Stage 2. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in CDASI Activity Score at All Scheduled Timepoints Through Week 12 (Stage 3) | Baseline, Week 1, Week 4, Week 8 and Week 12 | The Full Analysis Set in Stage 3 (FAS3) included all participants who received at least 1 dose of randomized treatment in Stage 3. | Units on a scale | MEAN |
| SECONDARY | Absolute Values of CDASI Activity Score at All Scheduled Timepoints Through Week 12 (All Stages) | Baseline, Week 1, Week 4, Week 8 and Week 12 | The FAS included all participants who received at least 1 dose of randomized treatment in any study stage. | Units on a scale | MEAN |
| SECONDARY | Absolute Values of CDASI Damage Score at All Scheduled Timepoints Through Week 12 (All Stages) | Baseline, Week 1, Week 4, Week 8 and Week 12 | The FAS included all participants who received at least 1 dose of randomized treatment in any study stage. | Units on a scale | MEAN |
| SECONDARY | Absolute Values for Total Improvement Score (TIS) at Week 12 and Intermediate Scheduled Time Points (Stage 3) | Week 4, Week 8 and Week 12 | The FAS3 included all participants who received at least 1 dose of randomized treatment in Stage 3. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Core Set Measures (CSM) of the TIS (Global Disease Activity [PhGA] and Extramuscular Global Assessment [EmGA]) (Stage 3) | Baseline, Week 4, Week 8 and Week 12 | The Full Analysis Set in Stage 3 (FAS3) included all participants who received at least 1 dose of randomized treatment in Stage 3. | Centimeter (cm) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the CSM of the TIS (PtGA) (Stage 3) | Baseline, Week 4, Week 8 and Week 12 | The FAS3 included all participants who received at least 1 dose of randomized treatment in Stage 3. | Millimeter (mm) | 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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03181893/outcomes