Trial · NCT02588625
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part A - Change in modified Rodnan skin score (mRSS) | Week 24 | |
| Primary | Part B - Change in modified Rodnan skin score (mRSS) | Week 48 | |
| Secondary | Part A: Change in physical function based on health assessment questionnaire-disability index from baseline at specified timepoints (HAQ-DI) | Week 4, 12 and 24 | |
| Secondary | Part A: Change in percent predicted forced vital capacity (FVC) from baseline at specified time points | Week 4, 12 and 24 | |
| Secondary | Part A: Proportion of subjects with ≥ 20%, 40%, or 60% change in mRSS from baseline at specified time points | Week 4, 12 and 24 | |
| Secondary | Part A: Change in subject's global assessment on a visual analog scale (VAS) from baseline at specified time points | Week 4, 12 and 24 | |
| Secondary | Part A: Change in physician's global assessment on a visual analog scale (VAS) from baseline at specified time points | Week 4, 12 and 24 | |
| Secondary | Part A: Safety as measured by the frequency of deaths, SAEs, drug related AEs, AEs leading to discontinuation as well as marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, physical examinations | up to Month 3 of the Follow-Up | Serious adverse event (SAE), Adverse event (AE) |
| Secondary | Part A: Tolerability as measured by the frequency of deaths, SAEs, drug related AEs, AEs leading to discontinuation as well as marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, physical examinations | up to Month 3 of the Follow-Up | |
| Secondary | Part B: Change in physical function based on health assessment questionnaire-disability index (HAQ-DI) | Week 48 | |
| Secondary | Part B: Change in percent predicted forced vital capacity | Week 48 | |
| Secondary | Part B:Proportion of subjects with ≥ 20%, 40%, or 60% change in mRSS from baseline at specified time points | Week 4, 12, 24, 36, and 48 | |
| Secondary | Part B: Proportion of subjects with > 10% absolute decline in % FVC | Week 48 | |
| Secondary | Part B:Proportion of subjects with % FVC change > 0 | Week 48 | |
| Secondary | Part B: Change in quantitative lung fibrosis (QLF) score on High resolution CT (HRCT) from baseline at specified time points | Week 48 | |
| Secondary | Part B: Change in subject's global assessment on a visual analog scale (VAS) from baseline at specified time points | Week 4, 12, 24, 36, and 48 | |
| Secondary | Part B: Change in physician's global assessment on a visual analog scale (VAS) from baseline at specified time points | Week 4, 12, 24, 36, and 48 | |
| Secondary | Part B: Change in health-related quality of life (HRQOL) using Patient Reported Outcomes Measurement Information System (PROMIS)-29 score from baseline at specified time points | Week 4, 12, 24, 36, and 48 | |
| Secondary | Part B: Safety as measured by the frequency of deaths, SAEs, drug related AEs, AEs leading to discontinuation as well as marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, physical examinations | up to Month 3 of the Follow-Up | |
| Secondary | Part B: Tolerability as measured by the frequency of deaths, SAEs, drug related AEs, AEs leading to discontinuation as well as marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, physical examinations | up to Month 3 of the Follow-Up |
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
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GET https://conductscience.org/api/trials/v1/NCT02588625/registered