Diffuse Cutaneous Systemic Sclerosis
Conditions
Brief summary
Change in FVC % predicted from Baseline to Week 52
Detailed description
1.Change from Baseline in HAQ-DI at Week 52. 2.Change from Baseline in MDGA at Week 52. 3.Change from Baseline in PTGA at Week 52. 4.Change from Baseline in the Physical Effects subscale of the SSPRO-18 at Week 52. 5.Change from Baseline in the Physical Limitations subscale of the SSPRO-18 at Week 52. 6.Proportion of subjects with an mRSS decrease of ≥5 points and 25% from Baseline at Week 52. Please refer to protocol section 8.2
Interventions
Sponsors
Horizon Therapeutics Ireland Designated Activity Company
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in FVC % predicted from Baseline to Week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Change from Baseline in HAQ-DI at Week 52. 2.Change from Baseline in MDGA at Week 52. 3.Change from Baseline in PTGA at Week 52. 4.Change from Baseline in the Physical Effects subscale of the SSPRO-18 at Week 52. 5.Change from Baseline in the Physical Limitations subscale of the SSPRO-18 at Week 52. 6.Proportion of subjects with an mRSS decrease of ≥5 points and 25% from Baseline at Week 52. Please refer to protocol section 8.2 | — |
Countries
Austria, France, Germany, Greece, Italy, Poland, Portugal, Romania, Spain
Outcome results
None listed