Table 1.
Main ongoing phase II/III clinical trials on systemic sclerosis
| Title | Primary outcome | Reference |
|---|---|---|
| Efficacy and Safety of riociguat in patients with systemic sclerosis | Change in mRSS | NCT02283762 |
| Proof-of-concept trial of IVA337 in diffuse cutaneous systemic sclerosis (FASST) | Change in mRSS | NCT02503644 |
| IVIG treatment in systemic sclerosis | Change in mRSS | NCT01785056 |
| A study of the efficacy and safety of tocilizumab in participants with Systemic Sclerosis (SSc) (focuSSced) | Change in mRSS | NCT02453256 |
| A Study of subcutaneous abatacept to treat diffuse cutaneous Systemic Sclerosis (ASSET) | Incidence of adverse events/change in mRSS | NCT02161406 |
| IL1-TRAP, Rilonacept, in Systemic Sclerosis | 4-gene skin biomarker | NCT01538719 |
| Cyclophosphamide systemic sclerosis-associated interstitial lung disease | Forced vital capacity | NCT01570764 |
| Rituximab versus cyclophosphamide in connective tissue disease-ILD (RECITAL) | Absolute change in FVC | NCT01862926 |
| A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis | Annual rate of decline in FVC in mL | NCT02597933 |
| Scleroderma treatment with autologous transplant (STAT) study | Event-free survival | NCT01413100 |
| Autologous stem cell SSc immune suppression trial (DIScl2011) | Time to treatment failure | NCT01445821 |
| Allogeneic hematopoietic cell transplantation after non-myeloablative conditioning for patients with severe Systemic Sclerosis | Event-free survival | NCT00622895 |
| Clinical trial of probiotics in Systemic Sclerosis associated gastrointestinal disease | Gastrointestinal change score | NCT01804959 |
| Gastroesophageal reflux treatment in scleroderma (GERD-SSc) | Change in severity of heart burn and regurgitation | NCT01878526 |
| Rituximab for treatment of Systemic Sclerosis-Associated pulmonary arterial hypertension (SSc-PAH) | Change in pulmonary vascular resistance | NCT01086540 |
| Early treatment of borderline pulmonary arterial hypertension associated with Systemic Sclerosis (SSc-APAH) (EDITA) | Mean pulmonary arterial pressure change from baseline | NCT02290613 |
| Zibotentan better renal scleroderma outcome study (ZEBRA) | Biomarker (sVCAM 1) | NCT02047708 |
| Safety, tolerability, efficacy, and pharmacokinetics of JBT-101 in systemic sclerosis (resunab: endocannabinoid-mimetic drug) | Treatment emergent adverse events and CRISS | NCT02465437 |
| Subcutaneous injection of autologous adipose tissue-derived stromal vascular fraction into the fingers of patients with systemic sclerosis (scleradec2) | Cochin hand functional scale | NCT02558543 |
CRISS, Combined Response Index for Systemic Sclerosis; mRSS, modified Rodnan skin score.