Systemic Sclerosis Clinical Trial
Systemic sclerosis is an orphan, multiorgan disease affecting the connective tissue of the
skin and several internal organs.
Digital ulcers are frequent and have a major impact on the quality of life in patients with
systemic sclerosis. The etiology of digital ulcers is complex and multifactorial and the
principal mechanisms underlying the digital ulcers formation are ischemic, mechanic and
inflammatory, alone or in combination, on the basis of the systemic sclerosis vasculopathy.
Consequently, there are at least three types of DU: (i) those localized at the tips of the
fingers and toes, mainly resulting from an ischemic process, (ii) those localized on the
dorsal aspect of the fingers where the skin retraction due to fibrosis over bony prominences
seems to be the main cause, and (iii) those evolving on a pitting scar or subcutaneous
calcinosis due to a combined irritative-inflammatory mechanism. An early therapy to prevent
or rapidly heal digital ulcers is today considered a mandatory approach to maintain quality
of life and spare the enormous costs due to conventional digital ulcer management.
This observational trial is part of the collaborative project "DeSScipher", one out of five
observational trials to decipher the optimal management of systemic sclerosis.
Aim of this observational trial is:
1. To identify the best treatment combination for prevention of digital ulcers in patients
with fulfilment of the new ACR/EULAR SSc criteria or the preliminary VEDOSS criteria
for very early diagnosis of systemic sclerosis
2. To identify the best treatment associated with improved healing of digital ulcers in
patients with fulfilment of the new ACR/EULAR SSc criteria
Thus, the observational trial consist of a prevention arm and a healing arm.
n/a
Observational Model: Cohort, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03274076 -
Evaluation of Tofacitinib in Early Diffuse Cutaneous Systemic Sclerosis (dcSSc)
|
Phase 1/Phase 2 | |
| Completed |
NCT04300426 -
Safety and Efficacy of Anaerobic Cultivated Human Intestinal Microbiome Transplantation in Systemic Sclerosis (ReSScue)
|
Phase 2 | |
| Recruiting |
NCT06058091 -
RY_SW01 Cell Injection Therapy in Systemic Sclerosis
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04356755 -
Subcutaneous Injections of ASC to Heal Digital Ulcers in Patients With Scleroderma.
|
Phase 2 | |
| Suspended |
NCT06210945 -
Study to Evaluate the Safety, Tolerability, and Activity of CM-101 in Patients With Systemic Sclerosis
|
Phase 2 | |
| Not yet recruiting |
NCT05947682 -
Manufacturing of Allogeneic Adipose Tissue-derived Mesenchymal Stromal Cells for Treatment of Severe Systemic Sclerosis
|
N/A | |
| Not yet recruiting |
NCT04303208 -
Sirtuin 3 and Sirtuin 7 in Systemic Sclerosis
|
N/A | |
| Not yet recruiting |
NCT05177380 -
Efficacy of a Personalized Rehabilitation Program of Facial Involvement in Systemic Sclerosis
|
N/A | |
| Recruiting |
NCT02551042 -
CSL Behring Sclero XIII
|
Phase 2 | |
| Terminated |
NCT02246348 -
Evaluating Lung Doppler Signals in Patients With Systemic Sclerosis (SSc)
|
N/A | |
| Terminated |
NCT02243111 -
Detecting Pulmonary Arterial Hypertension (PAH) in Patients With Systemic Sclerosis (SSc) by Ultrasound
|
N/A | |
| Completed |
NCT01933334 -
Safety and Tolerability of Pirfenidone in Patients With Systemic SclerosisâRelated Interstitial Lung Disease (SSc-ILD) (LOTUSS)
|
Phase 2 | |
| Completed |
NCT01468792 -
Hemodynamic Changes in Connective Tissue Disease
|
N/A | |
| Terminated |
NCT00848107 -
Open-Label Study of Oral Treprostinil in Digital Ulcers
|
Phase 2 | |
| Completed |
NCT00984932 -
Effect of Rosuvastatin on Systemic Sclerosis-related Pulmonary Hypertension
|
Phase 3 | |
| Completed |
NCT00074568 -
Scleroderma Registry
|
||
| Not yet recruiting |
NCT06412614 -
Evaluation of Patients With Systemic Sclerosis Without Specific or Associated Autoantibodies
|
||
| Terminated |
NCT00622687 -
Effect of Different Iloprost Doses on Symptoms in Systemic Sclerosis
|
Phase 2 | |
| Recruiting |
NCT04464434 -
Upfront Autologous HSCT Versus Immunosuppression in Early Diffuse Cutaneous Systemic Sclerosis
|
Phase 4 | |
| Recruiting |
NCT04246528 -
SPIN Self-Management Feasibility Trial With Progression to Full-scale Trial (SPIN-SELF)
|
N/A |