Phase 2 N=20 Belimumab for the Treatment of Diffuse Cutaneous Systemic Sclerosis
Systemic Sclerosis
Primary: Change in Modified Rodnan Skin Score (MRSS) — -10; -3.0 units on a scale
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Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 2 N=97 Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic Sclerosis
Systemic Sclerosis
Primary: Change From Baseline in Modified Rodnan Skin Score to Week 24 — -2.45; -4.76 score on a scale — p=0.0291
Phase 3 N=6 High Dose Cyclophosphamide for Treatment of Scleroderma
Scleroderma
Primary: Improvement in the Modified Rodnan Skin Score. — 46.75 percent improvement from baseline
Phase 2 N=88 A Study of Subcutaneous Abatacept to Treat Diffuse Cutaneous Systemic Sclerosis
Diffuse Cutaneous Systemic Sclerosis
Primary: Proportion of Participants With at Least One Adverse Events (AEs) or Serious AEs (SAEs) in 1 Year — 35; 40 Participants
Phase 2 N=10 A Study to Evaluate the Safety and Efficacy of Abatacept in Patients With Diffuse Systemic Sclerosis (Scleroderma)
Scleroderma, Diffuse · Scleroderma, Systemic
Primary: Change in Modified Rodnan Skin Score — -8.6; -2.3 MRSS score
N/A N=15 Study of Ambrisentan With Antifibrotic Agent Combination Therapy in Diffuse Systemic Sclerosis
Systemic Sclerosis · Scleroderma
Primary: The Benefit That an Antifibrotic Agent and Ambrisentan Combination Have on the Cutaneous Involvement of Patients With Early Diffuse Systemic Sclerosis by Utilizing the…
Phase 2 N=76 Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Diffuse Cutaneous Systemic Sclerosis
Diffuse Cutaneous Systemic Sclerosis
Primary: The ACR CRISS Composite Score (0-1) at Week 52 — 0.8537; 0.8502 scores on ascale
Phase 2 N=15 Evaluation of Tofacitinib in Early Diffuse Cutaneous Systemic Sclerosis (dcSSc)
Systemic Sclerosis · Scleroderma
Primary: Number of Participants Who Experience Grade 3 or Higher Adverse Events That Occur at or Before Week 24 — 0; 0 Participants
Phase 2 N=142 Comparison of Therapeutic Regimens for Scleroderma Interstitial Lung Disease (The Scleroderma Lung Study II)
Scleroderma · Interstitial Lung Disease
Primary: Forced Vital Capacity (FVC), as a Percent of the Age, Height, Gender, and Ethnicity Adjusted Predicted Value — 66.52; 66.52; 66.22; 67.03 FVC %-pred — p=0.24
Phase 2 N=9 Imatinib in Systemic Sclerosis
Scleroderma, Systemic
Primary: Percent Change in Modified Rodnan Skin Score at 6 Months Compared to Baseline — -32 percentage of change in MRSS — p=0.005
Phase 2 N=19 IL1-TRAP, Rilonacept, in Systemic Sclerosis
Scleroderma · Systemic Sclerosis · Diffuse Scleroderma
Primary: Change in 2- Gene Biomarker — -2.67; 0.42 2- gene biomarkers score
Phase 2 N=35 Proof of Mechanism Study of GSK2330811 in Diffuse Cutaneous Systemic Sclerosis
Scleroderma, Systemic
Primary: Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) — 8; 3; 24; 1 Participants
Phase 2 N=12 Systemic Sclerosis (SSc) Vasculopathy: Improved Clinical Monitoring and Treatment
Rheumatologic Disease
Primary: Flow Mediated Dilatation (FMD)-Diameter of Artery — 3.79; 3.78 mm
Phase 2 N=19 Cyclophosphamide and rATG With Hematopoietic Stem Cell Support in Systemic Scleroderma
SYSTEMIC SCLERODERMA
Primary: Time to Treatment Failure — 0; 8 participants
Phase 2 N=17 Brentuximab Vedotin for Systemic Sclerosis
Diffuse Cutaneous Systemic Sclerosis · Scleroderma · dcSSc
Primary: Proportion of Participants That Experience at Least One Grade 3 or Higher Adverse Event at or Before Week 48. — 0.333; 0.000; 0.571; 0.000 Proportion of participants…
N/A N=27 Hands on - a Hand Care Guide in Systemic Sclerosis
Scleroderma
Primary: Cochin Hand Functional Scale — 19.24 units on a scale
Phase 3 N=158 Scleroderma Lung Disease
Lung Diseases · Pulmonary Fibrosis · Systemic Scleroderma
Primary: Forced Vital Capacity — 66.6; 65.6 % of predicted
N/A N=45 Scleroderma ARFI Imaging of the Skin
Scleroderma
Primary: Mean Skin Stiffness — 2.68; 2.07; 2.23; 2.27 meters per second — p=0.005
Phase 3 N=41 Effect of Sildenafil on the Microcirculatory Blood Flow and Endothelial Progenitor Cells in Systemic Sclerosis
Scleroderma, Systemic · Scleroderma, Diffuse · Scleroderma, Limited
Primary: Digital Skin Microvascular Blood Flow Measured by Laser Doppler Imaging (LDI) Before Cold Stimulus — 260.0; 246.3 perfusion units
Phase 3 N=289 Macitentan for the Treatment of Digital Ulcers in Systemic Sclerosis Patients
Systemic Sclerosis · Ulcers
Primary: Incidence Rate of New Digital Ulcers (DUs) up to Week 16 — 0.9082; 0.9567; 0.8115 number of new DUs/observation days — p=0.706
Phase 2 N=56 A Study of Guselkumab in Participants With Systemic Sclerosis
Scleroderma, Systemic
Primary: Main Study: Change From Baseline in Modified Rodnan Skin Score (mRSS) at Week 24 — -9.5; 3.1 Score on a scale — p=< 0.001
Phase 3 N=580 A Trial to Compare Nintedanib With Placebo for Patients With Scleroderma Related Lung Fibrosis
Scleroderma, Systemic
Primary: Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks — -93.3; -52.4 millilitre (mL)/year (yr) — p=0.0350
Phase 2 N=27 Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults With Systemic Sclerosis (SSc)
Diffuse Cutaneous Systemic Sclerosis
Primary: Number of Participants With at Least One Adverse Event (AE) for IgPro20 — 9; 9 Participants
Phase 2 N=24 Atorvastatin for Microvascular Endothelial Function and Raynaud in Early Diffuse Scleroderma
Scleroderma
Primary: Proportion of Patients Improving Their EndoPAT Reactive Hyperemia Index (RHI) at the End-of-study (16 Weeks) — 6; 4 Participants
Phase 2 N=57 Rituximab for Treatment of Systemic Sclerosis-Associated Pulmonary Arterial Hypertension (SSc-PAH)
Systemic Sclerosis-Associated PAH
Primary: Change From Baseline in Distance Walked During a Six Minute Walk Test — 23.6; 0.5 Meters — p=0.12
Phase 2 N=21 Scleroderma Treatment With Autologous Transplant (STAT) Study
Systemic Scleroderma
Primary: EFS of Patients Undergoing Transplant — 15 participants
N/A N=20 A Study to Evaluate the Efficacy of an Oral Medication in the Treatment and Prevention of Digital Ulcers in Patients With Systemic Sclerosis (Scleroderma).
n Ulcer · Scleroderma, Systemic
Primary: New Digital Ulcers (DU) 4 Weeks Prior to Week 24 — 0.06 new digital ulcers
Phase 2 N=121 Efficacy and Safety of Riociguat in Patients With Systemic Sclerosis
Scleroderma, Systemic
Primary: Change From Baseline in Modified Rodnan Skin Score (mRSS) to Week 52 — -2.088; -0.769 score on a scale — p=0.0815
Phase 2 N=30 Imatinib Mesylate (Gleevec) in the Treatment of Systemic Sclerosis
Systemic Sclerosis
Primary: Improvement in the Modified Rodnan Skin Score — -6.6 units on a scale
Phase 2 N=6 An Open-label, Phase 2 Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Systemic Sclerosis
Systemic Sclerosis
Primary: Change From Baseline in Modified Rodnan Total Skin Thickness Score (Total mRSS) at Week 24 — -9.5 scores on scale