Clinical Trials Logo
  1. Home
  2. Systemic Sclerosis
  3. NCT00077584

Efficacy and Safety of Oral Bosentan on Healing/Prevention of Digital (Finger) Ulcers in Patients With Scleroderma — RAPIDS-2  

Systemic Sclerosis Clinical Trial

Official title:
A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Effect of Bosentan on Healing and Prevention of Ischemic Digital Ulcers in Patients With Systemic Sclerosis

Clinical Trial Summary

In an earlier clinical trial, RAPIDS-1, conducted in scleroderma patients with or without digital ulcers at baseline, bosentan significantly reduced the number of new digital ulcers versus placebo. The purpose of the present trial (RAPIDS-2) is to evaluate the prevention and healing effects of bosentan versus placebo on digital ulcers over a 24-week treatment period.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00077584
Study type Interventional
Source Actelion
Contact
Status Completed
Phase Phase 3
Start date October 2003
Completion date May 2005
View Details
See also
  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 Sclerosis−Related 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