Phase II Study of Recombinant Relaxin for Progressive Systemic Sclerosis

Status Completed

Clinical Trial Summary

OBJECTIVES: I. Determine whether parenteral relaxin improves skin tightness, Raynaud's phenomenon, digital morbidity, and digital ulcers in a patient with progressive systemic sclerosis (scleroderma).

II. Determine whether relaxin decreases collagen production by fibroblasts in vivo and cultured from skin biopsies.

Clinical Trial Description

PROTOCOL OUTLINE: This is a compassionate use study. The patient is treated with subcutaneous injections of recombinant relaxin for approximately 12 months. If clinically indicated, therapy may be extended. ;

Study Design

Allocation: Non-Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00004380
Study type	Interventional
Source	Office of Rare Diseases (ORD)
Contact
Status	Completed
Phase	Phase 2
Start date	December 1991
Completion date	December 1997

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	`NCT05177380` - Efficacy of a Personalized Rehabilitation Program of Facial Involvement in Systemic Sclerosis	N/A
Not yet recruiting	`NCT04303208` - Sirtuin 3 and Sirtuin 7 in Systemic Sclerosis	N/A
Recruiting	`NCT02551042` - CSL Behring Sclero XIII	Phase 2
Terminated	`NCT02243111` - Detecting Pulmonary Arterial Hypertension (PAH) in Patients With Systemic Sclerosis (SSc) by Ultrasound	N/A
Terminated	`NCT02246348` - Evaluating Lung Doppler Signals in Patients With Systemic Sclerosis (SSc)	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