Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00704665
Other study ID # 2773
Secondary ID
Status Completed
Phase Phase 3
First received June 23, 2008
Last updated June 24, 2008
Start date December 1998
Est. completion date December 2001

Study information

Verified date June 2008
Source Rutgers, The State University of New Jersey
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Relaxin is a naturally occurring protein prduced by the ovary or placenta in pregnancy. It has ani-fibrotic properties. Previous studies have shown that relaxin is safe at concentrations upto 60 times higher than achieved in pregnancy. Study is designed to see if skin improvement and improvement in functional ability can be achieved.


Recruitment information / eligibility

Status Completed
Enrollment 231
Est. completion date December 2001
Est. primary completion date December 2001
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Men and women 18 to 70 years of age with diffuse SSc

- Disease duration 5 years since the onset of the first non-Raynaud sign or symptom

- A baseline modified Rodnan skin score (MRSS) of 20 or greater, or at least 16 if truncal involvement was present.

- Recombinant human relaxin (10 or 25 ug/kg/day), or placebo was administered for 24 weeks as a continuous subcutaneous infusion and there was a follow-up safety visit at week 28.

Study Design

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


Intervention

Drug:
Relaxin
10 ug/kg/day or 25 ug/kg/day
Relaxin
Placebo

Locations

Country Name City State
n/a

Sponsors (14)

Lead Sponsor Collaborator
University of Medicine and Dentistry of New Jersey Boston University, Georgetown University, Johns Hopkins University, Medical College of Wisconsin, Medical University of South Carolina, Stanford University, University of California, Los Angeles, University of California, San Diego, University of Chicago, University of Colorado, Denver, University of Connecticut Health Center, University of Pittsburgh, Wayne State University

Outcome

Type Measure Description Time frame Safety issue
Primary MRSS baseline, weeks 4,12, and 24 No
Secondary HAQ-DI baseline, weeks 4, 12, and 24 No
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