Recombinant Human Relaxin in the Treatment of Diffuse Scleroderma

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00704665
• Date of registration: 23/06/2008
• Prospective Registration: No
• Primary sponsor: University of Medicine and Dentistry of New Jersey
• Public title: Recombinant Human Relaxin in the Treatment of Diffuse Scleroderma
• Scientific title: A Randomized, Double-Blind, Placebo-Controlled Trial of Recombinant Human Relaxin in the Treatment of Systemic Sclerosis With Diffuse Scleroderma
• Date of first enrolment: December 1998
• Target sample size: 231
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00704665
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 3

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Systemic Sclerosis

Intervention(s)

Drug: Relaxin

Primary Outcome(s)

MRSS [Time Frame: baseline, weeks 4,12, and 24]

Secondary Outcome(s)

HAQ-DI [Time Frame: baseline, weeks 4, 12, and 24]

Secondary ID(s)

2773

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of California, San Diego

Medical University of South Carolina

University of Colorado, Denver

Medical College of Wisconsin

Georgetown University

Johns Hopkins University

Stanford University

University of Pittsburgh

Boston University

University of California, Los Angeles

University of Chicago

University of Connecticut Health Center

Wayne State University