Recombinant Human Relaxin in the Treatment of Diffuse Scleroderma

University of Medicine and Dentistry of New Jersey

Status and phase: Completed; Phase 3

Conditions: Systemic Sclerosis

Treatments: Drug: Relaxin

Study type: Interventional

Funder types: Other

Identifiers

NCT00704665

2773

Details and patient eligibility

About

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.

Enrollment: 231 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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231 participants in 2 patient groups, including a placebo group

2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Relaxin

Drug: Relaxin

A

Experimental group

Description:

10ug/kg/day or 25/ug/kg/day

Treatment:

Drug: Relaxin

Drug: Relaxin