Phase II Study of Recombinant Relaxin for Progressive Systemic Sclerosis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00004380

Enrollment

Registered

1999-10-19

Start date

1991-12-31

Completion date

1997-12-31

Last updated

2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Sclerosis

Keywords

arthritis & connective tissue diseases, rare disease, systemic sclerosis

Brief 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.

Detailed 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.

Interventions

DRUGrelaxin

Study design

Allocation

NON_RANDOMIZED

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

0 Years to No maximum

Healthy volunteers

Inclusion criteria

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- * Progressive systemic sclerosis (scleroderma) * No pregnant or nursing women

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026