NCT00704665

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
231

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 1998

Typical duration for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1998

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2001

Completed
6.6 years until next milestone

First Submitted

Initial submission to the registry

June 23, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 25, 2008

Completed
Last Updated

June 25, 2008

Status Verified

June 1, 2008

Enrollment Period

3 years

First QC Date

June 23, 2008

Last Update Submit

June 24, 2008

Conditions

Systemic Sclerosis

Keywords

Diffuse SclerodermaSkin score

Outcome Measures

Primary Outcomes (1)

  • MRSS

    baseline, weeks 4,12, and 24

Secondary Outcomes (1)

  • HAQ-DI

    baseline, weeks 4, 12, and 24

Study Arms (2)

2

PLACEBO COMPARATOR

Placebo

Drug: Relaxin

A

EXPERIMENTAL

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

Drug: Relaxin

Interventions

RelaxinDRUG

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

A

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Scleroderma, SystemicScleroderma, Diffuse

Interventions

Relaxin

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Intervention Hierarchy (Ancestors)

Corpus Luteum HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptide HormonesPeptidesAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 23, 2008

First Posted

June 25, 2008

Study Start

December 1, 1998

Primary Completion

December 1, 2001

Study Completion

December 1, 2001

Last Updated

June 25, 2008

Record last verified: 2008-06