NCT01881529

Brief Summary

To treat patients with scleroderma by blocking the expression of LOXL2. The investigators first need to confirm (through observation) that LOXL2 is overexpressed in disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

April 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 19, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

April 17, 2014

Status Verified

April 1, 2014

Enrollment Period

11 months

First QC Date

June 5, 2013

Last Update Submit

April 16, 2014

Conditions

Limited SclerodermaDiffuse Scleroderma

Keywords

limited sclerodermadiffuse sclerodermaSclerosisProgressiveLimited

Outcome Measures

Primary Outcomes (1)

  • Summarized the number and percentage of subjects with elevated LOXL2 levels

    Baseline

Study Arms (2)

Limited Scleroderma

Diffuse Scleroderma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult subjects with documented diagnoses of scleroderma will be enrolled into one of two cohorts, depending upon the subject's diagnosis

You may qualify if:

  • Over 18 years of age
  • Documented diagnosis of scleroderma
  • Willing and able to provide written informed consent

You may not qualify if:

  • Use of experimental therapies within 28 days prior to Screening.
  • Aspirin use \> 81 mg daily within 1 week prior to Screening.
  • Any lab abnormality or concurrent medical condition that, in the opinion of the investigator would make the patient ineligible for the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Vincent's Centre for Applied Medical Research

Darlinghurst, New South Wales, 2010, Australia

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

* 5 mL blood draw for LOXL2 testing * 2 Punch Skin Biopsies (one near the scleroderma lesion, the other from normal skin)

MeSH Terms

Conditions

Scleroderma, LimitedScleroderma, DiffuseSclerosis

Condition Hierarchy (Ancestors)

Scleroderma, SystemicConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Bittoo Kanwar, MD

    Gilead Sciences

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2013

First Posted

June 19, 2013

Study Start

April 1, 2013

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

April 17, 2014

Record last verified: 2014-04

Locations

AU(1)