A Non-Interventional Pilot Study Assessing Whether Lysyl Oxidase-like 2 (LOXL2) is Present in Subjects With Scleroderma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01881529
First received: June 5, 2013
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

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.


Condition
Limited Scleroderma
Diffuse Scleroderma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: A Non-Interventional Pilot Study Assessing Whether Lysyl Oxidase-like 2 (LOXL2) is Present in Subjects With Scleroderma

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Summarized the number and percentage of subjects with elevated LOXL2 levels [ Time Frame: Baseline ] [ Designated as safety issue: No ]

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)

Enrollment: 29
Study Start Date: April 2013
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Limited Scleroderma
Diffuse Scleroderma

Detailed Description:

Scleroderma is a chronic skin-hardening disease. There are two types of scleroderma. The first type is called limited cutaneous scleroderma, where disrupted blood flow causes skin discoloration and sometimes patients experience high blood pressure in their arteries. The second type is called diffuse cutaneous scleroderma and it is much more aggressive, affecting a larger area of skin causing organ damage. This study will determine if the disease is associated with an elevated expression of LOXL2 levels in tissue samples from patients.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01881529

Locations
Australia, New South Wales
St Vincent's Centre for Applied Medical Research
Darlinghurst, New South Wales, Australia, 2010
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Bittoo Kanwar, MD Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01881529     History of Changes
Other Study ID Numbers: GS-US-321-0108
Study First Received: June 5, 2013
Last Updated: April 16, 2014
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Gilead Sciences:
limited scleroderma
diffuse scleroderma
Sclerosis
Progressive
Limited

Additional relevant MeSH terms:
Scleroderma, Systemic
Scleroderma, Diffuse
Scleroderma, Localized
Scleroderma, Limited
CREST Syndrome
Connective Tissue Diseases
Skin Diseases
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Raynaud Disease
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Telangiectasis
Calcinosis
Calcium Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 29, 2014