NCT02562079

Brief Summary

It is a study of basic research with mechanistically objectives and including clinical biological samples.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
350

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2012

Longer than P75 for not_applicable

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

March 1, 2012

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

December 29, 2014

Completed
9 months until next milestone

First Posted

Study publicly available on registry

September 29, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

April 7, 2017

Status Verified

April 1, 2017

Enrollment Period

4.8 years

First QC Date

December 29, 2014

Last Update Submit

April 5, 2017

Conditions

Systemic Sclerosis

Keywords

T lymphocyteOX40/OX40L

Outcome Measures

Primary Outcomes (1)

  • Assessment of OX40L expression in endothelial cells and skin biopsies.

    Day 1

Study Arms (3)

subjects SSc diagnosed

EXPERIMENTAL
Biological: Blood samplesBiological: Biopsy

subjects Localised sclerosis diagnosed

EXPERIMENTAL
Biological: Blood samplesBiological: Biopsy

subjects Sc

EXPERIMENTAL
Biological: Blood samples

Interventions

Blood samplesBIOLOGICAL

* biological features of the standard follow-up * 2 more blood tube for the biological collection (serum and PBMC)

subjects Localised sclerosis diagnosedsubjects SSc diagnosedsubjects Sc
BiopsyBIOLOGICAL

Skin biopsies

subjects Localised sclerosis diagnosedsubjects SSc diagnosed

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age from 18 to 75.
  • SSc diagnosed according to the American College of Rheumatology (ACR) criteria.
  • With skin manifestations since less than 10 years.
  • Localised sclerosis (LSc) diagnosed, morphea type.

You may not qualify if:

  • Age inferior to 18 or upper than 75.
  • Skin manifestations since more than 10 years.
  • Haemostasis diseases (independent from treatments).
  • Stem cell transplant.
  • Immunosuppressive treatments in the last 6 months.
  • Associate autoimmune disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Rhumatologie - Tripode - Hôpital Pellegrin

Bordeaux, Bordeaux, 33076, France

Location

MeSH Terms

Conditions

Scleroderma, Systemic

Interventions

Blood Specimen CollectionBiopsy

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesCytodiagnosisCytological TechniquesDiagnostic Techniques, Surgical

Study Officials

  • Marie-Elise TRUCHETET, MD

    University Hospital Bordeaux, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 29, 2014

First Posted

September 29, 2015

Study Start

March 1, 2012

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

April 7, 2017

Record last verified: 2017-04

Locations

FR(1)