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Observational Multicenter Case-control Study to Assess Nailfold Capillary Abnormalities in Systemic Lupus Erythematosus

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ClinicalTrials.gov Identifier: NCT02801812
Recruitment Status : Unknown
Verified August 2017 by Ingegnoli Francesca, ASST Gaetano Pini-CTO.
Recruitment status was:  Enrolling by invitation
First Posted : June 16, 2016
Last Update Posted : August 9, 2017
Sponsor:
Collaborator:
EULAR study group on microcirculation in rheumatic diseases
Information provided by (Responsible Party):
Ingegnoli Francesca, ASST Gaetano Pini-CTO

Brief Summary:

The purpose of this study is to investigate the role of nailfold capillaroscopy in the assessment of patients with Systemic Lupus Erythematosus (SLE).

Primary endpoint:

- To compare the frequency of major capillaroscopic abnormalities in patients with SLE and healthy controls.

Secondary endpoints:

  • To compare the frequency of major capillaroscopic abnormalities in patients with active and non-active SLE / active SLE and healthy controls / non-active SLE and healthy controls.
  • To study the association of different capillaroscopic parameters and the status of subjects (SLE / active SLE / non-active SLE / healthy controls).

Condition or disease Intervention/treatment
Systemic Lupus Erythematosus Device: nailfold capillaroscopy

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 364 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: An Observational Multicenter International Case-control Study for the Assessment of Nailfold Capillary Abnormalities in Patients With Systemic Lupus Erythematosus
Study Start Date : January 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Group/Cohort Intervention/treatment
Systemic Lupus Erythematosus
patients ≥18 years diagnosed SLE upon classification according to 2012 SLICC criteria and disease onset ≥16 years.
Device: nailfold capillaroscopy
Detection by nailfold capillaroscopy of capillary abnormalities in patients with Systemic Lupus Erythematosus and comparison with healthy controls at enrolment

Healthy controls
subjects ≥18 years fulfilling the definition proposed in the protocol.
Device: nailfold capillaroscopy
Detection by nailfold capillaroscopy of capillary abnormalities in patients with Systemic Lupus Erythematosus and comparison with healthy controls at enrolment




Primary Outcome Measures :
  1. major capillary abnormalities [ Time Frame: Day 1 ]
    To compare the frequency of major capillary abnormalities in patients with SLE and healthy controls.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients ≥18 years diagnosed with SLE upon classification according to 2012 SLICC criteria and disease onset ≥16 years.
Criteria

Inclusion Criteria:

  • At time of enrollment all subjects must be 18 years or older and give written consent.
  • Patients with SLE must fulfill the 2012 SLICC classification criteria.
  • SLE onset must be over 16 years of age.
  • Patients with SLE and secondary anti-phospholipid syndrome will be also enrolled.
  • Healthy controls will be selected according to the definition proposed in the protocol

Exclusion Criteria:

  • Subject refuses to sign and/or he/she is not able to understand the patient informed consent.
  • Subjects with periungual traumatic lesions that may create artifacts (i.e. recent manicure, onychophagia, or gardening).
  • SLE overlapping with other rheumatic diseases such as Systemic Sclerosis, Rheumatoid Arthritis, Mixed Connective Tissue Disease, Sjögren's Syndrome, Dermatomyositis, Polymyositis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02801812


Sponsors and Collaborators
ASST Gaetano Pini-CTO
EULAR study group on microcirculation in rheumatic diseases
Investigators
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Principal Investigator: Francesca Ingegnoli, MD ASST Gaetano Pini-CTO

Publications:
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Responsible Party: Ingegnoli Francesca, MD, PhD, ASST Gaetano Pini-CTO
ClinicalTrials.gov Identifier: NCT02801812     History of Changes
Other Study ID Numbers: SG_MC/RD4
First Posted: June 16, 2016    Key Record Dates
Last Update Posted: August 9, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Ingegnoli Francesca, ASST Gaetano Pini-CTO:
Nailfold Capillaroscopy
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases