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

NCT02801812 | Completed

• 1 other identifier: SG_MC/RD4
• Study Type: observational
• Target: 364
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Systemic Lupus Erythematosus

Keywords

Nailfold Capillaroscopy

Outcome Measures

Primary Outcomes (1)

• major capillary abnormalities

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

  Day 1

Study Arms (2)

Systemic Lupus Erythematosus

patients ≥18 years diagnosed SLE upon classification according to 2012 SLICC criteria and disease onset ≥16 years.

Device: nailfold capillaroscopy

Healthy controls

subjects ≥18 years fulfilling the definition proposed in the protocol.

Device: nailfold capillaroscopy

Interventions

nailfold capillaroscopy DEVICE

Detection by nailfold capillaroscopy of capillary abnormalities in patients with Systemic Lupus Erythematosus and comparison with healthy controls at enrolment

Healthy controls; Systemic Lupus Erythematosus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ASST Gaetano Pini-CTO: lead
• EULAR study group on microcirculation in rheumatic diseases: collaborator

Related Publications (3)

• Petri M, Orbai AM, Alarcon GS, Gordon C, Merrill JT, Fortin PR, Bruce IN, Isenberg D, Wallace DJ, Nived O, Sturfelt G, Ramsey-Goldman R, Bae SC, Hanly JG, Sanchez-Guerrero J, Clarke A, Aranow C, Manzi S, Urowitz M, Gladman D, Kalunian K, Costner M, Werth VP, Zoma A, Bernatsky S, Ruiz-Irastorza G, Khamashta MA, Jacobsen S, Buyon JP, Maddison P, Dooley MA, van Vollenhoven RF, Ginzler E, Stoll T, Peschken C, Jorizzo JL, Callen JP, Lim SS, Fessler BJ, Inanc M, Kamen DL, Rahman A, Steinsson K, Franks AG Jr, Sigler L, Hameed S, Fang H, Pham N, Brey R, Weisman MH, McGwin G Jr, Magder LS. Derivation and validation of the Systemic Lupus International Collaborating Clinics classification criteria for systemic lupus erythematosus. Arthritis Rheum. 2012 Aug;64(8):2677-86. doi: 10.1002/art.34473.

  PMID: 22553077 BACKGROUND

• Gladman DD, Ibanez D, Urowitz MB. Systemic lupus erythematosus disease activity index 2000. J Rheumatol. 2002 Feb;29(2):288-91.

  PMID: 11838846 BACKGROUND

• Ingegnoli F, Ughi N, Riccieri V, Stefanantoni K, Cracowski JL, Gutierrez M, Sulli A, Rodriguez-Reyna TS, Hame A, Makol A, Nuno-Nuno L, Nieto-Gonzalez JC, Kubo S, Michalska-Jakubus M, Sanchez Pernaute O, De Angelis R, Herrick AL, Melsens K, Cutolo M, Smith V; EULAR Study Group on Microcirculation in Rheumatic Diseases collaborators. Distribution of nailfold videocapillaroscopy parameters in systemic lupus erythematosus and their association with disease activity: an international blinded case-control analysis on behalf of the EULAR study group on microcirculation in rheumatic diseases. RMD Open. 2025 Sep 8;11(3):e005772. doi: 10.1136/rmdopen-2025-005772.

  PMID: 40921627 DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

Microscopic Angioscopy

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Intravital Microscopy; Microscopy; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Cardiovascular; Investigative Techniques

Study Officials

• Francesca Ingegnoli, MD

  ASST Gaetano Pini-CTO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: June 13, 2016
• First Posted: June 16, 2016
• Study Start: January 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: February 1, 2019
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share