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

Systemic Lupus Erythematosus Clinical Trial

Official title:

An Observational Multicenter International Case-control Study for the Assessment of Nailfold Capillary Abnormalities in Patients With Systemic Lupus Erythematosus

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02801812
• Other study ID #: SG_MC/RD4
• Status: Enrolling by invitation
• Phase: N/A
• First received: June 13, 2016
• Last updated: August 8, 2017
• Start date: January 2016
• Est. completion date: June 2018

Study information

• Verified date: August 2017
• Source: ASST Gaetano Pini-CTO
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Description:

Background and rationale:

Nailfold capillaroscopy (NC) is a diagnostic investigation used in the routine clinical setting for the differential diagnosis of connective tissue diseases, such as Systemic Lupus Erythematosus (SLE). Among SLE clinical manifestations, vascular involvement is a common feature and a variable prevalence of NC abnormalities has been reported in SLE: typical NC changes, as well as non-specific variations as observed in healthy subjects.

At this very moment literature is interspersed with different descriptions of capillaroscopic features in SLE, and it has not been clearly defined the role of NC in SLE patients. It has been suggested that the presence of major capillary abnormalities may reflect the microvascular systemic involvement in SLE, and it may correlate to the disease activity.

Against this background, the EULAR study group on microcirculation in rheumatic diseases planned an international multicenter study.

Objective:

To investigate the role of NC abnormalities in the assessment of SLE patients.

Endpoints:

Primary endpoint:

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

Secondary endpoints:

• To compare the frequency of major capillary 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 capillary parameters and the status of subjects (SLE / active SLE / non-active SLE / healthy controls).

No. of subjects:

Total entered: 364 ; Cases (SLE): 182 ; Controls: 182.

Variables

NC assessment: presence of major capillary abnormalities; NC parameters/mm: number of capillaries, presence of hairpin, tortuous, crossed, bushy, ramified, enlarged, giant capillaries, microhemorrhages, architecture disorganization, visibility of the subpapillary venular plexus; presence of scleroderma patterns, normal patterns.

Clinical assessment: all subjects: date of birth, gender, race. SLE: age at disease onset, disease activity (SLEDAI-2000) and damage index (SLICC-DI), presence of antinuclear antibodies, anti-dsDNA, anti-Extractable Nuclear Antigen antibodies, lupus anticoagulant, anticardiolipin/beta2glycoprotein I antibodies, Raynaud's phenomenon, Hypertension, active smoke, diabetes mellitus, ongoing and cumulative dose steroid treatment, ongoing immunomodulatory/suppressive treatment.

Statistical methods For the primary endpoint and similar secondary endpoints, McNemar test (matching design) and a conditional odds ratio (OR). For other secondary endpoints, the Fisher's exact test and an OR, and a conditional logistic regression model (matching design) and non-conditional regression model and OR as appropriate.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 364
• Est. completion date: June 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
ASST Gaetano Pini-CTO	EULAR study group on microcirculation in rheumatic diseases

References & Publications (2)

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

Petri M, Orbai AM, Alarcón GS, Gordon C, Merrill JT, Fortin PR, Bruce IN, Isenberg D, Wallace DJ, Nived O, Sturfelt G, Ramsey-Goldman R, Bae SC, Hanly JG, Sánchez-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	major capillary abnormalities	To compare the frequency of major capillary abnormalities in patients with SLE and healthy controls.	Day 1