Systemic Lupus ErythematosusNCT02801812
Observational Multicenter Case-control Study to Assess Nailfold Capillary Abnormalities in Systemic Lupus Erythematosus
An observational study of Systemic Lupus Erythematosus, run by ASST Gaetano Pini-CTO.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- nailfold capillaroscopy
- Type of treatment
- Medical device
- How many people
- 364 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients ≥18 years diagnosed with SLE upon classification according to 2012 SLICC criteria and disease onset ≥16 years.
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: An Observational Multicenter International Case-control Study for the Assessment of Nailfold Capillary Abnormalities in Patients with Systemic Lupus Erythematosus
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).
Read the detailed 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.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- nailfold capillaroscopy
- Keywords
- Nailfold Capillaroscopy
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nailfold capillaroscopyDevice
Detection by nailfold capillaroscopy of capillary abnormalities in patients with Systemic Lupus Erythematosus and comparison with healthy controls at enrolment
| Study group | Role | What they receive |
|---|---|---|
| Systemic Lupus Erythematosus | patients ≥18 years diagnosed SLE upon classification according to 2012 SLICC criteria and disease onset ≥16 years. Receives: Device: nailfold capillaroscopy | |
| Healthy controls | subjects ≥18 years fulfilling the definition proposed in the protocol. Receives: Device: nailfold capillaroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
major capillary abnormalities
To compare the frequency of major capillary abnormalities in patients with SLE and healthy controls.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2018
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 364 participants (actual)
Sponsor and investigators
- Lead sponsor
- ASST Gaetano Pini-CTO
- Sponsor type
- University, hospital or other
- Collaborators
- EULAR study group on microcirculation in rheumatic diseases
- Responsible party
- Principal investigator, Ingegnoli Francesca, ASST Gaetano Pini-CTO
- Investigators
- Francesca Ingegnoli, MD, Principal investigator, ASST Gaetano Pini-CTO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02801812
- Sponsor's protocol ID
- SG_MC/RD4
- Status last verified
- Mar 2025
- First submitted
- 13 Jun 2016
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 22553077Gladman DD, Ibanez D, Urowitz MB. Systemic lupus erythematosus disease activity index 2000. J Rheumatol. 2002 Feb;29(2):288-91.
PubMed 11838846Ingegnoli 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.
PubMed 40921627
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Multicenter International Case-control Study for the Assessment of Nailfold Capillary Abnormalities in Patients with Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT02801812
- Acronym / sponsor ID
- SG_MC/RD4
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Nailfold Capillaroscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 364 participants (actual)
- Lead sponsor
- ASST Gaetano Pini-CTOUniversity, hospital or other
- Collaborators
- EULAR study group on microcirculation in rheumatic diseases
- Study start
- Jan 2016
- Primary completion
- Dec 2018 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 16 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Systemic Lupus Erythematosus | – | Device: nailfold capillaroscopypatients ≥18 years diagnosed SLE upon classification according to 2012 SLICC criteria and disease onset ≥16 years. |
| Healthy controls | – | Device: nailfold capillaroscopysubjects ≥18 years fulfilling the definition proposed in the protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients ≥18 years diagnosed with SLE upon classification according to 2012 SLICC criteria and disease onset ≥16 years.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nailfold capillaroscopyDetection by nailfold capillaroscopy of capillary abnormalities in patients with Systemic Lupus Erythematosus and comparison with healthy controls at enrolment | Device | Healthy controls, Systemic Lupus Erythematosus |
Primary outcome
major capillary abnormalities
Time frame: Day 1
To compare the frequency of major capillary abnormalities in patients with SLE and healthy controls.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Background: PubMed 22553077Petri 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.
- Background: PubMed 11838846Gladman DD, Ibanez D, Urowitz MB. Systemic lupus erythematosus disease activity index 2000. J Rheumatol. 2002 Feb;29(2):288-91.
- Derived from this study: PubMed 40921627Ingegnoli 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesca Ingegnoli, MD principal investigator
ASST Gaetano Pini-CTO
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Lupus Erythematosus, run by ASST Gaetano Pini-CTO.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
major capillary abnormalities (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02801812, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.