Observational Multicenter Case-control Study to Assess Nailfold Capillary Abnormalities in Systemic Lupus Erythematosus
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 16-005985
NCT ID: NCT02801812
Sponsor Protocol Number: SG_MC/RD4
About this study
The purpose of this study is to investigate the role of nailfold capillaroscopy in the assessment of patients with Systemic Lupus Erythematosus (SLE).
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Ashima Makol, M.B.B.S. |
Closed for enrollment |
|
More information
Publications
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The Systemic Lupus International Collaborating Clinics (SLICC) group revised and validated the American College of Rheumatology (ACR) systemic lupus erythematosus (SLE) classification criteria in order to improve clinical relevance, meet stringent methodology requirements, and incorporate new knowledge regarding the immunology of SLE.
Read More on PubMed
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To describe the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K), a modification of SLEDAI to reflect persistent, active disease in those descriptors that had previously only considered new or recurrent occurrences, and to validate SLEDAI-2K against the original SLEDAI as a predictor for mortality and as a measure of global disease activity in the clinic.
Read More on PubMed