A Study of the Biological Characteristics of Lupus
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: 15-008117
Sponsor Protocol Number: 15-008117
About this study
The purpose of this study is to understand the characteristics associated with lupus, to assist the early development of new treatments for human lupus and Sjögren's syndrome.
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.
Potential Participants with Systemic lupus erythematosus (SLE)
Inclusions Criteria
- Meets definition of SLE diagnosis
- Age 18-70
- Meets 4 or more ACR formal diagnostic criteria
- Anti-dsDNA positive
Exclusion Criteria
- Age <18
- Has chronic infectious disease
- Has cancer and is on chemotherapy
- CNS lupus
- Drug-induced lupus
- Is on IV steroids or cyclophosphamide
- Pregnant
Potential Participants with Sjogren’s Syndrome (SjS)
Inclusions Criteria
- Age 18-70
- Meets American-European Consensus Group classification for primary Sjogren’s Syndrome
- Previously established diagnosis of SjS and no other autoimmune connective tissue disease
- Positive dry eye signs and symptoms, subjective dry mouth symptoms
- Positive test for anti-Ro/SSA and/or anti-La/SSB
Exclusion Criteria
- Age <18
- Has chronic infectious disease,
- Has cancer and on chemotherapy
- Is on IV steroids or cyclophosphamide
- Pregnant
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 Mark Jensen, Ph.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available