Complement Activation Signatures and Treatment 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: 14-010007
Sponsor Protocol Number: 14-010007
About this study
The purpose of this study to look at certain blood proteins known as complement proteins in the whole blood of patients with systemic lupus erythematosus (SLE or lupus). We propose that the levels of these proteins will A) predict lupus disease activity, B) provide information regarding efficacy of treatment, and c) provide SLE diagnostic information.
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:
Subjects who are recruited to the study will donate blood. We will try to obtain this sample during a previously scheduled blood draw to minimize the number of needle sticks. However, we may draw blood solely for research purposes when necessary. Details of sample collection for newly recruited subjects are described below:
- Subjects will be enrolled in either an outpatient or inpatient setting:
Outpatients:
- Subjects may be enrolled in Rheumatology by trained interviewers (study staff), and blood may be drawn at the next visit for which they are scheduled to have blood drawn.The interviewer will explain what participation entails.
- Participants will be asked to sign a written consent form that will allow us to conduct research to identify markers that predict health and disease status and disease progression.
- Results of “c” will be obtained from the patient’s chart. Participants will donate blood (finger sticks or venipuncture) as clinically warranted for a period of 1 year. Some participants may have 1 visit and some may have 4 visits but these will be determined by the treating physician. All subjects will initially donate 4 mL of blood at the same time of obtaining consent (if the patient has not yet had a blood sample collected), or at the next scheduled phlebotomy appointment for blood collections. Participants may be asked to donate more blood in the future, if it is deemed clinically necessary. At the re-draws, a total of 4 mL blood will be drawn.See details below.
- Participants will be asked questions about their medical history, medication history, and demographics, and
- Physical examination
Inpatients:
- Patients will be enrolled during their inpatient stay and will have samples drawn during a scheduled blood draw whenever possible.
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 Timothy Niewold, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available