A Study to Perform Synovial Biopsies on Patients with Rheumatoid Arthritis
Overview
Tab Title Description
Study type
InterventionalDescribes 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: 14-003329
Sponsor Protocol Number: 14-003329
About this study
The purpose of this study is to get synovial tissue from patients with rheumatoid arthritis by minimally invasive ultrasound guided biopsy, for the purpose of identifying the processes that are responsible for the cause of the disease.
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
- Have a diagnosis of rheumatoid arthritis as defined by either the 1987 ARA or 2010 ACR/EULAR criteria
- data for both criteria will be recorded
- Must have been 18 years of age or older at the time of diagnosis of RA
- At least one joint swollen and thought to be due to active RA
- Joint should be amenable to minimally invasive ultrasound guided synovial tissue biopsy (MIUGSTB) including elbow, wrist, MCP, PIP, knee, ankle, or shoulder
- Screening laboratory tests must meet the following criteria
- Hemoglobin ≥ 9 g/dL
- Platelets ≥ 100 x 109 cells/L
- Able to adhere to the study visit schedule, understand and comply with other protocol requirements
- Capable of giving informed consent, which will be obtained prior to any screening procedures
- Control subjects must be arthritis-free
- Surgical osteoarthritis patients must have a clinical diagnosis of osteoarthritis and are undergoing a clinically directed surgical procedure
- Surgical rehumatoid arthritis patients must have a diagnosis of RA (as defined by the either 1987 ARA or 2010 ACR/EULAR criteria – data for both criteria will be recorded ) and are undergoing a clinically directed surgical procedure
- All subjects must have given signed, informed consent prior to registration on study
Exclusion Criteria
- Pregnant or lactating women
- Active infections such as hepatitis, pneumonia, pyelonephritis or chronic skin infections
- Current signs or symptoms of uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic or cerebral disease
- History of bleeding disorder
- History of infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
- Documented diagnosis of SLE or seronegative spondyloarthropathy
- Soft tissue, or intra-muscular corticosteroid injections during the 4 weeks prior to screening
- Corticosteroid injection into joint to be biopsied (within 8 weeks)
- Previous arthroplasty on the target joint
- Current use of warfarin, clopidogrel or other anticoagulant
- Prednisone or equivalent > 10 mg daily
- Exclusion criteria are the same for controls
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 Eric Matteson, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available