IRB Number: 2022-1201
Institutional Review Board, Hospital for Special Surgery
December 21, 2022
The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.
Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.
For further information, see Understanding Clinical Trials.
Theresa Wampler Muskardin, MD
Scott A. Rodeo, MD
Ogonna Kenechi Nwawka, MD
Timothy B. Niewold, MD, FACR
The purpose of this study is to better understand inflammatory arthritis and identify biological markers (cellular and genetic markers) that may help us predict if a specific treatment may or may not work for specific groups of patients with inflammatory arthritis.
This study aims to identify risk factors for developing inflammatory arthritis and identify different markers that could contribute to finding new therapeutic targets and treatments for Inflammatory arthritis. Your biological samples and corresponding data provided by you and gathered from your medical record will be used for the purpose of this study.
A total of 100 subjects will participate in this study at HSS.
- All patients will be required to participate in 1 baseline visit over the next 12 months.
- This visit will occur whenever you come in for routine care.
- If you are an Rheumatoid Arthritis/Inflammatory Arthritis patient there is an option to participate in 3 additional follow-up visits over the next 12 months. Your participation will last up to 5 years. You will not be asked to come into the hospital for research visits. All visits will be conducted during routine care. Each visit must be more than or equal to 3 months apart. You do not need to complete all 4 visits per year.
- Patients with osteoarthritis (OA) are also being asked to participate since you are an individual who does not have an autoimmune disease or inflammatory arthritis. Your biospecimen and biospecimen-derived information will be compared to those of patients with inflammatory arthritis to find potential differences
- Participants must be 18 years or Older
- Must be willing to provideconsent
- Participants must be willing to provide a blood sample
- Must have one of the following diagnoses:
- Rheumatoid Arthritis
- Probable diagnosis termed "pre-RA"
- Inflammatory Arthritis (other than RA)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- unable to provide written informed consent
- Has been diagnosed with a chronic infectious diseases
- Is receiving on-going treatment for, or current diagnosis of cancer
- Diagnosed or treated for any cancer in the past 3 years
- Is currently pregnant
- Has had a recent infection or currently infection in the last 2 weeks
Theresa Wampler Muskardin, MD