Institutional Review Board, Hospital for Special Surgery
January 23, 2015
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.
The RA Biodam Study is an observational study for patients with rheumatoid arthritis who have not taken biologics and are undergoing a change or increase in therapy. Patients will be followed clinically under normal standard of care. Blood and urine samples will be collected in addition to radiographs of the hands and feet. Patients are seen every 3 months for 2 years.
The study objective is to determine the independent predictive validity of several soluble biomarkers that are considered to be high priority candidates for predicting structural damage in RA. Identification of soluble biomarkers that are predictive of radiographic progression would be extremely valuable to both clinical research and clinical practice for a number of reasons. One reason is that it would allow for the identification of patients in clinical practice at high risk for disease progression and therefore requiring aggressive intervention early in the disease course.
This is a multi-center, multi-national study. Five patients will be enrolled at Hospital for Special Surgery. The enrollment period will be open until the overall U.S. enrollment target is collectively met by the U.S. sites.
• 18 years of age or older
• RA according to the 2010 Rheumatoid Arthritis Classification Criteria
• Joint symptoms for ≥ 3 months prior to screening
• DAS44 > 2.4
• About to start DMARD therapy (methotrexate, salazopyrin, hydroxychloroquine, chloroquine, leflunomide) or
o Increased dose of methotrexate by ≥ 5 mg weekly to a maximum dose of 25 mg weekly
o Add-on of alternative DMARD
o Switch to alternative DMARD
o Start of first anti-TNFα agent (adalimumab, etanercept, infliximab, certolizumab pegol, golimumab)
• Intra-articular steroid injection within 4 weeks prior to baseline visit
• Prior treatment with anti-TNFα or other biological agent
• Concurrent pregnancy or breast-feeding; wishes to conceive during the study period, or inadequate contraception
• Patient is not willing to sign an informed consent
• Non-English speaking