Institutional Review Board, Hospital for Special Surgery
November 28, 2016
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.
Vivian P. Bykerk, MD
CATCH-US is an observational study of usual care for patients identified as “early rheumatoid arthritis”. We are looking at clinical variables typically collected as part of good clinical practice; labs, radiographs and other invasive tests will be recorded only if they are done as standard of care. This is a prospective cohort of all eligible and consenting patients referred to the Division of Rheumatology, the Inflammatory Arthritis Center and/or the Early Arthritis Program at HSS.
In order to study the effectiveness of recommended treatments in usual practice in different patients for short-term and long-term outcomes, and to determine factors that may predict how a patient’s disease might progress over time, we need to understand:
i. the frequency of single time-point and sustained (two or more time points) remission over time and factors that influence remission
ii. which patients can achieve persistent remission, and
iii. who can undergo drug withdrawal.
Thirty five (35) patients with new onset synovitis consistent with rheumatoid arthritis will be enrolled and assessed at their baseline visit and seen every three months for the first year. Thereafter patients will be seen every six months. We will analyze and describe the strategies used to manage these patients over a 1 year period with optional 2 year follow up.
This is a single-site study that will be expanded into a multicenter study at 6-8 other U.S. sites over 12-18 months. These data are being gathered to provide the rationale for further clinical studies to determine which variables best reveal the effectiveness of various treatments for real world ERA patients over time.
• Age > 18 years at time of referral, and
• Joint symptoms for ≤12 months, and
• At least one of the following:
two (2) or more swollen joints
one (1) swollen metacarpophalangeal (MCP) or proximal interphalangeal (PIP) joint and any one (or more) of the following:
• (+) Rheumatoid Factor (RF), (+) anti-CCP antibody (anti cyclic Citrullinated peptide antibody), morning (am) stiffness ≥ 45 minutes, Response to NSAID, (+) metatarsophalangeal joint (MTP) squeeze test
• Active synovitis thought to be related to hepatitis C
• Patients who have features of other autoimmune diseases that could cause doubt that the patient has probable or definite RA, in the opinion of the investigator.
• Pregnant or nursing.
• Unable to give informed consent.
• Lack of fluency in English. Unfortunately, we do not have the financial resources to offer full translation services.
• Unwilling or unable to be followed as part of routine care.