An observational study in Rheumatoid Arthritis, sponsored by Hospital for Special Surgery, New York. Terminated at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-13.
Sponsored by Hospital for Special Surgery, New York · Observational
Rheumatoid arthritis (RA) is the most common form of inflammatory arthritis. In the US, it is estimated that as many as 3 million adults may suffer from the disease. Fortunately in the last few years, a shift in strategy toward the earlier institution of disease modifying drugs and the availability of new classes of medications have greatly improved the outcomes that can be expected by most patients.
The goal of treatment now aims toward achieving the lowest possible level of arthritis disease activity and even remission, if possible as early on as possible. Research has shown that this translates into minimized joint damage and enhanced physical function and quality of life for the RA patient. This also requires that a diagnosis of RA be made as early on as possible, and herein lies the challenge, i.e. identifying the RA patient early on in the course of their disease.
This is a study of usual care, a prospective cohort of all eligible and consenting patients referred to the Inflammatory Arthritis Center of Excellence and the Division of Rheumatology, Department of Medicine at HSS as well as 3 consortium sites across the U.S.
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, investigators will need to analyze and describe the strategies used to manage these patients and will need to understand:
i. The frequency of single time-point and sustained (two or more time points) remission or low disease activity over time ii. Factors that influence remission iii. Which patients can achieve persistent sustained remission, and iv. Who can undergo drug withdrawal and still sustain remission of low disease activity v. Factors associated with treatment optimization or barriers to achieving this
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 119 is below the median of 155 across 1,057 observational studies indexed under Arthritis.
Browse Arthritis studies →Hospital for Special Surgery, New York is the lead sponsor of 217 studies on the registry; 39 are open to participants now.
Of its 27 completed or terminated interventional studies of FDA-regulated products, 20 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Most patients will have been referred by their primary care providers (PCP) for an expedited assessment and all will have met inclusion criteria. If the patient is appropriate for inclusion into the cohort, the study will be explained to the patient by the rheumatologist or designate. If he/she is interested, the information sheet and consent form will be reviewed with the study nurse or coordinator and consent will be obtained. As this is a study of usual care, study data is the information collected during regular clinic visits. Therefore, the patient will be consenting to have the data from their regular assessments entered into the study database. A schedule of regular visits has been identified in advance in keeping with best clinical practice and management of ERA.
Inclusion Criteria:
Rapidity and sustainability of SDAI remission as achieved over a one year period
Time frame: 3 months, 6 months, 9 months and 12 months of follow-up
The proportion of patients achieving DAS28 remission and CDAI remission twice
Time frame: 3 months, 6 months, 9 months and 12 months of follow-up
Rapid radiographic progression, as measured by a van der Heijde Sharp Score change of 5 point or more
Time frame: 2 months and 24 months of follow-up
This study is terminated, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Hospital for Special Surgery, New York