Consortium of Early Arthritis Cohorts USA

NCT02386527 | Terminated

• 1 other identifier: 2014-229
• Study Type: observational
• Target: 119
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Rapidity and sustainability of SDAI remission as achieved over a one year period

  3 months, 6 months, 9 months and 12 months of follow-up

Secondary Outcomes (2)

• The proportion of patients achieving DAS28 remission and CDAI remission twice

  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

  2 months and 24 months of follow-up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• Patient was 18 years of age or over at time of referral
• Joint symptoms for \< 12 months
• + swollen joints OR 1 swollen joint with one of the following: Rheumatoid Factor \> 20 IU, (+) anti-CCP antibody, morning stiffness \> 45 minutes, responded to NSAIDs, (+) MTP squeeze test

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead
• Northwestern University: collaborator
• Johns Hopkins University: collaborator

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Maximum of 7 tubes of blood will be collected

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 26, 2015
• First Posted: March 12, 2015
• Study Start: December 1, 2014
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: April 13, 2025

Record last verified: 2024-11

Locations

US (1)