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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02386527
Other study ID # 2014-229
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 2014
Est. completion date December 2023

Study information

Verified date August 2021
Source Hospital for Special Surgery, New York
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 2400
Est. completion date December 2023
Est. primary completion date June 13, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patient was 18 years of age or over at time of referral - Joint symptoms for < 12 months - 2+ 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Hospital for Special Surgery New York New York

Sponsors (1)

Lead Sponsor Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 The proportion of patients achieving DAS28 remission and CDAI remission twice 3 months, 6 months, 9 months and 12 months of follow-up
Secondary 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
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