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Consortium of Early Arthritis Cohorts USA (CATCH-US)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02386527
Recruitment Status : Recruiting
First Posted : March 12, 2015
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

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.


Condition or disease
Rheumatoid Arthritis

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2400 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Consortium of Early Arthritis Cohorts USA - A Prospective Cohort Study of Adults With New Consent Inflammatory Arthritis Symptoms to Understand Predictors of Optimal Outcomes
Study Start Date : December 2014
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arthritis




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]

Biospecimen Retention:   Samples With DNA
Maximum of 7 tubes of blood will be collected


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02386527


Locations
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United States, New York
Hospital for Special Surgery Recruiting
New York, New York, United States, 10021
Contact: Caroline E Reidy, MPH    646-714-6307    reidyc@hss.edu   
Principal Investigator: Vivian P Bykerk, MD         
Sub-Investigator: Susan M Goodman, MD         
Sub-Investigator: Dalit Ashany, MD         
Sponsors and Collaborators
Hospital for Special Surgery, New York
Additional Information:

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Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT02386527    
Other Study ID Numbers: 2014-229
First Posted: March 12, 2015    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Additional relevant MeSH terms:
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Arthritis
Joint Diseases
Musculoskeletal Diseases