- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02051114
Discovering the Antecedents of Rheumatoid Arthritis Flare
April 15, 2026 updated by: Rockefeller University
Longitudinal study of patients with rheumatoid arthritis comparing measures of disease activity with blood samples.
Study Overview
Status
Active, not recruiting
Conditions
Detailed Description
80% of patients living with rheumatoid arthritis can expect fluctuations in their symptoms over time.
Dramatic increases in disease activity are considered flare.
This study will follow patients with increased risk for flare prospectively for one year.
Serial questionnaires and disease activity scores will be compared to blood samples to better understand the molecular phenotype of rheumatoid arthritis flares.
Study Type
Observational
Enrollment (Estimated)
25
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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New York, New York, United States, 10065
- The Rockefeller University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Rheumatoid Arthritis
Description
Inclusion Criteria:
- 2010 criteria for Rheumatoid Arthritis
- Swelling of at least one joint and or elevated acute phase reactants
- Greater than or equal to 40 years old or less than or equal to 65 year old female sex
- cyclic citrullinated peptide antibody + in the past 12 months
Exclusion Criteria:
- hemoglobin < 9
- white blood cell count < 3.5
- Diagnosis of any active malignancy within the last 3 years besides non-melanomatous skin cancer
- Diagnosis of diabetes and requires insulin
- HIV+, Hep B S Ag+, Hep C polymerase chain reaction +
- Untreated latent tuberculosis
- Diagnosis of any additional systemic autoimmune connective tissue disease
- Inability to reliably complete study requirements
- History, physical, social or laboratory findings suggestive of any other medical or psychological condition that would, in the opinion of the principal investigator, make the candidate ineligible for the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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RNA transcripts that correlate with rheumatoid arthritis disease activity
Time Frame: 1 year
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Blood drawn at various times throughout one year will be correlated with fluctuations in RA disease activity.
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1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dana E Orange, MD, MS, The Rockefeller University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Orange DE, Yao V, Sawicka K, Fak J, Frank MO, Parveen S, Blachere NE, Hale C, Zhang F, Raychaudhuri S, Troyanskaya OG, Darnell RB. RNA Identification of PRIME Cells Predicting Rheumatoid Arthritis Flares. N Engl J Med. 2020 Jul 16;383(3):218-228. doi: 10.1056/NEJMoa2004114.
- Brewer RC, Lanz TV, Hale CR, Sepich-Poore GD, Martino C, Swafford AD, Carroll TS, Kongpachith S, Blum LK, Elliott SE, Blachere NE, Parveen S, Fak J, Yao V, Troyanskaya O, Frank MO, Bloom MS, Jahanbani S, Gomez AM, Iyer R, Ramadoss NS, Sharpe O, Chandrasekaran S, Kelmenson LB, Wang Q, Wong H, Torres HL, Wiesen M, Graves DT, Deane KD, Holers VM, Knight R, Darnell RB, Robinson WH, Orange DE. Oral mucosal breaks trigger anti-citrullinated bacterial and human protein antibody responses in rheumatoid arthritis. Sci Transl Med. 2023 Feb 22;15(684):eabq8476. doi: 10.1126/scitranslmed.abq8476. Epub 2023 Feb 22.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2014
Primary Completion (Estimated)
February 1, 2030
Study Completion (Estimated)
February 1, 2030
Study Registration Dates
First Submitted
January 29, 2014
First Submitted That Met QC Criteria
January 29, 2014
First Posted (Estimated)
January 31, 2014
Study Record Updates
Last Update Posted (Actual)
April 16, 2026
Last Update Submitted That Met QC Criteria
April 15, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DOR-0833
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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