Discovering the Antecedents of Rheumatoid Arthritis Flare
1 other identifier
observational
25
1 country
1
Brief Summary
Longitudinal study of patients with rheumatoid arthritis comparing measures of disease activity with blood samples.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2014
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2014
CompletedFirst Posted
Study publicly available on registry
January 31, 2014
CompletedStudy Start
First participant enrolled
February 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2030
April 16, 2026
April 1, 2026
16 years
January 29, 2014
April 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
RNA transcripts that correlate with rheumatoid arthritis disease activity
Blood drawn at various times throughout one year will be correlated with fluctuations in RA disease activity.
1 year
Eligibility Criteria
Rheumatoid Arthritis
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Rockefeller University Hospital
New York, New York, 10065, United States
Related Publications (2)
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.
PMID: 32668112BACKGROUNDBrewer 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.
PMID: 36812347BACKGROUND
Biospecimen
Blood samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dana E Orange, MD, MS
The Rockefeller University Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2014
First Posted
January 31, 2014
Study Start
February 1, 2014
Primary Completion (Estimated)
February 1, 2030
Study Completion (Estimated)
February 1, 2030
Last Updated
April 16, 2026
Record last verified: 2026-04