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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02051114
Other study ID # DOR-0833
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date February 2014
Est. completion date February 2025

Study information

Verified date April 2024
Source Rockefeller University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Longitudinal study of patients with rheumatoid arthritis comparing measures of disease activity with blood samples.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 25
Est. completion date February 2025
Est. primary completion date February 2025
Accepts healthy volunteers No
Gender Female
Age group 40 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States The Rockefeller University Hospital New York New York

Sponsors (1)

Lead Sponsor Collaborator
Rockefeller University

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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