Discovering the Antecedents of Rheumatoid Arthritis Flare

Rheumatoid Arthritis Clinical Trial

Official title:

Discovering the Antecedents of Rheumatoid Arthritis Flare

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02051114
• Other study ID #: DOR-0833
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

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