Clinical trial NCT02051114: Discovering the Antecedents of Rheumatoid Arthritis Flare
Official title: Discovering the Antecedents of Rheumatoid Arthritis Flare
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid arthritis
Lead sponsor: Rockefeller University
Sponsor class: OTHER
First posted: 2014-01-31
Enrollment: 25
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Rheumatoid Arthritis

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: RNA transcripts that correlate with rheumatoid arthritis disease activity
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: The Rockefeller University Hospital
state: New York
Study officials:
affiliation: The Rockefeller University Hospital
name: Dana E Orange, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.