CPMC Early Undifferentiated Arthritis Registry

NCT02353221 | Completed

• 1 other identifier: GRO
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

The CPMC early arthritis registry will recruit participants from a population of new patients undergoing evaluation at the office of participating physicians. Patients enrolled in the registry will undergo longitudinal observation and sampling. The investigators will collect questionnaire data and create a biological sample repository. The information obtained will be use to generate hypotheses aimed at explaining how environmental and genetic factors are interrelated to influence UA disease outcomes. Analysis will be performed on the patient's data and biological samples in order to; A. Assess the epidemiological and clinical characteristics of patients with early arthritis in the referral pool at CPMC. B. Analyze the phenotype and genotype of peripheral blood mononuclear cells (PBMC) from individual patients based on their chemokine/cytokine secretion, cell adhesion molecule expression, gene expression, DNA methylation and non coding RNA profiles. C. Generate hypothesis aimed to identify clinical criteria and novel biomarkers to be used in the diagnosis, prognosis, and therapeutic decisions for patients with early UA

Conditions

Early Undifferentiated Arthritis

Keywords

Early arthritis; undiferentiated arthritis

Outcome Measures

Primary Outcomes (1)

• Diagnosis of inflammatory arthritis

  one year

Study Arms (2)

Subjects

Entry criteria include being at least 18 years old at screening visit, being able to understand the information given to them and to give written informed consent, willingness to comply with the requirements of the data collection, absence of a diagnose of autoimmune disease or inflammatory arthritis, and absence of a previous treatment with any disease modifying anti-rheumatic drug (DMARD). We will exclude patients that are pregnant or intend to become pregnant during the time of follow up.

Controls

Healthy control subjects will be recruited based on similar criteria as study subjects. Our effort will be to include age and gender matched control subjects in the registry. We will be also aiming to match environmental characteristics (i.e. partners living in same location as registry subject or in a radius of 10 miles for at least one year previous to the date of evaluation) or genetic background (i.e. by asking the participation of first-degree relatives)

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants: Any patient undergoing evaluation for arthritis will be considered eligible. The pool of potential subjects will include any patient presenting to the office of participating physicians for evaluation of arthritis.

You may qualify if:

• Entry criteria include being at least 18 years old at screening visit
• Being able to understand the information given to them and to give written informed consent
• Willingness to comply with the requirements of the data collection
• Absence of a diagnose of autoimmune disease or inflammatory arthritis
• Absence of a previous treatment with any disease modifying anti-rheumatic drug (DMARD)

You may not qualify if:

• We will exclude patients that are pregnant or intend to become pregnant during the time of follow up.

Sponsors & Collaborators

• California Pacific Medical Center Research Institute: lead

Study Sites (1)

California Pacific Medical Center

San Francisco, California, 94115, United States

Location

Related Publications (1)

• 1. Hitchon CA, Peschken CA, Shaikh S, El-Gabalawy HS. Early undifferentiated arthritis. Rheum Dis Clin North Am 2005;31:605-26. 2. Kremer JM, Gibofsky A, Greenberg JD. The role of drug and disease registries in rheumatic disease epidemiology. Curr Opin Rheumatol 2008;20:123-30. 3. Pincus T. Limitations of randomized clinical trials in chronic diseases: explanations and recommendations. Adv Mind Body Med 2002;18:14-21. 4. Goekoop-Ruiterman YP, de Vries-Bouwstra JK, Allaart CF, et al. Clinical and radiographic outcomes of four different treatment strategies in patients with early rheumatoid arthritis (the BeSt study): a randomized, controlled trial. Arthritis Rheum 2005;52:3381-90. 5. Lard LR, Visser H, Speyer I, et al. Early versus delayed treatment in patients with recent-onset rheumatoid arthritis: comparison of two cohorts who received different treatment strategies. Am J Med 2001;111:446-51. 6. Lillegraven S, Kvien TK. Measuring disability and quality of life in established rheumatoid arthritis. Best Pract Res Clin Rheumatol 2007;21:827-40. 7. Yeboah J, Redline S, Johnson C, et al. Association between sleep apnea, snoring, incident cardiovascular events and all-cause mortality in an adult population: MESA. Atherosclerosis 2011;219:963-8. 8. Willett WC, Sampson L, Stampfer MJ, et al. Reproducibility and validity of a semiquantitative food frequency questionnaire. American journal of epidemiology 1985;122:51-65.

  BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples: Our objective is to create a repository that includes PBMCs and serum samples suitable for functional assays as well as nucleic acid analysis. These efforts will make our cohort a unique source to measure PBMC antigen-specific proliferation, cytokine and chemokine secretion, and activation markers expression among others. Blood will be fractionated for serum analysis and cell analysis. PBMCs will be sorted into neutrophils, B cells, T cells, and monocytes. Cells will be used for RNA and DNA extraction and analysis, for functional assays involving cytokine and chemokine production, cell proliferation, and expression of surface markers of activation.

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Pedro J. Ruiz, MD PhD

  CPMCRI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Rheumatologist

Study Record Dates

• First Submitted: January 28, 2015
• First Posted: February 2, 2015
• Study Start: January 1, 2015
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: March 9, 2022

Record last verified: 2022-03

Locations

US (1)