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CPMC Early Undifferentiated Arthritis Registry (CEUAR)

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ClinicalTrials.gov Identifier: NCT02353221
Recruitment Status : Recruiting
First Posted : February 2, 2015
Last Update Posted : January 25, 2018
Sponsor:
Information provided by (Responsible Party):
Pedro Ruiz, California Pacific Medical Center Research Institute

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


Condition or disease
Arthritis

  Show Detailed Description

Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: California Pacific Medical Center Early Undifferentiated Arthritis Registry
Study Start Date : January 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arthritis

Group/Cohort
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)



Primary Outcome Measures :
  1. Diagnosis of inflammatory arthritis [ Time Frame: one year ]

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.


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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02353221


Contacts
Contact: Pedro J Ruiz, MD PhD (415) 923-3060 ruizpj@sutterhealth.org
Contact: Elaine Y. Yan (415) 600 5743 YanEY@cpmcri.org

Locations
United States, California
California Pacific Medical Center Recruiting
San Francisco, California, United States, 94115
Sponsors and Collaborators
California Pacific Medical Center Research Institute
Investigators
Principal Investigator: Pedro J. Ruiz, MD PhD CPMCRI

Publications:
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.

Responsible Party: Pedro Ruiz, Rheumatologist, California Pacific Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT02353221     History of Changes
Other Study ID Numbers: GRO
First Posted: February 2, 2015    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018

Keywords provided by Pedro Ruiz, California Pacific Medical Center Research Institute:
Early arthritis
undiferentiated arthritis

Additional relevant MeSH terms:
Arthritis
Joint Diseases
Musculoskeletal Diseases