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Metabolome Analysis in Patients With Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02960958
Recruitment Status : Unknown
Verified January 2018 by Jung Hee Koh, The Catholic University of Korea.
Recruitment status was:  Enrolling by invitation
First Posted : November 10, 2016
Last Update Posted : January 25, 2018
Sponsor:
Information provided by (Responsible Party):
Jung Hee Koh, The Catholic University of Korea

Study Description
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Brief Summary:
The aim of this study is to investigate discriminant metabolites in urine from patients with rheumatoid arthritis (RA) from healthy individuals. Then we determine if the patient's metabolic fingerprint could predict the development or flare-up of RA.

Condition or disease
RheumatoId Arthritis

Detailed Description:

Compare metabolites between RA patients and healthy individuals.

  1. Collection urine sample
  2. Assessing urine metabolites by 1H NMR spectroscopy
  3. Analyzing the relationships between metabolites and clinical variables
Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Year
Official Title: Metabolome Analysis in Patients With Rheumatoid Arthritis
Actual Study Start Date : November 20, 2016
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Metabolic fingerprint of rheumatoid arthritis [ Time Frame: 1 years ]
    Metabolomic analyses of urine from patients with rheumatoid arthritis, healthy controls and other autoimmune disease


Secondary Outcome Measures :
  1. Correlations between specific metabolites and disease activity/severity of RA [ Time Frame: 1 year ]
    Identified metabolites and their clinical significances


Biospecimen Retention:   Samples Without DNA
Urine

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Adult patients with rheumatoid arthritis and healthy individuals
Criteria

Inclusion Criteria:

  • All patients with rheumatoid arthritis meet 2010 American College of Rheumatology/European League against Rheumatism classification criteria.

Exclusion Criteria:

  • Comorbid with other autoimmune diseases
  • Confirmed with amyloidosis
  • Chronic kidney disease (estimated GFR < 60 ml/min/1.73m2)
  • Chronic liver disease
  • Thyroid disease
  • Pregnancy
  • Solid tumor/hematologic malignancy within 5 years
Contacts and Locations
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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): NCT02960958


Sponsors and Collaborators
The Catholic University of Korea
Investigators
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Principal Investigator: Jung Hee Koh, MD Seoul St.Mary's hospital, The Catholic university of Korea
More Information
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Additional Information:

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Responsible Party: Jung Hee Koh, MD, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT02960958    
Other Study ID Numbers: CiRAD1
First Posted: November 10, 2016    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jung Hee Koh, The Catholic University of Korea:
Rheumatoid arthritis
Metabolomics
urine
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases