Metabolome Analysis in Patients With Rheumatoid Arthritis

January 23, 2018 updated by: Jung Hee Koh, The Catholic University of Korea
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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult patients with rheumatoid arthritis and healthy individuals

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metabolic fingerprint of rheumatoid arthritis
Time Frame: 1 years
Metabolomic analyses of urine from patients with rheumatoid arthritis, healthy controls and other autoimmune disease
1 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlations between specific metabolites and disease activity/severity of RA
Time Frame: 1 year
Identified metabolites and their clinical significances
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Catholic University of Korea

Investigators

  • Principal Investigator: Jung Hee Koh, MD, Seoul St.Mary's hospital, The Catholic university of Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2016

Primary Completion (Anticipated)

October 1, 2018

Study Completion (Anticipated)

October 1, 2019

Study Registration Dates

First Submitted

November 8, 2016

First Submitted That Met QC Criteria

November 8, 2016

First Posted (Estimate)

November 10, 2016

Study Record Updates

Last Update Posted (Actual)

January 25, 2018

Last Update Submitted That Met QC Criteria

January 23, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CiRAD1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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