- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02960958
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.
- Collection urine sample
- Assessing urine metabolites by 1H NMR spectroscopy
- 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
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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