Metabolome Analysis in Patients With Rheumatoid Arthritis

RheumatoId Arthritis Clinical Trial

Official title:

Metabolome Analysis in Patients With Rheumatoid Arthritis

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02960958
• Other study ID #: CiRAD1
• Status: Enrolling by invitation
• Phase: N/A
• First received: November 8, 2016
• Last updated: January 23, 2018
• Start date: November 20, 2016
• Est. completion date: October 2019

Study information

• Verified date: January 2018
• Source: The Catholic University of Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: October 2019
• Est. primary completion date: October 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• RheumatoId Arthritis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Catholic University of Korea

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolic fingerprint of rheumatoid arthritis	Metabolomic analyses of urine from patients with rheumatoid arthritis, healthy controls and other autoimmune disease	1 years
Secondary	Correlations between specific metabolites and disease activity/severity of RA	Identified metabolites and their clinical significances	1 year