NCT02960958

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2016

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 10, 2016

Completed
10 days until next milestone

Study Start

First participant enrolled

November 20, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

January 25, 2018

Status Verified

January 1, 2018

Enrollment Period

1.9 years

First QC Date

November 8, 2016

Last Update Submit

January 23, 2018

Conditions

RheumatoId Arthritis

Keywords

Rheumatoid arthritisMetabolomicsurine

Outcome Measures

Primary Outcomes (1)

  • Metabolic fingerprint of rheumatoid arthritis

    Metabolomic analyses of urine from patients with rheumatoid arthritis, healthy controls and other autoimmune disease

    1 years

Secondary Outcomes (1)

  • Correlations between specific metabolites and disease activity/severity of RA

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients with rheumatoid arthritis and healthy individuals

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Jung Hee Koh, MD

    Seoul St.Mary's hospital, The Catholic university of Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 8, 2016

First Posted

November 10, 2016

Study Start

November 20, 2016

Primary Completion

October 1, 2018

Study Completion

October 1, 2019

Last Updated

January 25, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share