Metabolome Analysis in Patients With Rheumatoid Arthritis | NCT02960958

Studies
Metabolome Analysis in Patients With Rheumatoid Arthritis

NCT02960958

Sponsor

The Catholic University of Korea

Status

Unknown status

Last Update Posted

Jan 25, 2018Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

RheumatoId Arthritis

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 20, 2016Actual

Primary Completion Date

Oct 2018Estimated

Completion Date

Oct 2019Estimated

First Submitted Date

Nov 8, 2016

First Submission Date that Met QC Criteria

Nov 8, 2016

First Posted Date

Nov 10, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 23, 2018

Last Update Posted Date

Jan 25, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

200Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult patients with rheumatoid arthritis and healthy individuals

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jung Hee Koh, MD	Seoul St.Mary's hospital, The Catholic university of Korea	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001172	Arthritis, Rheumatoid

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided