RheumatoId ArthritisNCT02960958
Metabolome Analysis in Patients With Rheumatoid Arthritis
An observational study of RheumatoId Arthritis, run by The Catholic University of Korea.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- RheumatoId Arthritis
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 20 Nov 2016to Oct 2019
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients with rheumatoid arthritis and healthy individuals
Who may be able to join
- All patients with rheumatoid arthritis meet 2010 American College of Rheumatology/European League against Rheumatism classification criteria.
Who cannot join
- 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
About this study
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.
Read the 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
- Conditions
- RheumatoId Arthritis
- Keywords
- Rheumatoid arthritis, Metabolomics, urine
- Medical subject headings
- Arthritis, Rheumatoid
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic fingerprint of rheumatoid arthritis
Metabolomic analyses of urine from patients with rheumatoid arthritis, healthy controls and other autoimmune disease
Measured: 1 years
Secondary outcomes (1)
Correlations between specific metabolites and disease activity/severity of RA
Identified metabolites and their clinical significances
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2016 (estimated)
- Study start20 Nov 2016
- Primary completionOct 2018 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RheumatoId ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jung Hee Koh, The Catholic University of Korea
- Investigators
- Jung Hee Koh, MD, Principal investigator, Seoul St. Mary's Hospital, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02960958
- Sponsor's protocol ID
- CiRAD1
- Status last verified
- Jan 2018
- First submitted
- 8 Nov 2016
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolome Analysis in Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT02960958
- Acronym / sponsor ID
- CiRAD1
- Conditions
- RheumatoId Arthritis
- Keywords
- Rheumatoid arthritis, Metabolomics, urine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- 20 Nov 2016 (actual)
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 10 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with rheumatoid arthritis and healthy individuals
Key inclusion criteria (1 listed)
- All patients with rheumatoid arthritis meet 2010 American College of Rheumatology/European League against Rheumatism classification criteria.
Key exclusion criteria (7 listed)
- Comorbid with other autoimmune diseases
- Confirmed with amyloidosis
- Chronic kidney disease (estimated GFR < 60 ml/min/1.73m2)
- Chronic liver disease
- Thyroid disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 secondary outcome
Correlations between specific metabolites and disease activity/severity of RA
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jung Hee Koh, MD principal investigator
Seoul St. Mary's Hospital, The Catholic University of Korea
Questions about this trial
What is this clinical trial studying?
An observational study of RheumatoId Arthritis, run by The Catholic University of Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic fingerprint of rheumatoid arthritis (time frame: 1 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2018.