Erosive Disease in Early Rheumatoid ArthritisNCT02464384
Prediction of Erosive Disease in Early Rheumatoid Arthritis (RA) by Ultrasound and Cartilage Biodegradation Markers
A study testing Venipuncture, ultrasound, MRI, x-ray in people with Erosive Disease in Early Rheumatoid Arthritis, run by University of Zurich.
Trial summary
Multicenter, prospective, open-label, cohort study. Primary objective: Determination of the predictive value of US alone and in combination with cartilage biodegradation markers on radiographic progression (change in Ratingen score) Secondary objectives: Correlation of ultrasound synovitis score and clinical disease… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Erosive Disease in Early Rheumatoid Arthritis
- What is being tested?
- Venipuncture, ultrasound, MRI, x-ray
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Oct 2019
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients fulfilling all of the following inclusion criteria may be enrolled in the study:
- male and female subjects, Age above 18 yrs
- recent onset RA fulfilling the American College of Rheumatology (ACR) criteria (revised 2010)
- Symptoms for at least 6 weeks
- no previous DMARD treatment
- no intraarticular steroid injections in the last 4 weeks before inclusion
- no treatment with oral steroids exceeding the equivalent of 10mg prednisone per day in the last 2 weeks before inclusion
- signed Informed Consent after being informed
Who cannot join
- History of inflammatory joint disease other than RA
- History of active Tbc, histoplasmosis or listeriosis
- History of lymphoma or other malignancies within 5 years
- Contraindication for the use of DMARD's or biologics
- Comorbidities: severe myocardial dysfunction, recent stroke (within 3 months), uncontrolled diabetes and other disease which in the opinion of the investigator, would put the subject at risk by participation in the trial
- History of demyelinating disorders
Show all 9Show fewer
- persistent or recurrent infections
- Pregnancy or breast feeding
- no informed consent
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Multicenter, Prospective, Open-label, Cohort Study With Collection of Blood Samples and Ultrasound / MRI and X-ray Examination
Multicenter, prospective, open-label, cohort study. Primary objective: Determination of the predictive value of US alone and in combination with cartilage biodegradation markers on radiographic progression (change in Ratingen score)
Secondary objectives:
- Correlation of ultrasound synovitis score and clinical disease activity score
- Determination of the sensitivity of ultrasound erosion detection compared to MRI
- Assessment of the value of including tenosynovitis assessment for predicting radiographic progression
- Assessment of the predictive value of ultrasound synovitis score at baseline for the need to install biologic DMARDs
Read the detailed description
Multicenter, prospective, open-label, cohort study with collection of blood samples and ultrasound / MRI and x-ray examination.
Duration of study: 12 months This study is a prospective cohort study. The choice of therapy at any time during the study is entirely up to the treating rheumatologist. The study does not put any restriction on the management of the patient which will be according to routine care.
At occurrence of one or more of the above mentioned variables defining adverse clinical outcome (prednisone in a dose exceeding 10mg/d and/or intraarticular steroid injections and/or start of biologic DMARD) an analysis as for D360 will be performed US-Score: SONAR-Score assessment of synovitis (22 joints)/erosions (14 joints)/cartilage thickness (8 joints) Clinical evaluation: Disease activity score (DAS28 = Number of tender and swollen joints (0-28), additional measures (ESR / CRP), Patient Global Health (0-100), health assessment questionnaire (HAQ) at 0, 3, 6, 9, 12 months (attached) Lab: ESR, CRP Serology: Antinuclear antibody (ANA), Rheumatoid factor (RF), Anti-cyclic citrullinated peptide (anti-CCP) at baseline if not available COL2-1 / COL2-1N X-Ray: hands and feet at baseline and 12 months (scoring according to Ratingen Score) if not available MRI without contrast at baseline and at 12 months or when first erosions detected with US
- Being tested
- Venipuncture, ultrasound, MRI, x-ray
- Keywords
- ultrasound and cartilage biodegradation markers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venipuncture, ultrasound, MRI, x-rayProcedure or surgery
Collection of blood samples and ultrasound / MRI and x-ray examination
| Study group | Role | What they receive |
|---|---|---|
| cohort study | Other | Collection of blood samples and ultrasound / MRI and x-ray examination. Receives: Procedure: Venipuncture, ultrasound, MRI, x-ray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the predictive value of US alone and in combination with cartilage biodegradation markers on radiographic progression (change in Ratingen score)
Measured: 12 months
Secondary outcomes (4)
Correlation of ultrasound synovitis score and clinical disease activity score
Measured: 12 months
Determination of the sensitivity of ultrasound erosion detection compared to MRI
Measured: 12 months
Assessment of the value of including tenosynovitis assessment for predicting radiographic progression
Measured: 12 months
Assessment of the predictive value of ultrasound synovitis score at baseline for the need to install biologic DMARDs
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study startApr 2016
- Primary completionApr 2019 (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 Erosive Disease in Early Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adrian Ciurea, MD, Principal investigator, Department of Rheumatology, University Hospital Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02464384
- Sponsor's protocol ID
- UPEDRA01_01.07.2013
- Status last verified
- Dec 2015
- First submitted
- 10 Feb 2015
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Prospective, Open-label, Cohort Study With Collection of Blood Samples and Ultrasound / MRI and X-ray Examination
- ClinicalTrials.gov ID
- NCT02464384
- Acronym / sponsor ID
- UPEDRA01_01.07.2013
- Keywords
- ultrasound and cartilage biodegradation markers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 8 Jun 2015 (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.
Multicenter, prospective, open-label, cohort study. Primary objective: Determination of the predictive value of US alone and in combination with cartilage biodegradation markers on radiographic progression (change in Ratingen score)
Secondary objectives:
- Correlation of ultrasound synovitis score and clinical disease activity score
- Determination of the sensitivity of ultrasound erosion detection compared to MRI
- Assessment of the value of including tenosynovitis assessment for predicting radiographic progression
- Assessment of the predictive value of ultrasound synovitis score at baseline for the need to install biologic DMARDs
Detailed description
Multicenter, prospective, open-label, cohort study with collection of blood samples and ultrasound / MRI and x-ray examination.
Duration of study: 12 months This study is a prospective cohort study. The choice of therapy at any time during the study is entirely up to the treating rheumatologist. The study does not put any restriction on the management of the patient which will be according to routine care.
At occurrence of one or more of the above mentioned variables defining adverse clinical outcome (prednisone in a dose exceeding 10mg/d and/or intraarticular steroid injections and/or start of biologic DMARD) an analysis as for D360 will be performed US-Score: SONAR-Score assessment of synovitis (22 joints)/erosions (14 joints)/cartilage thickness (8 joints) Clinical evaluation: Disease activity score (DAS28 = Number of tender and swollen joints (0-28), additional measures (ESR / CRP), Patient Global Health (0-100), health assessment questionnaire (HAQ) at 0, 3, 6, 9, 12 months (attached) Lab: ESR, CRP Serology: Antinuclear antibody (ANA), Rheumatoid factor (RF), Anti-cyclic citrullinated peptide (anti-CCP) at baseline if not available COL2-1 / COL2-1N X-Ray: hands and feet at baseline and 12 months (scoring according to Ratingen Score) if not available MRI without contrast at baseline and at 12 months or when first erosions detected with US
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cohort study | Other | Procedure: Venipuncture, ultrasound, MRI, x-rayCollection of blood samples and ultrasound / MRI and x-ray examination. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients fulfilling all of the following inclusion criteria may be enrolled in the study:
- male and female subjects, Age above 18 yrs
- recent onset RA fulfilling the American College of Rheumatology (ACR) criteria (revised 2010)
- Symptoms for at least 6 weeks
- no previous DMARD treatment
Key exclusion criteria (9 listed)
- History of inflammatory joint disease other than RA
- History of active Tbc, histoplasmosis or listeriosis
- History of lymphoma or other malignancies within 5 years
- Contraindication for the use of DMARD's or biologics
- Comorbidities: severe myocardial dysfunction, recent stroke (within 3 months), uncontrolled diabetes and other disease which in the opinion of the investigator, would put the subject at risk by participation in the trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Venipuncture, ultrasound, MRI, x-rayCollection of blood samples and ultrasound / MRI and x-ray examination | Procedure or surgery | cohort study |
Primary outcome
Determination of the predictive value of US alone and in combination with cartilage biodegradation markers on radiographic progression (change in Ratingen score)
Time frame: 12 months
4 secondary outcomes
Correlation of ultrasound synovitis score and clinical disease activity score
Time frame: 12 months
Determination of the sensitivity of ultrasound erosion detection compared to MRI
Time frame: 12 months
Assessment of the value of including tenosynovitis assessment for predicting radiographic progression
Time frame: 12 months
Assessment of the predictive value of ultrasound synovitis score at baseline for the need to install biologic DMARDs
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
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.
Adrian Ciurea, MD principal investigator
Department of Rheumatology, University Hospital Zurich
Questions about this trial
What is this clinical trial studying?
A study testing Venipuncture, ultrasound, MRI, x-ray in people with Erosive Disease in Early Rheumatoid Arthritis, run by University of Zurich.
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 8 inclusion and 9 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 3 Dec 2015. 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?
Contact Adrian Ciurea, MD (+41 44 255 29 58, adrian.ciurea@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of the predictive value of US alone and in combination with cartilage biodegradation markers on radiographic progression (change in Ratingen score) (time frame: 12 months). 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 3 Dec 2015.