Prediction of Erosive Disease in Early Rheumatoid Arthritis (RA) by Ultrasound and Cartilage Biodegradation Markers

Erosive Disease in Early Rheumatoid Arthritis Clinical Trial

Official title:

Multicenter, Prospective, Open-label, Cohort Study With Collection of Blood Samples and Ultrasound / MRI and X-ray Examination

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02464384
• Other study ID #: UPEDRA01_01.07.2013
• Status: Not yet recruiting
• Phase: N/A
• First received: February 10, 2015
• Last updated: December 2, 2015
• Start date: April 2016
• Est. completion date: October 2019

Study information

• Verified date: December 2015
• Source: University of Zurich
• Contact: Adrian Ciurea, MD
• Phone: +41 44 255 29 58
• Email: adrian.ciurea[@]usz.ch
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical 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 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: October 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• persistent or recurrent infections

• Pregnancy or breast feeding

• no informed consent

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Erosive Disease in Early Rheumatoid Arthritis

Intervention

Procedure:
• Venipuncture, ultrasound, MRI, x-ray
Collection of blood samples and ultrasound / MRI and x-ray examination

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of the predictive value of US alone and in combination with cartilage biodegradation markers on radiographic progression (change in Ratingen score)		12 months	No
Secondary	Correlation of ultrasound synovitis score and clinical disease activity score		12 months	No
Secondary	Determination of the sensitivity of ultrasound erosion detection compared to MRI		12 months	No
Secondary	Assessment of the value of including tenosynovitis assessment for predicting radiographic progression		12 months	No
Secondary	Assessment of the predictive value of ultrasound synovitis score at baseline for the need to install biologic DMARDs		12 months	No