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

December 2, 2015 updated by: University of Zurich

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: cohort study
Collection of blood samples and ultrasound / MRI and x-ray examination.
Procedure: Venipuncture, ultrasound, MRI, x-ray
Collection of blood samples and ultrasound / MRI and x-ray examination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Correlation of ultrasound synovitis score and clinical disease activity score
Time Frame: 12 months
12 months
Determination of the sensitivity of ultrasound erosion detection compared to MRI
Time Frame: 12 months
12 months
Assessment of the value of including tenosynovitis assessment for predicting radiographic progression
Time Frame: 12 months
12 months
Assessment of the predictive value of ultrasound synovitis score at baseline for the need to install biologic DMARDs
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Investigators

  • Principal Investigator: Adrian Ciurea, MD, Department of Rheumatology, University Hospital Zurich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Anticipated)

April 1, 2019

Study Completion (Anticipated)

October 1, 2019

Study Registration Dates

First Submitted

February 10, 2015

First Submitted That Met QC Criteria

June 2, 2015

First Posted (Estimate)

June 8, 2015

Study Record Updates

Last Update Posted (Estimate)

December 3, 2015

Last Update Submitted That Met QC Criteria

December 2, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UPEDRA01_01.07.2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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