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

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ClinicalTrials.gov Identifier: NCT02464384
Recruitment Status : Unknown
Verified December 2015 by University of Zurich.
Recruitment status was:  Not yet recruiting
First Posted : June 8, 2015
Last Update Posted : December 3, 2015
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Brief 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

Condition or disease Intervention/treatment Phase
Erosive Disease in Early Rheumatoid Arthritis Procedure: Venipuncture, ultrasound, MRI, x-ray Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Multicenter, Prospective, Open-label, Cohort Study With Collection of Blood Samples and Ultrasound / MRI and X-ray Examination
Study Start Date : April 2016
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

Drug Information available for: X-Rays

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Correlation of ultrasound synovitis score and clinical disease activity score [ Time Frame: 12 months ]
  2. Determination of the sensitivity of ultrasound erosion detection compared to MRI [ Time Frame: 12 months ]
  3. Assessment of the value of including tenosynovitis assessment for predicting radiographic progression [ Time Frame: 12 months ]
  4. Assessment of the predictive value of ultrasound synovitis score at baseline for the need to install biologic DMARDs [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02464384


Contacts
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Contact: Adrian Ciurea, MD +41 44 255 29 58 adrian.ciurea@usz.ch
Contact: Mariusz Wasila, MD +41 44 255 29 99 mariusz.wasila@usz.ch

Sponsors and Collaborators
University of Zurich
Investigators
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Principal Investigator: Adrian Ciurea, MD Department of Rheumatology, University Hospital Zurich

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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02464384     History of Changes
Other Study ID Numbers: UPEDRA01_01.07.2013
First Posted: June 8, 2015    Key Record Dates
Last Update Posted: December 3, 2015
Last Verified: December 2015
Keywords provided by University of Zurich:
ultrasound and cartilage biodegradation markers
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases