Assess Structural Damage in Rheumatoid Arthritis Using Biomarkers and Radiography

October 25, 2021 updated by: Canadian Research & Education in Arthritis

Prospective Validation of Soluble Biomarkers as Predictors of Structural Damage in Rheumatoid Arthritis

Recruited patients will include those about to begin Disease-Modifying Antirheumatic Drug) DMARD therapy or about to change DMARD therapy.

Disease activity will be monitored systematically every 3 months by the Disease Activity Score.

Changes in standard DMARD and/or anti-Tumor Necrosis Factor α (anti-TNFα) therapy will be made according to specific recommendations for patients receiving these therapies.

Biomarker samples will be collected every 3 months and prior to change in DMARD and/or anti-TNF therapy as defined below. A blood sample (40 ml) for serum will be taken for biomarker studies and processed according to the international committee of Outcome Measures in Rheumatology (OMERACT) recommendations for the minimal handling of biomarker samples. A urine sample (20 ml) will also be taken and processed as for serum.

Radiography (X-rays) will be conducted every 6 months (baseline, 6, 12, 18, 24 months).

Patients will be followed for 2 years.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Treatment is Disease Activity Score (DAS) driven. Changes in standard DMARD and/or anti-TNFα therapy will be implemented according to 2010 European League against Rheumatism (EULAR) recommendations which state a target of remission (DAS44 <1.6) for patients receiving standard DMARD therapy in the setting of early disease and a target of low disease activity state (LDAS) (DAS44 ≤2.4) for patients receiving anti-TNFα therapy in the setting of established disease.

Study Type

Observational

Enrollment (Actual)

571

Contacts and Locations

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

Study Locations

    • Alberta
      • Calgary, Alberta, Canada, T2N 4N1
        • University of Calgary
      • Edmonton, Alberta, Canada, T6G 2B7
        • Division of Rheumatology, University of Alberta Hospital
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1M4
        • Arthritis Center, University of Manitoba
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1C 5B3
        • Memorial University
    • Ontario
      • Newmarket, Ontario, Canada, L3Y 3R7
        • The Arthritis Research Group
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • University of Sherbrooke
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7K 0H6
        • Saskatoon Osteoporosis Centre
      • Glostrup, Denmark, DK-2600
        • Department of Rheumatology, Copenhagen University Hospital at Glostrup
      • Bordeaux, France, 33000
        • Service de Rheumatologie-CHU Bordeaux Pellegrin
      • Brest, France, 29200
        • Le Roux Liana, Centre d'Investigation Clinique
      • Lille, France
        • Centre des Consultations et imagerie de l'appareil locomoteur service de rheumatologie
      • Montpellier, France, 34295
        • Departement de rheumatologie, Hopital Lapeyronie
      • Paris, France, 75014
        • Rheumatologie B, Hopital Cochin
      • Toulouse, France, 31059
        • Infirmiere de Recherche Clinique, CHU de Toulouse, Centre de Rheumatologie, Hopital Purpan
      • Bad Nauheim, Germany, D-61231
        • Kerckhoff-Klinik, Department of Rheumatology and Clinical Immunology
      • Berlin, Germany
        • Department of Rheumatology/Clinical Immunology, Medizinische Klinik-Rheumatologie und Klinische Immunologie
      • Jena, Germany, 07747
        • Universitatsklinikum der Friedrich-Schiller-Universitat Jena, Klinik für Innere Medizin III/Rheumatologie/Osteologie
      • Zerbst, Germany, 39261
        • Dr Spieler
      • Dublin, Ireland
        • Department of Rheumatology, St. Vincents University Hospital
      • Tel Aviv, Israel, 64239
        • Tel Aviv Sourasky Medical Centre
      • Ferrara, Italy, 44121
        • University of Ferrara
      • Milan, Italy, 20157
        • University of Milan
      • Milano, Italy, 20122
        • Day Hospital Reumatologia
      • Padova, Italy, 35128
        • University of Padova
      • Rome, Italy, 00168
        • Catholic University of the Sacred Heart
      • Verona, Italy, 37067
        • Department of Rheumatology, University of Verona
      • Amsterdam, Netherlands, 0157 AB Amsterdam
        • Amsterdam VU University Medical Centre
      • Amsterdam, Netherlands, 1100 DE Amsterdam
        • Academic Medical Centre/University of Amsterdam
      • Heerlen, Netherlands, 6419 PC Heerlen
        • Academic Medical Centre/University of Amsterdam and Atrium Medical Centre Heerlen
      • Leiden, Netherlands, 2300 RC Leiden
        • Afdeling Reumatologie, Leids Universitair Medisch Centrum
      • Oslo, Norway, N-0027
        • Department of Rheumatology, Diakonhjemmet Hospital
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Johns Hopkins Arthritis Center, Johns Hopkins University
    • New York
      • New York, New York, United States, 10021
        • Rheumatologist Hospital for Special Surgery
      • New York, New York, United States, 10032
        • Division of Rheumatology, Columbia University, College of Physicians and Surgeons
      • Rochester, New York, United States, 14642
        • Division of Allergy, Immunology and Rheumatology, University of Rochester
    • Washington
      • Seattle, Washington, United States, 98104
        • Seattle Rheumatology Associates

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

Sampling Method

Non-Probability Sample

Study Population

RA patients from rheumatologists' clinics

Description

Inclusion Criteria (selected):

  • 18 years of age or older
  • RA according to the 2010 Rheumatoid Arthritis Classification Criteria
  • Joint symptoms for ≥ 3 months prior to screening
  • DAS44 > 2.4
  • About to start DMARD therapy (methotrexate, salazopyrin, hydroxychloroquine, chloroquine, leflunomide) or

    • increased dose of methotrexate by ≥10 mg weekly to a maximum dose of 25mg weekly (if already receiving >15mg will require add-on DMARD/anti-TNF or switch to alternative DMARD),
    • add-on of alternative DMARD,
    • switch to alternative DMARD,
    • start of first anti-TNFα agent (adalimumab, etanercept, infliximab, certolizumab pegol, golimumab)
  • If already on DMARD therapy this has been stable for the 3 months prior to the baseline visit
  • If already on systemic steroid, dose must be stable (prednisone ≤ 7.5mg/day) for 1 month prior to the baseline visit
  • Patient will be available for follow up for a minimum of 24 months from the baseline visit

Exclusion Criteria (selected):

  • Intra-articular steroid injection within 4 weeks prior to the baseline visit
  • Prior treatment with anti-TNFα or other biological agent (rituximab, abatacept, tocilizumab)
  • Malignancy within past 5 years (other than basal cell carcinoma that has been adequately treated or excised, squamous cell cancer of the skin, and cervical carcinoma in situ)
  • History of:

    • Serious infection (defined as requiring parenteral antibiotics or hospitalization) within 3 months prior to the baseline visit;
    • Active tuberculosis or history of tuberculosis without documented curative treatment and/or positive tuberculin reaction to PPD (Purified Protein Derivative)
  • For patients starting anti-TNF therapy, a positive TB screening test and no record of effective prophylaxis according to local expert recommendations
  • Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Rheumatoid Arthritis
RA patients on standard DMARD therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the independent predictive validity of several soluble biomarkers for predicting structural damage in Rheumatoid Arthritis (RA).
Time Frame: 24 Months
24 Months

Secondary Outcome Measures

Outcome Measure
Time Frame
To establish which modifiable clinical and laboratory predictors used in routine practice individually and in combination, have the strongest and the most consistent association with change in radiographic damage in patients on standard RA therapy.
Time Frame: 24 Months
24 Months

Collaborators and Investigators

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

Collaborators

Investigators

  • Study Director: Walter P. Maksymowych, MD, CaRE Arthritis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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 (Actual)

October 1, 2011

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

June 1, 2011

First Submitted That Met QC Criteria

November 18, 2011

First Posted (Estimate)

November 22, 2011

Study Record Updates

Last Update Posted (Actual)

October 27, 2021

Last Update Submitted That Met QC Criteria

October 25, 2021

Last Verified

October 1, 2021

More Information

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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