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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Canada
    • 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
  • Denmark
      • Glostrup, Denmark, DK-2600
        • Department of Rheumatology, Copenhagen University Hospital at Glostrup
  • France
      • 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
  • Germany
      • 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
  • Ireland
      • Dublin, Ireland
        • Department of Rheumatology, St. Vincents University Hospital
  • Israel
      • Tel Aviv, Israel, 64239
        • Tel Aviv Sourasky Medical Centre
  • Italy
      • 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
  • Netherlands
      • 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
  • Norway
      • Oslo, Norway, N-0027
        • Department of Rheumatology, Diakonhjemmet Hospital
  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Rheumatoid Arthritis
Other: Observational study
RA patients on standard DMARD therapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Canadian Research & Education in Arthritis

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Abbott

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 1, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 22, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 27, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 25, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RA BIODAM

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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