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Assess Structural Damage in Rheumatoid Arthritis Using Biomarkers and Radiography

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ClinicalTrials.gov Identifier: NCT01476956
Recruitment Status : Active, not recruiting
First Posted : November 22, 2011
Last Update Posted : November 18, 2016
Information provided by (Responsible Party):
Canadian Research & Education in Arthritis

Brief Summary:

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.

Condition or disease Intervention/treatment
Rheumatoid Arthritis Other: Observational study

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
Estimated Enrollment : 600 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Validation of Soluble Biomarkers as Predictors of Structural Damage in Rheumatoid Arthritis
Study Start Date : October 2011
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Rheumatoid Arthritis Other: Observational study
RA patients on standard DMARD therapy

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

Secondary Outcome Measures :
  1. 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 ]

Biospecimen Retention:   Samples Without DNA
  • whole blood/serum
  • urine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
RA patients from rheumatologists' clinics

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

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): NCT01476956

  Show 36 Study Locations
Sponsors and Collaborators
Canadian Research & Education in Arthritis
Study Director: Walter P. Maksymowych, MD CaRE Arthritis

Responsible Party: Canadian Research & Education in Arthritis
ClinicalTrials.gov Identifier: NCT01476956     History of Changes
Other Study ID Numbers: RA BIODAM
First Posted: November 22, 2011    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases