Assess Structural Damage in Rheumatoid Arthritis Using Biomarkers and Radiography
This trial is active, not recruiting.
|Sponsor||Canadian Research & Education in Arthritis|
|Start date||October 2011|
|End date||April 2017|
|Trial size||600 participants|
|Trial identifier||NCT01476956, RA BIODAM|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Baltimore, MD||Johns Hopkins Arthritis Center, Johns Hopkins University||no longer recruiting|
|New York, NY||Rheumatologist Hospital for Special Surgery||no longer recruiting|
|New York, NY||Division of Rheumatology, Columbia University, College of Physicians and Surgeons||no longer recruiting|
|Rochester, NY||Division of Allergy, Immunology and Rheumatology, University of Rochester||no longer recruiting|
|Seattle, WA||Seattle Rheumatology Associates||no longer recruiting|
|Calgary, Canada||University of Calgary||no longer recruiting|
|Edmonton, Canada||Division of Rheumatology, University of Alberta Hospital||no longer recruiting|
|Winnipeg, Canada||Arthritis Center, University of Manitoba||no longer recruiting|
|St. John's, Canada||Memorial University||no longer recruiting|
|Newmarket, Canada||The Arthritis Research Group||no longer recruiting|
|Sherbrooke, Canada||University of Sherbrooke||no longer recruiting|
|Saskatoon, Canada||Saskatoon Osteoporosis Centre||no longer recruiting|
|Glostrup, Denmark||Department of Rheumatology, Copenhagen University Hospital at Glostrup||no longer recruiting|
|Bordeaux, France||Service de Rheumatologie-CHU Bordeaux Pellegrin||no longer recruiting|
|Brest, France||Le Roux Liana, Centre d'Investigation Clinique||no longer recruiting|
|Lille, France||Centre des Consultations et imagerie de l'appareil locomoteur service de rheumatologie||no longer recruiting|
|Montpellier, France||Departement de rheumatologie, Hopital Lapeyronie||no longer recruiting|
|Paris, France||Rheumatologie B, Hopital Cochin||no longer recruiting|
|Toulouse, France||Infirmiere de Recherche Clinique, CHU de Toulouse, Centre de Rheumatologie, Hopital Purpan||no longer recruiting|
|Bad Nauheim, Germany||Kerckhoff-Klinik, Department of Rheumatology and Clinical Immunology||no longer recruiting|
|Berlin, Germany||Department of Rheumatology/Clinical Immunology, Medizinische Klinik-Rheumatologie und Klinische Immunologie||no longer recruiting|
|Jena, Germany||Universitatsklinikum der Friedrich-Schiller-Universitat Jena, Klinik für Innere Medizin III/Rheumatologie/Osteologie||no longer recruiting|
|Zerbst, Germany||Dr Spieler||no longer recruiting|
|Dublin, Ireland||Department of Rheumatology, St. Vincents University Hospital||no longer recruiting|
|Tel Aviv, Israel||Tel Aviv Sourasky Medical Centre||no longer recruiting|
|Ferrara, Italy||University of Ferrara||no longer recruiting|
|Milano, Italy||Day Hospital Reumatologia||no longer recruiting|
|Milan, Italy||University of Milan||no longer recruiting|
|Padova, Italy||University of Padova||no longer recruiting|
|Rome, Italy||Catholic University of the Sacred Heart||no longer recruiting|
|Verona, Italy||Department of Rheumatology, University of Verona||no longer recruiting|
|Amesterdam, Netherlands||Academic Medical Centre/University of Amsterdam||no longer recruiting|
|Amsterdam, Netherlands||Amsterdam VU University Medical Centre||no longer recruiting|
|Heerlen, Netherlands||Academic Medical Centre/University of Amsterdam and Atrium Medical Centre Heerlen||no longer recruiting|
|Leiden, Netherlands||Afdeling Reumatologie, Leids Universitair Medisch Centrum||no longer recruiting|
|Oslo, Norway||Department of Rheumatology, Diakonhjemmet Hospital||no longer recruiting|
To determine the independent predictive validity of several soluble biomarkers for predicting structural damage in Rheumatoid Arthritis (RA).
time frame: 24 Months
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
Male or female participants at least 18 years old.
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
|Official title||Prospective Validation of Soluble Biomarkers as Predictors of Structural Damage in Rheumatoid Arthritis|
|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.|
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