Assess Structural Damage in Rheumatoid Arthritis Using Biomarkers and Radiography
Completed
Conditions studied: Rheumatoid Arthritis
In brief
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.
Key facts
- Study ID
- NCT01476956
- Run by
- CARE ARTHRITIS LTD.
- People needed
- 571
- Starts
- 2011-10-01
- Expected to finish
- 2019-12-31
- Last updated by the study team
- 2021-10-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Johns Hopkins Arthritis Center, Johns Hopkins University — Baltimore, Maryland, United States
- Rheumatologist Hospital for Special Surgery — New York, New York, United States
- Division of Rheumatology, Columbia University, College of Physicians and Surgeons — New York, New York, United States
- Division of Allergy, Immunology and Rheumatology, University of Rochester — Rochester, New York, United States
- Seattle Rheumatology Associates — Seattle, Washington, United States
- University of Calgary — Calgary, Alberta, Canada
- Division of Rheumatology, University of Alberta Hospital — Edmonton, Alberta, Canada
- Arthritis Center, University of Manitoba — Winnipeg, Manitoba, Canada
- Memorial University — St. John's, Newfoundland and Labrador, Canada
- The Arthritis Research Group — Newmarket, Ontario, Canada
- University of Sherbrooke — Sherbrooke, Quebec, Canada
- Saskatoon Osteoporosis Centre — Saskatoon, Saskatchewan, Canada
- Department of Rheumatology, Copenhagen University Hospital at Glostrup — Glostrup Municipality, Denmark
- Service de Rheumatologie-CHU Bordeaux Pellegrin — Bordeaux, France
- Le Roux Liana, Centre d'Investigation Clinique — Brest, France
- Centre des Consultations et imagerie de l'appareil locomoteur service de rheumatologie — Lille, France
- Departement de rheumatologie, Hopital Lapeyronie — Montpellier, France
- Rheumatologie B, Hopital Cochin — Paris, France
- Infirmiere de Recherche Clinique, CHU de Toulouse, Centre de Rheumatologie, Hopital Purpan — Toulouse, France
- Kerckhoff-Klinik, Department of Rheumatology and Clinical Immunology — Bad Nauheim, Germany
- Department of Rheumatology/Clinical Immunology, Medizinische Klinik-Rheumatologie und Klinische Immunologie — Berlin, Germany
- Universitatsklinikum der Friedrich-Schiller-Universitat Jena, Klinik für Innere Medizin III/Rheumatologie/Osteologie — Jena, Germany
- Dr Spieler — Zerbst, Germany
- Department of Rheumatology, St. Vincents University Hospital — Dublin, Ireland
- Tel Aviv Sourasky Medical Centre — Tel Aviv, Israel
Full record on ClinicalTrials.gov
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