Assess Structural Damage in Rheumatoid Arthritis Using Biomarkers and Radiography
NCT ID: NCT01476956
Last Updated: 2021-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
571 participants
OBSERVATIONAL
2011-10-31
2019-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Rheumatoid Arthritis
Observational study
RA patients on standard DMARD therapy
Interventions
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Observational study
RA patients on standard DMARD therapy
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
CARE ARTHRITIS LTD.
INDUSTRY
Responsible Party
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Principal Investigators
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Walter P. Maksymowych, MD
Role: STUDY_DIRECTOR
CaRE Arthritis
Locations
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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
University of Ferrara
Ferrara, , Italy
University of Milan
Milan, , Italy
Day Hospital Reumatologia
Milan, , Italy
University of Padova
Padua, , Italy
Catholic University of the Sacred Heart
Rome, , Italy
Department of Rheumatology, University of Verona
Verona, , Italy
Amsterdam VU University Medical Centre
Amsterdam, , Netherlands
Academic Medical Centre/University of Amsterdam
Amsterdam, , Netherlands
Academic Medical Centre/University of Amsterdam and Atrium Medical Centre Heerlen
Heerlen, , Netherlands
Afdeling Reumatologie, Leids Universitair Medisch Centrum
Leiden, , Netherlands
Department of Rheumatology, Diakonhjemmet Hospital
Oslo, , Norway
Countries
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References
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Sepriano A, Ramiro S, FitzGerald O, Ostergaard M, Homik J, van der Heijde D, Elkayam O, Thorne JC, Larche MJ, Ferraccioli G, Backhaus M, Burmester GR, Boire G, Combe B, Schaeverbeke T, Saraux A, Dougados M, Rossini M, Govoni M, Sinigaglia L, Cantagrel A, Barnabe C, Bingham CO 3rd, Tak PP, van Schaardenburg D, Hammer HB, Paschke J, Dadashova R, Hutchings E, Landewe R, Maksymowych WP. Adherence to Treat-to-target Management in Rheumatoid Arthritis and Associated Factors: Data from the International RA BIODAM Cohort. J Rheumatol. 2020 Jun 1;47(6):809-819. doi: 10.3899/jrheum.190303. Epub 2019 Sep 15.
Maksymowych WP, FitzGerald O, Ostergaard M, Homik J, van der Heijde D, Lambert RG, Elkayam O, Ramiro S, Thorne JC, Larche MJ, Ferraccioli G, Backhaus M, Burmester GR, Boire G, Combe B, Schaeverbeke T, Saraux A, Dougados M, Rossini M, Govoni M, Sinigaglia L, Cantagrel A, Barnabe C, Bingham CO 3rd, Tak PP, van Schaardenburg D, Hammer HB, Paschke J, Dadashova R, Hutchings E, Sepriano A, Landewe R. Outcomes and Findings of the International Rheumatoid Arthritis (RA) BIODAM Cohort for Validation of Soluble Biomarkers in RA. J Rheumatol. 2020 Jun 1;47(6):796-808. doi: 10.3899/jrheum.190302. Epub 2019 Sep 1.
Other Identifiers
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RA BIODAM
Identifier Type: -
Identifier Source: org_study_id