Assess Structural Damage in Rheumatoid Arthritis Using Biomarkers and Radiography
Study Details
Study Description
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 | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Rheumatoid Arthritis
|
Other: Observational study
RA patients on standard DMARD therapy
|
Outcome Measures
Primary Outcome Measures
- To determine the independent predictive validity of several soluble biomarkers for predicting structural damage in Rheumatoid Arthritis (RA). [24 Months]
Secondary Outcome Measures
- 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. [24 Months]
Eligibility Criteria
Criteria
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
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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)
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If already on DMARD therapy this has been stable for the 3 months prior to the baseline visit
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If already on systemic steroid, dose must be stable (prednisone ≤ 7.5mg/day) for 1 month prior to the baseline visit
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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)
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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)
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History of:
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Johns Hopkins Arthritis Center, Johns Hopkins University | Baltimore | Maryland | United States | 21224 |
| 2 | Rheumatologist Hospital for Special Surgery | New York | New York | United States | 10021 |
| 3 | Division of Rheumatology, Columbia University, College of Physicians and Surgeons | New York | New York | United States | 10032 |
| 4 | Division of Allergy, Immunology and Rheumatology, University of Rochester | Rochester | New York | United States | 14642 |
| 5 | Seattle Rheumatology Associates | Seattle | Washington | United States | 98104 |
| 6 | University of Calgary | Calgary | Alberta | Canada | T2N 4N1 |
| 7 | Division of Rheumatology, University of Alberta Hospital | Edmonton | Alberta | Canada | T6G 2B7 |
| 8 | Arthritis Center, University of Manitoba | Winnipeg | Manitoba | Canada | R3A 1M4 |
| 9 | Memorial University | St. John's | Newfoundland and Labrador | Canada | A1C 5B3 |
| 10 | The Arthritis Research Group | Newmarket | Ontario | Canada | L3Y 3R7 |
| 11 | University of Sherbrooke | Sherbrooke | Quebec | Canada | J1H 5N4 |
| 12 | Saskatoon Osteoporosis Centre | Saskatoon | Saskatchewan | Canada | S7K 0H6 |
| 13 | Department of Rheumatology, Copenhagen University Hospital at Glostrup | Glostrup | Denmark | DK-2600 | |
| 14 | Service de Rheumatologie-CHU Bordeaux Pellegrin | Bordeaux | France | 33000 | |
| 15 | Le Roux Liana, Centre d'Investigation Clinique | Brest | France | 29200 | |
| 16 | Centre des Consultations et imagerie de l'appareil locomoteur service de rheumatologie | Lille | France | ||
| 17 | Departement de rheumatologie, Hopital Lapeyronie | Montpellier | France | 34295 | |
| 18 | Rheumatologie B, Hopital Cochin | Paris | France | 75014 | |
| 19 | Infirmiere de Recherche Clinique, CHU de Toulouse, Centre de Rheumatologie, Hopital Purpan | Toulouse | France | 31059 | |
| 20 | Kerckhoff-Klinik, Department of Rheumatology and Clinical Immunology | Bad Nauheim | Germany | D-61231 | |
| 21 | Department of Rheumatology/Clinical Immunology, Medizinische Klinik-Rheumatologie und Klinische Immunologie | Berlin | Germany | ||
| 22 | Universitatsklinikum der Friedrich-Schiller-Universitat Jena, Klinik für Innere Medizin III/Rheumatologie/Osteologie | Jena | Germany | 07747 | |
| 23 | Dr Spieler | Zerbst | Germany | 39261 | |
| 24 | Department of Rheumatology, St. Vincents University Hospital | Dublin | Ireland | ||
| 25 | Tel Aviv Sourasky Medical Centre | Tel Aviv | Israel | 64239 | |
| 26 | University of Ferrara | Ferrara | Italy | 44121 | |
| 27 | Day Hospital Reumatologia | Milano | Italy | 20122 | |
| 28 | University of Milan | Milan | Italy | 20157 | |
| 29 | University of Padova | Padova | Italy | 35128 | |
| 30 | Catholic University of the Sacred Heart | Rome | Italy | 00168 | |
| 31 | Department of Rheumatology, University of Verona | Verona | Italy | 37067 | |
| 32 | Amsterdam VU University Medical Centre | Amsterdam | Netherlands | 0157 AB Amsterdam | |
| 33 | Academic Medical Centre/University of Amsterdam | Amsterdam | Netherlands | 1100 DE Amsterdam | |
| 34 | Academic Medical Centre/University of Amsterdam and Atrium Medical Centre Heerlen | Heerlen | Netherlands | 6419 PC Heerlen | |
| 35 | Afdeling Reumatologie, Leids Universitair Medisch Centrum | Leiden | Netherlands | 2300 RC Leiden | |
| 36 | Department of Rheumatology, Diakonhjemmet Hospital | Oslo | Norway | N-0027 |
Sponsors and Collaborators
- Canadian Research & Education in Arthritis
- Abbott
Investigators
- Study Director: Walter P. Maksymowych, MD, CaRE Arthritis
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RA BIODAM