Assess Structural Damage in Rheumatoid Arthritis Using Biomarkers and Radiography
Recruitment status was Recruiting
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Prospective Validation of Soluble Biomarkers as Predictors of Structural Damage in Rheumatoid Arthritis|
- To determine the independent predictive validity of several soluble biomarkers for predicting structural damage in Rheumatoid Arthritis (RA). [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
- whole blood/serum
|Study Start Date:||October 2011|
Other: Observational study
RA patients on standard DMARD therapy
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01476956
|Contact: Rana Dadashovafirstname.lastname@example.org|
Show 33 Study Locations
|Study Director:||Walter P. Maksymowych, MD||CaRE Arthritis|