Assess Structural Damage in Rheumatoid Arthritis Using Biomarkers and Radiography
|First Received Date ICMJE||June 1, 2011|
|Last Updated Date||September 27, 2012|
|Start Date ICMJE||October 2011|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||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 ]|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT01476956 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||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 ]|
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Assess Structural Damage in Rheumatoid Arthritis Using Biomarkers and Radiography|
|Official Title ICMJE||Prospective Validation of Soluble Biomarkers as Predictors of Structural Damage in Rheumatoid Arthritis|
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.
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 Type ICMJE||Observational|
|Study Design ICMJE||Observational Model: Case-Only
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Biospecimen||Retention: Samples Without DNA
|Sampling Method||Non-Probability Sample|
RA patients from rheumatologists' clinics
|Condition ICMJE||Rheumatoid Arthritis|
|Intervention ICMJE||Other: Observational study
RA patients on standard DMARD therapy
|Study Group/Cohort (s)||Rheumatoid Arthritis
Intervention: Other: Observational study
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||600|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Inclusion Criteria (selected):
Exclusion Criteria (selected):
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Location Countries ICMJE||United States, Canada, Denmark, France, Germany, Ireland, Israel, Italy, Netherlands, Norway|
|NCT Number ICMJE||NCT01476956|
|Other Study ID Numbers ICMJE||RA BIODAM|
|Has Data Monitoring Committee||No|
|Responsible Party||Canadian Research & Education in Arthritis|
|Study Sponsor ICMJE||Canadian Research & Education in Arthritis|
|Information Provided By||Canadian Research & Education in Arthritis|
|Verification Date||November 2011|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP