NCT01476956

Assess Structural Damage in Rheumatoid Arthritis Using Biomarkers and Radiography

Prospective Validation of Soluble Biomarkers as Predictors of Structural Damage in Rheumatoid Arthritis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 571 (actual)
• Sponsor: CARE ARTHRITIS LTD. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
OTHER	Observational study	RA patients on standard DMARD therapy

Timeline

• Start date: 2011-10-01
• Primary completion: 2017-12-31
• Completion: 2019-12-31
• First posted: 2011-11-22
• Last updated: 2021-10-27

Locations

36 sites across 10 countries: United States, Canada, Denmark, France, Germany, Ireland, Israel, Italy, Netherlands, Norway