Assess Structural Damage in Rheumatoid Arthritis Using Biomarkers and Radiography

RA patients from rheumatologists' clinics

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

  • 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 (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)
• 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