A Prospective, Single-centre, Randomised Study Evaluating the Clinical, Imaging and Immunological Depth of Remission Achieved by Very Early Versus Delayed Etanercept in Patients With Rheumatoid Arthritis (VEDERA)

NCT02433184 Phase 4 COMPLETED

The main aim of the study is to determine whether TNFi instituted as first-line therapy in early RA confers better outcomes (clinical, structural and immunological) compared to delayed TNFi start; implying particular dominance of TNF in early disease, a changing role of TNF with disease duration and hence, confirmation of a biological window of opportunity.

Details

Lead sponsor	University of Leeds
Phase	Phase 4
Status	COMPLETED
Enrolment	120
Start date	2011-07
Completion	2019-07

Conditions

• Rheumatoid Arthritis

Interventions

• Etanercept
• Methotrexate
• Sulfasalazine
• Hydroxychloroquine
• Etanercept
• Methotrexate

Primary outcomes

• Clinical remission — 48 weeks
  Proportion of patients that achieve clinical remission (Disease activity Score, DAS28 \<2.6) at 48 weeks, following either treatment strategy.

Countries

United Kingdom