drugset / Trial / NCT02433184
Very Early Versus Delayed Etanercept in Patients With RA
RandomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2011-07
- Primary completion
- 2017-08
- Completion
- 2019-07
Publications
- Emery P, Horton S, Dumitru RB, Naraghi K, van der Heijde D, Wakefield RJ, Hensor EMA, Buch MH. Pragmatic randomised controlled trial of very early etanercept and MTX versus MTX with delayed etanercept in RA: the VEDERA trial. Ann Rheum Dis. 2020 Apr;79(4):464-471. doi: 10.1136/annrheumdis-2019-216539. Epub 2020 Jan 29.
- Dumitru RB, Horton S, Hodgson R, Wakefield RJ, Hensor EMA, Emery P, Buch MH. 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). BMC Musculoskelet Disord. 2016 Feb 5;17:61. doi: 10.1186/s12891-016-0915-0.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Etanercept | Protein / enzyme biologic | 50 mg | Subcutaneous |
| Subject | Methotrexate | Small molecule | 25 mg | Oral |
| Comparator | Hydroxychloroquine | Small molecule | 200 mg | — |
| Comparator | Sulfasalazine | Small molecule | 1 g | Oral |