B1801031 Etanercept vs placebo in early non radiographic axial SpA
Research type
Research Study
Full title
A MULTICENTRE, 12 WEEK DOUBLE BLIND PLACEBO CONTROLLED RANDOMIZED STUDY OF ETANERCEPT ON A BACKGROUND NSAID IN THE TREATMENT OF ADULT SUBJECTS WITH NON RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS WITH A 92 WEEK OPEN LABEL EXTENSION
IRAS ID
76006
Sponsor organisation
Pfizer Inc, 235 East 42nd Street, New York, NY 10017
Eudract number
2010-020077-16
Clinicaltrials.gov Identifier
Research summary
Recent data suggest that in earlier stages of Axial Spondyloarthritis (AxSpA), inflammation drives new bone formation.Later, inflammation and bone formation might become independent of each other, therefore decreasing inflammation would not be enough to prevent new bone formation, and on the contrary, it might facilitate it.Therefore, it has been hypothesized that the early use of Etanercept (ETN) a recombinant human tumor necrosis factor alpha (TNFÇÂ) soluble receptor that blocks TNFÇ binding to cell surface receptors and initiation of intracellular signaling before the bone formation process becomes uncoupled from inflammation, might have a beneficial effect on the anatomical progression of AxSpA.The primary objective of this study is to compare the clinical efficacy of Etanercept 50 mg once a week with placebo when added to a background NSAID in subjects with active nonradiographic AxSpA that failed to respond to NSAIDs.This study will also provide needed data regarding the long term efficacy of the combination of Etanercept plus NSAID therapy in this disease state. Additionally, there is a potential that this study may lead to a better understanding of the role of Etanercept in the structural progression of axial SpA in a population that is earlier in the disease course than the ones previously studied.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
11/EM/0165
Date of REC Opinion
18 Jul 2011
REC opinion
Further Information Favourable Opinion