1. Prediction of response to Certolizumab-Pegol in rheumatoid arthritis (PreCePRA) by functional MRI of the brain – Study protocol for a randomized double-blind controlled study
- Author
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Schenker, H.M., Tascilar, K., Konerth, L., Sergeeva, M., Prade, J., Strobelt, S., Kleyer, A., Simon, D., Mendez, L., Hagen, M., Schönau, V., Hueber, A., Roesch, J., Dörfler, A., Hess, A., Schett, G., and Rech, J.
- Subjects
Medicine (General) ,R5-920 ,functional MRI ,TNF inhibition ,Neuroimaging ,ddc:610 ,Rheumatoid arthritis ,Article - Abstract
Background Tumor necrosis factor inhibitors (TNFi) signify a major advance in the treatment of rheumatoid arthritis (RA). However, treatment success initially remains uncertain as approximately half of the patients do not respond adequately to TNFi. Thus, an unmet need exists to better predict therapeutic outcome of biologicals. Objectives We investigated whether brain activity associated with arthritis measured by functional magnetic resonance imaging (fMRI) of the brain can serve as a predictor of response to TNFi in RA patients. Methods PreCePRA is a multi-center, randomized, double-blind, placebo-controlled fMRI trial on patients with RA [1] [2]. Active RA patients failing csDMARDs therapy with a DAS28 > 3.2 and at least three tender and/or swollen joints underwent a brain BOLD (blood-oxygen-level dependent) fMRI scan upon joint compression at screening. Patients were then randomized into a 12-week double-blinded treatment phase with 200 mg Certolizumab Pegol (CZP) every two weeks (arm 1: fMRI BOLD signal activated volume > 2000 voxel, i.e. 2 cm3; arm 2: fMRI BOLD signal activated volume
- Published
- 2021