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

Schenker H, 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, Rech J (2021)

Publication Type: Journal article

Publication year: 2021

Journal

Contemporary Clinical Trials Communications Elsevier

Book Volume: 22

Article Number: 100770

DOI: 10.1016/j.conctc.2021.100770

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 <2000 voxel) or placebo (arm 3). DAS28 low disease activity at 12 weeks was assigned as primary endpoint. A 12-week follow-up phase in which patients were switched from the placebo to the treatment arm followed the blinded phase. fMRI was carried out at screening as well as after 12 and 24 weeks of receiving CZP or placebo. Conclusion: We hypothesize that high-level central nervous representation of pain in patients with rheumatoid arthritis predicts response to the TNFi CZP which we further investigate in the PreCePRA trial.

Authors with CRIS profile

Hannah Schenker Department of Medicine 3 – Rheumatology and Immunology Koray Tascilar Department of Medicine 3 – Rheumatology and Immunology Laura Konerth Lehrstuhl für Pharmakologie und Toxikologie Marina Sergeeva Lehrstuhl für Pharmakologie und Toxikologie Jutta Prade Lehrstuhl für Pharmakologie und Toxikologie Sandra Strobelt Lehrstuhl für Pharmakologie und Toxikologie Arnd Kleyer Department of Medicine 3 – Rheumatology and Immunology David Simon Department of Medicine 3 – Rheumatology and Immunology Melanie Hagen Department of Medicine 3 – Rheumatology and Immunology Johannes Roesch Department of Radiation Oncology Arnd Dörfler Department of Neuroradiology Andreas Heß Lehrstuhl für Pharmakologie und Toxikologie Georg Schett Lehrstuhl für Innere Medizin III Hans Jürgen Rech Department of Medicine 3 – Rheumatology and Immunology

How to cite

APA:

Schenker, H., Tascilar, K., Konerth, L., Sergeeva, M., Prade, J., Strobelt, S.,... Rech, J. (2021). 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. Contemporary Clinical Trials Communications, 22. https://doi.org/10.1016/j.conctc.2021.100770

MLA:

Schenker, Hannah, et al. "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." Contemporary Clinical Trials Communications 22 (2021).

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