The DANIsh VASculitis cohort study: protocol for a national multicenter prospective study including incident and prevalent patients with giant cell arteritis and polymyalgia rheumatica.

The DANIsh VASculitis cohort study, DANIVAS, is an observational national multicenter study with the overall aim to prospectively collect protocolized clinical data and biobank material from patients with polymyalgia rheumatica (PMR) and giant cell arteritis (GCA) diagnosed and/or followed at Danish rheumatology departments. A long-term key objective is to investigate whether the use of new clinically implemented diagnostic imaging modalities facilitates disease stratification in the GCA-PMR disease spectrum. In particular, we aim to evaluate treatment requirements in GCA patients with and without large-vessel involvement, treatment needs in PMR patients with and without subclinical giant cell arteritis, and the prognostic role of imaging with respect to aneurysm development. Hence, in GCA and PMR, imaging stratification is hypothesized to be able to guide management strategies. With an established infrastructure within rheumatology for clinical studies in Denmark, the infrastructure of the Danish Rheumatologic Biobank, and the possibility to cross-link data with valid nationwide registries, the DANIVAS project holds an exceptional possibility to collect comprehensive real-world data on diagnosis, disease severity, disease duration, treatment effect, complications, and adverse events. In this paper, we present the research protocol for the DANIVAS study.

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Copyright © 2024 Nielsen, Kristensen, Donskov, Terslev, Dreyer, Colic, Hetland, Højgaard, Ellingsen, Hauge, Chrysidis and Keller.

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BN has received speaker’s fees from Novartis and AbbVie. AC has received research grants from Novartis, Janssen, GSK, Syneos, and personal fees from UCB. LT has received speaker’s fees from Janssen, Pfizer, and Novartis. LD has received a research grant (paid to the institution) from BMS and AbbVie outside the present work; travel expenses from Janssen, UCB, and Boehringer Ingelheim. MH has received a research grant (paid to Institution) from AbbVie, BMS, Eli Lilly, MSD, Pfizer, Sandoz, and Novartis; speaker’s fee (paid to Institution) from Medac, Pfizer, Sandoz, and speaker’s fee (personal) from Novartis. E-MH has received fees for speaking and/or consulting from Novo, Novartis, and SynAct Pharma; research funding to Aarhus University Hospital from Novo Nordic Foundation, Galapagos, AbbVie; travel expenses from Pfizer, Sobi, and AbbVie. SC received speaker’s fee from Pfizer, Novartis, and Roche. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.