The Meteoritics Trial: efficacy of methotrexate after remission-induction with tocilizumab and glucocorticoids in giant cell arteritis-study protocol for a randomized, double-blind, placebo-controlled, parallel-group phase II study.

"Declarations Ethics approval and consent to participate {24}This study was approved by both the Ethics Committee of the regional medical association of Rheinland-Pfalz and the European Medicines Agency. Written, informed consent to participate will be obtained from all participants. Consent for publication {32}Not applicable. Competing interests {28}CD has received grant support, compensation for consultancies and speakers’ fees from AbbVie and Novartis, compensation for consultancies and speakers’ fees from Galapagos, Lilly, AbbVie, Pfizer, Roche, Sanofi, Janssen, compensation for consultancies from Sparrow.WAS has received honoraria as a speaker from Abbvie, Amgen, Bristol Myers Squibb, Chugai, GlaxoSmithKline, Johnson & Johnson, Medac, Novartis, Roche, and UCB. He has been a member of advisory boards for Abbvie, Amgen, GlaxoSmithKline, Novartis, and Sanofi. He participated as principal investigator for trials sponsored by Abbvie, GlaxoSmithKline, Novartis, and Sanofi.NV declares speaker honorarium from AbbVie, AstraZeneca, Novartis, Boehringer Ingelheim, Bristol Myers Squibb, Chugai, Roche, Janssen, Pfizer, UCB, GlaxoSmithKline, and Vifor; being an advisory board member for AbbVie, Chugai, Novartis, UCB, and Vifor; consulting fees from Novartis, AbbVie, Chugai, and Vifor; research grants from Bristol Myers Squibb and Novartis; meeting or travel grants from Bristol Myers Squibb, Novartis, AbbVie, and Vifor; and expert testimony for Novartis, Vifor, and AbbVie. NV is named on the Novartis patent application for secukinumab in the treatment of giant cell arteritis.VSS has received honoraria as a speaker from AbbVie, Novartis, BMS, Chugai, Celgene, Medac, Sanofi, Lilly, Hexal, Pfizer, Janssen, Roche, Schire, Onkowissen, Royal College London, Boehringer-Ingelheim, Rheumaakademie; consulting fees from Novartis, Chugai, AbbVie, Celgene, Sanofi, Lilly, Hexal, Pfizer, Amgen, BMS, Roche, Gilead, Medac, Boehringer-Ingelheim and research support from Novartis, Hexal, Lilly, Roche, Celgene, Universität Bonn, Boehringer-Ingelheim, BMBF.RN and LK have no conflict of interest to declare. Competing interests {28} CD has received grant support, compensation for consultancies and speakers’ fees from AbbVie and Novartis, compensation for consultancies and speakers’ fees from Galapagos, Lilly, AbbVie, Pfizer, Roche, Sanofi, Janssen, compensation for consultancies from Sparrow. WAS has received honoraria as a speaker from Abbvie, Amgen, Bristol Myers Squibb, Chugai, GlaxoSmithKline, Johnson & Johnson, Medac, Novartis, Roche, and UCB. He has been a member of advisory boards for Abbvie, Amgen, GlaxoSmithKline, Novartis, and Sanofi. He participated as principal investigator for trials sponsored by Abbvie, GlaxoSmithKline, Novartis, and Sanofi. NV declares speaker honorarium from AbbVie, AstraZeneca, Novartis, Boehringer Ingelheim, Bristol Myers Squibb, Chugai, Roche, Janssen, Pfizer, UCB, GlaxoSmithKline, and Vifor; being an advisory board member for AbbVie, Chugai, Novartis, UCB, and Vifor; consulting fees from Novartis, AbbVie, Chugai, and Vifor; research grants from Bristol Myers Squibb and Novartis; meeting or travel grants from Bristol Myers Squibb, Novartis, AbbVie, and Vifor; and expert testimony for Novartis, Vifor, and AbbVie. NV is named on the Novartis patent application for secukinumab in the treatment of giant cell arteritis. VSS has received honoraria as a speaker from AbbVie, Novartis, BMS, Chugai, Celgene, Medac, Sanofi, Lilly, Hexal, Pfizer, Janssen, Roche, Schire, Onkowissen, Royal College London, Boehringer-Ingelheim, Rheumaakademie; consulting fees from Novartis, Chugai, AbbVie, Celgene, Sanofi, Lilly, Hexal, Pfizer, Amgen, BMS, Roche, Gilead, Medac, Boehringer-Ingelheim and research support from Novartis, Hexal, Lilly, Roche, Celgene, Universität Bonn, Boehringer-Ingelheim, BMBF. RN and LK have no conflict of interest to declare."

"Funding {4} Open Access funding enabled and organized by Projekt DEAL. This trial is an investigator-initiated trial (IIT) funded by the Medical Faculty of the Rheinische Friedrich-Wilhelms-University Bonn via the Commission of Clinical Studies. Partial financial support is provided by “MEDAC Gesellschaft für klinische Spezialpräparate mbH”."

"Trial registration ClinicalTrials.gov, NCT05623592. Registered on 21 November 2022. EU Clinical Trials Register, 2022-501058-12-00. German Clinical Trials Register DRKS00030571."