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Article History

Received: 23 June 2020

Accepted: 6 August 2021

First Online: 17 August 2021

Declarations

:

: Before initiating the trial, each study center has to obtain a favorable opinion from the Institutional Review Board/Independent Ethics Committee for the trial protocol, informed consent form, and patient recruitment procedures.The informed consent complies with the ICH GCP guideline and regulatory requirements. Eligible patients may only be included in the study after providing informed consent.Any change or addition to the protocol can only be made in a written protocol amendment that must be approved by the sponsor, by the health authorities where required, and the Institutional Review Board/Independent Ethics Committee prior to implementation. Only amendments that are intended to eliminate an apparent immediate hazard to patients may be implemented immediately provided the health authorities are subsequently notified by protocol amendment and the reviewing Institutional Review Board/Independent Ethics Committee is notified.The Deutsche Rheuma-Liga Bundesverband e.V., the largest patient advocacy group for patients in Germany in the health sector, was consulted during the preparation of the study. Recommendations and input were collected with regard to patients’ perspective, patient information material as well as the trial specific patient diary on concomitant medication and the informed consent forms.

: Not applicable.

: C. Legeler, C. App, and C. Sieder are employees of Novartis Pharma GmbH.C. Jentzsch is an employee of Novartis Pharma AG.P. Lamprecht received consulting fees from Chugai and Janssen. He received speaker’s honorarium from AbbVie, BMS, Chugai, GSK, Janssen, Novartis, and UCB.W.A. Schmidt received consulting fees from Chugai, GSK, Novartis, Roche, and Sanofi. He is a member of the Speaker’s Bureau of Chugai, Novartis, Roche, and Sanofi. He is/was the Principle Investigator in trials/studies from GSK, Novartis, Roche, and Sanofi.J. Thiel received consulting fees from AbbVie, BMS, GSK, Roche, and Novartis; speaker’s honorarium from AbbVie and BMS; and was Principle Investigator for a BMS study.H.-P. Tony was consultant for AbbVie, Amgen, BMS, Celgene, Chugai, Gilead, Janssen, Lilly, Novartis, Pfizer, Roche, and Sanofi.N. Venhoff received consulting fees from AbbVie, BMS, Celgene, Chugai, Novartis, Roche, and UCB and speakers honorarium from AbbVie, BMS, Chugai, Medac, Novartis, Pfizer, Roche, and UCB and is/was the Principle Investigator in studies from Novartis.