Muehler, Andreas
Kohlhof, Hella
Groeppel, Manfred
Vitt, Daniel
Clinical trials referenced in this document:
Documents that mention this clinical trial
The Selective Oral Immunomodulator Vidofludimus in Patients with Active Rheumatoid Arthritis: Safety Results from the COMPONENT Study
https://doi.org/10.1007/s40268-019-00286-z
Article History
First Online: 16 October 2019
Compliance with Ethical Standards
:
: The COMPONENT study was funded by 4SC AG, the original developer of vidofludimus.
: All authors had full access to the study data, were involved in data interpretation, participated in manuscript preparation, and approved the final version for submission.
: Hella Kohlhof, Manfred Groeppel, and Daniel Vitt were all employed by 4SC AG, the study sponsor, during the time the COMPONENT study was conducted. All authors are current employees of, and hold stock in, Immunic AG, which owns the rights to vidofludimus at this time. All authors are co-inventors for patents or patent applications covering vidofludimus.
: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. This study received ethical approval from the Institutional Review Board or independent Ethics Committee at each site, and was approved by national regulatory agencies. Written informed consent was obtained from all participants prior to enrollment in the study.