Gladman, Dafna D.
Orbai, Ana-Maria
Klitz, Uta
Wei, James Cheng-Chung
Gallo, Gaia
Birt, Julie
Rathmann, Suchitrita
Shrom, David
Marzo-Ortega, Helena
Funding for this research was provided by:
Eli Lilly and Company (n/a)
Article History
Received: 23 August 2018
Accepted: 18 January 2019
First Online: 29 January 2019
Ethics approval
: SPIRIT-P1 and SPIRIT-P2 were conducted in accordance with Good Clinical Practice, the principles of the Declaration of Helsinki, and local laws and regulations. Both SPIRIT-P1 and SPIRIT-P2 were registered at. SPIRIT-P1 was registered as NCT01695239 on 25-September-2012 (); SPIRIT-P2 was registered as NCT02349295 on 10-October-2014 ().SPIRIT-P1 was approved by the Western Institutional Review Board (approval #1-838258-1) and SPIRIT-P2 was approved by the Bellberry Human Research Ethics Committee (Application #2015-01-049-AA). For both studies, approval was also obtained from each additional site. All patients in both studies gave written informed consent.
: Not applicable
: D. D. Gladman is a consultant for AbbVie, Amgen, BMS, Celgene, Eli Lilly and Company, Janssen, Novartis, Pfizer, and UCB, and has received grant/research support from AbbVie, Amgen, Celgene, Eli Lilly and Company, Janssen, Novartis, Pfizer, and UCB.A.-M. Orbai is a consultant for Eli Lilly and Company, Novartis, and has received grant/research support from AbbVie, Celgene, Eli Lilly and Company, Horizon, Janssen, and Novartis.U. Kiltz has received grant and research support and consultancy fees from AbbVie, Biogen, Chugai, GrĂ¼nenthal, Janssen, MSD, Novartis, Pfizer, Roche, and UCB.J.C.-C. Wei has been consulted for Pfizer, Celgene, Chugai, UCB, and TSH (Taiwan); has received research grants from BMS, Janssen, Pfizer, Sanofi-Aventis, and Novartis; and has served on speakers bureaus for Abbott, BMS, Chugai, Eisai, Janssen, and Pfizer.H. Marzo-Ortega has received grant/research support from Janssen and is on the speaker bureau for AbbVie, Celgene, Janssen, MSD, Novartis, Pfizer, and UCB.G. Gallo, J. Birt, S. Rathmann, and D. Shrom are current employees and minor shareholders of Eli Lilly and Company.
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