Channick, Richard http://orcid.org/0000-0002-9016-4468
Chin, Kelly M.
McLaughlin, Vallerie V.
Lammi, Matthew R.
Zamanian, Roham T.
Turricchia, Stefano
Ong, Rose
Mitchell, Lada
Kim, Nick H.
Clinical trials referenced in this document:
Documents that mention this clinical trial
Macitentan in Pulmonary Arterial Hypertension Associated with Connective Tissue Disease (CTD-PAH): Real-World Evidence from the Combined OPUS/OrPHeUS Dataset
https://doi.org/10.1007/s40119-024-00361-w
Documents that mention this clinical trial
Macitentan in Pulmonary Arterial Hypertension Associated with Connective Tissue Disease (CTD-PAH): Real-World Evidence from the Combined OPUS/OrPHeUS Dataset
https://doi.org/10.1007/s40119-024-00361-w
Funding for this research was provided by:
Actelion Pharmaceuticals Ltd, a Janssen Pharmaceutical Company of Johnson and Johnson
Article History
Received: 10 December 2023
Accepted: 14 February 2024
First Online: 7 March 2024
Declarations
:
: Richard Channick served as a scientific committee member for Janssen Pharmaceutical Companies of Johnson & Johnson; served on an advisory board for Janssen Pharmaceutical Companies of Johnson & Johnson and Bayer; received research grants / support from Janssen Pharmaceutical Companies of Johnson & Johnson and United therapeutics; received speaker fees from Janssen Pharmaceutical Companies of Johnson & Johnson, and Bayer; received consultancy fees from Janssen Pharmaceutical Companies of Johnson & Johnson, Bayer and Third pole. Kelly M Chin has served as a scientific committee member for Janssen Pharmaceutical Companies of Johnson & Johnson; has received research grants / support from Janssen Pharmaceutical Companies of Johnson & Johnson, Altavant, Acceleron, United Therapeutics, Pfizer, Merck, Gossamer Bio; has received support for travel to meetings from Janssen Pharmaceutical Companies of Johnson & Johnson; and has received consultancy fees from Janssen Pharmaceutical Companies of Johnson & Johnson, Altavant, Acceleron, United Therapeutics, Gossamer Bio and Merck. Vallerie V McLaughlin served as a scientific committee member from Janssen Pharmaceutical Companies of Johnson & Johnson; received research grants from Aerovate, Altavant, Gossamer Bio, Janssen Pharmaceutical Companies of Johnson & Johnson, Merck, and SoniVie; and received consultant fees from Aerami, Aerovate, Altavant, Bayer, Caremark, Corvista, Gossamer Bio, Janssen Pharmaceutical Companies of Johnson & Johnson, L.L.C, Merck and United Therapeutics. Matthew R Lammi has received research grants / support from Janssen Pharmaceutical Companies of Johnson & Johnson, Gilead, Bayer, United Therapeutics, Altavant and Acceleron. Roham T Zamanian is a patent holder (FK-506 in PAH); has served as a scientific medical advisor for Morphogenic-IX; has received consulting fees from Vivus, Pfizer, and Selten; and has received grants / support from Janssen Pharmaceutical Companies of Johnson & Johnson and United Therapeutics. Stefano Turricchia and Lada Mitchell are employees of Janssen Pharmaceutical Companies of Johnson & Johnson. Rose Ong is an employee of Janssen Pharmaceutical Companies of Johnson & Johnson; has received support for travel to meetings from Janssen Pharmaceutical Companies of Johnson & Johnson; holds stock or stock options with Janssen Pharmaceutical Companies of Johnson & Johnson; and spouse is an employee of Roche. Nick H Kim has served a scientific committee member for Janssen Pharmaceutical Companies of Johnson & Johnson; has received research grants / support from Janssen Pharmaceutical Companies of Johnson & Johnson, Bellerophon, Eiger, Gossamer Bio, Lung Biotechnology, SoniVie, and Altavant; has received consultant fees from Bayer, Merck, United Therapeutics, Pulnovo, and Polarean; and speaker fees from Janssen Pharmaceutical Companies of Johnson & Johnson and Bayer.
: OPUS and OrPHeUS were executed in accordance with Good Pharmacoepidemiology Practices [] and the 2008 Declaration of Helsinki ethical principles. Ethical approval was received from independent ethics committees/institutional review boards of participating centers (Supplementary Material I). The protocols were reviewed by the US FDA with written informed consent obtained from all patients in OPUS (informed consent was not required in OrPHeUS as an Institutional Review Board (IRB) waiver was obtained). OPUS’ Informed Consent Form included a confidentiality clause that all records and documents pertaining to the participation of patients in the OPUS registry would be held strictly confidential and their names would not be reported in any publications resulting from the OPUS registry. IRB approvals were provided by the Western IRB and Quorum (now Advarra) (OPUS registry; Western IRB approval number 2014‐0816, Quorum Review File number 29120/Advarra Pro00035124) and WCG‐IRB (OrPHeUS study; IRB numbers 2017‐8051 and 2017‐2348).