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Article History

Received: 1 August 2018

Accepted: 19 November 2018

First Online: 8 January 2019

Ethics approval and consent to participate

: The trial was performed according to the study protocol and protocol amendments, which were approved by the Ethics Committee for Clinical Research of the participating sites and by the Spanish Agency for Medicines and Health Products, and complied with the ethical principles of biomedical research, Good Clinical Practice [] and applicable Spanish legislation. Two amendments to the protocol reflected in the clinical trial registration sites were implemented after recruitment was initiated, which referred to inclusion of new investigators and recruiting sites, and to allow collection of blood samples for measurement of inflammatory mediators, drug plasma measurements and ADA.

: All authors have read and approved the final version and consent to publication.

: No author has received any private funding, nor has any been influenced in the preparation of the manuscript. The following authors declare that they have no competing interests: CP, FT, CAS, AV and GC. In the past 2 years, JG has received grants to attend congresses and educational courses, has obtained fees for scientific consultancies and has received speaking fees and fees for participation in educational programmes from the following companies: Roche, MSD, Pfizer, AbbVie, Janssen Cilag, UCB Pharma, Novartis and Celgene. EdM has received grant/research support from AbbVie and Pfizer, honorarium as a speaker from Abbvie, MSD and Novartis and consultant fees from Abbvie and Novartis. JS has obtained grants to attend congresses, speaking fees and fees for participation in educational programmes from Abbvie, Pfizer, MSD, Roche, UCB and Menarini. XJ has attended advisory board meetings of Celgene, has received investigational grants from Abbvie and Pfizer and has received fees for participation in educational programmes from MSD, Pfizer and Abbvie. RS has received speaking fees and fees for attending advisory boards from Abbott/Abbvie, Bristol-Myers Squibb, MSD, Roche, UCB and Pfizer, investigational grants from Bristol-Myers Squibb, MSD, Roche, UCB, Pfizer, FER and SCR and funding for educational projects from MSD, Bristol-Myers Squibb and Abbvie.

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