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First Online: 23 September 2020

Declarations

:

: Open Access funding provided by Akershus University Hospital (AHUS). This work was supported by the Norwegian Ministry of Health and Care Services.

: <i>KKJ</i> reports personal fees from Intercept, Norgine, and Celltrion. <i>GLG</i> reports personal fees from AbbVie, Biogen, Eli Lilly, MSD, Novartis, Pfizer, Roche, Sandoz, Orion Pharma, Celltrion, and Boehringer Ingelheim. <i>NB</i> reports personal fees received from Orion Pharma, Roche, Napp Pharmaceuticals, Pfizer, and Takeda. <i>ICO</i> reports grants from the Norwegian Ministry of Health and Care Services during the conduct of the study and personal fees from Pfizer. <i>EAH</i> reports grants from AbbVie, Pfizer, UCB, Roche, and MSD. <i>IPB</i> reports personal fees from AbbVie, MSD, Takeda, Hospira, and Ferring. <i>KEAL</i> reports grants from MSD and personal fees from Takeda, Orion, AbbVie, Pfizer, and MSD. <i>JJ</i> reports personal fees from MSD, AbbVie, Celltrion, Orion Pharma, Takeda, Napp Pharm, AstroPharma, Hikma, and Pfizer. <i>TK</i> reports grants from the Norwegian Ministry of Health and Care Services during the conduct of the study and personal fees from AbbVie, Biogen, BMS, Boehringer Ingelheim, Celltrion, Eli Lilly, Epirus, Janssen, Merck-Serono, MSD, Mundipharma, Novartis, Oktal, Orion Pharma, Hospira/Pfizer, Roche, Sandoz, and UCB Pharma. <i>SOF</i> reports personal fees from Takeda, Pharmacosmos, Tillotts, Janssen, Intercept, and Pfizer. The remaining authors have no conflicts of interest to declare.

: The study protocol and consent documents were approved by an independent ethics committee (Regional Committees for Medical and Health Research Ethics South East; reference number 2014/848), by appropriate institutional review boards, and by the Norwegian Medicines Agency (reference number 14/07192-11). The study was conducted in compliance with the Declaration of Helsinki and the International Conference on Harmonization Guidelines for Good Clinical Practice. Trial registration numbers: ClinicalTrials.gov NCT-02148640, EudraCT Number: 2014-002056-40.

: All patients received verbal and written information about the study and signed an informed consent form.

: The corresponding author (KKJ) together with the statistician (JS) had full access to all the data in the study and had final responsibility for the decision to submit for publication. The study data are available on request from the authors.

: Statistical analyses were done in Stata version 14.1 and R 3.4.4. Key commands used in the statistical analyses are available upon request.

: <i>KKJ</i> contributed to study design, oversaw the implementation of the study at all centres, provided support to study personnel at each site during the study, contributed to data interpretation, and drafted and critically revised the manuscript. She took final responsibility for the decision to submit for publication. <i>JJ</i> contributed to study conception and design, interpreted data, and drafted and critically revised the manuscript. He has had full access to all the data in the study. <i>TK</i> was the principal investigator who conceived and designed the study, interpreted data, and drafted and critically revised the report. He has had full access to all the data in the study. <i>GLG</i> contributed to study design, contributed to data interpretation, and drafted and critically revised the manuscript. <i>JS</i> and <i>ICO</i> were the study statisticians. <i>JS</i> performed the analyses, contributed to data interpretation, and drafted and critically revised the manuscript. <i>ICO</i> contributed to study conception, helped design the study, led the development of the electronic CRF, and contributed support to all sites during the study. He contributed to data interpretation and drafted and critically revised the manuscript. <i>NB</i> helped design the study, facilitated laboratory analyses of infliximab and anti-drug antibodies, developed the assay for anti-drug antibodies, and planned and organised the study biobank. He helped interpret data and critically revised the manuscript. <i>KEAL</i> contributed to study conception and design, in particular, contributing to planning and interpretation of the immunogenicity analyses, and critically revised the manuscript. <i>EAH</i> contributed to study conception, helped design the study, helped interpret data, and critically revised the manuscript. <i>DJW</i> developed the assay for infliximab drug levels, provided reagents for anti-drug antibody analysis, was instrumental in setting up the infrastructure for these analyses, helped interpret data, and critically revised the report. <i>RK</i> performed the immunogenicity analyses, helped organise the study biobank, and critically revised the report. <i>ØA</i>, <i>IPB</i>, <i>IMB</i>, <i>KD</i>, <i>JF</i>, <i>SOF</i>, <i>MH</i>, <i>GHH</i>, <i>BM</i>, <i>GN</i>, <i>UP</i>, <i>JHR</i>, <i>LS</i>, <i>KAS</i>, <i>RT</i>, <i>CV</i>, and <i>CMY</i> were main investigators at each study site, who implemented the study at their site, collected data, and critically revised the report. <i>JH</i> was the user representative and contributed to the design of the trial, data collection from a service user perspective, was crucial in distributing study information to relevant patient populations, and critically revised the report. All authors made substantial contributions to the conception or design of the study, the acquisition, analysis or interpretation of the data; commented on drafts of this paper; and approved the final version. All authors agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.