Efficacy and safety of granulocyte, monocyte/macrophage adsorptive in pediatric ulcerative colitis
Tarja Ruuska, Department of Pediatrics, Tampere University Hospital, 33521 Tampere, Finland
Peter Küster, Department of Pediatrics and Adolescent Medicine, Clemenshospital, 48153 Münster, Germany
Lena Grahnquist, Karolinska University Hospital, Astrid Lindgren Children’s Hospital, 17176 Solna, Sweden
Fredrik Lindgren, Department of Pediatrics, Karolinska University Hospital, Huddinge, 14186 Stockholm, Sweden
Anne Vibeke Wewer, Department of Pediatrics, Hvidovre Hospital, 2650 Hvidovre, Denmark
Author contributions: All the authors contributed equally to this work and were equally involved in revisions of the manuscript; Ruuska T, Küster P, Lindgren F and Wewer AV approved the final manuscript.
Supported by Otsuka Frankfurt Research Institute, the legal and financial sponsor for this clinical trial, Otsuka Pharmaceutical Europe Ltd. supported the realization of this paper.
Institutional review board statement: The ADAPT study was reviewed and approved as per Attachment 62, No.18/2008, by the Joint Municipal Authority for Medical Services of Pirkanmaa, Tampere, Finland.
Clinical trial registration statement: The ADAPT study is registered at www.ClinicalTrials.gov (identifier: NCT00781638).
Informed consent statement: This investigation was conducted in accordance with GCP, the Declaration of Helsinki and EN ISO 14155:2003. All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: All authors have received fees and honoraries for consultancy as an advisory board member and as investigator of the ADAPT trial from Otsuka Frankfurt Research Institute.
Data sharing statement: No additional data are available.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Tarja Ruuska, MD, Department of Pediatrics, Tampere University Hospital, 33521 Tampere, Finland. email@example.com
Telephone: +358-3-31164538 Fax: +358-3-31165655
Received: December 1, 2015
Peer-review started: December 4, 2015
First decision: December 31, 2015
Revised: February 15, 2016
Accepted: March 2, 2016
Article in press: March 2, 2016
Published online: May 7, 2016