Gastroenterology
Volume 135, Issue 2 , Pages 400-409, August 2008

A Randomized, Double-Blind, Sham-Controlled Study of Granulocyte/Monocyte Apheresis for Active Ulcerative Colitis

  • Bruce E. Sands

      Affiliations

    • MGH Crohn's & Colitis Center and Gastrointestinal Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts
    • Corresponding Author InformationAddress requests for reprints to: Bruce E. Sands, MD, MS, MGH Crohn's & Colitis Center, 165 Cambridge St, 9th Floor, Boston, Massachusetts 02114. fax: 617-726-5366.
    • ,
  • William J. Sandborn

      Affiliations

    • Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine, Rochester, Minnesota
    • ,
  • Brian Feagan

      Affiliations

    • Departments of Medicine, Epidemiology, and Biostatistics, University of Western Ontario, London, Ontario, Canada
    • Robarts Research Institute, University of Western Ontario, London, Ontario, Canada
    • ,
  • Robert Löfberg

      Affiliations

    • IBD Unit at Sophiahemmet and Karolinska Institute, Stockholm, Sweden
    • ,
  • Toshifumi Hibi

      Affiliations

    • Division of Gastroenterology, Department of Internal Medicine, Keio University School of Medicine, Keio, Japan
    • ,
  • Tao Wang

      Affiliations

    • Otsuka America Pharmaceutical, Inc, Rockville, Maryland
    • ,
  • Lisa–Marie Gustofson

      Affiliations

    • Otsuka America Pharmaceutical, Inc, Rockville, Maryland
    • ,
  • Cindy J. Wong

      Affiliations

    • Robarts Research Institute, University of Western Ontario, London, Ontario, Canada
    • ,
  • Margaret K. Vandervoort

      Affiliations

    • Robarts Research Institute, University of Western Ontario, London, Ontario, Canada
    • ,
  • Stephen Hanauer

      Affiliations

    • Section of Gastroenterology, Hepatology, and Nutrition, University of Chicago, Chicago, Illinois
    • ,
  • Adacolumn Study Group

Received 14 January 2008; accepted 10 April 2008. published online 28 April 2008.

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 Supported by Otsuka America Pharmaceutical Inc.

 Conflicts of interest: The authors disclose the following relationships: Bruce E. Sands: grant or research support from Cerimon, Bristol-Myers Squibb, Centocor, Abbott Immunology, Prometheus Laboratories, Shire Pharmaceuticals, Protein Design Laboratories Biopharma, Otsuka America Pharmaceutical Inc, Procter & Gamble Pharmaceuticals; consultant for Axcan, Cerimon, Bristol-Myers Squibb, Centocor, Abbott Immunology, Prometheus Laboratories, Shire Pharmaceuticals, Protein Design Laboratories Biopharma, Otsuka America Pharmaceutical Inc, Procter & Gamble Pharmaceuticals; member of scientific advisory boards of Cerimon, Bristol-Squibb, Centocor, Abbott Immunology, Prometheus Laboratories, Shire Pharmaceuticals, Protein Design Laboratories Biopharma, Otsuka America Pharmaceutical Inc, Procter & Gamble Pharmaceuticals. William J. Sandborn: grant or research support from JIMRO/Otsuka Pharmaceuticals America Inc; consultant for JIMRO/Otsuka America Pharmaceuticals Inc. Brian Feagan: grant or research support from Schering-Plough, Otsuka, Milllennium, Tillotts, Abbott, Protein Design Labs, Boehringer Engelheim, Novartis, Centocor, Berlex, Synta, Schering Canada, Elan/Biogen, UCB Pharma, BMS, Proctor & Gamble, Napo Pharma; consultant for Synta, Millennium, Schering Canada, Celltech, Centocor, Elan/Biogen, Janssen-Ortho, Protein Design Labs, ISIS, Teva Pharmaceuticals, Santarus, Schering Plough, Bristol-Myers Squibb, Celgene, Combinatorx, UCB Pharma, Napo Pharma, Abbott, Proctor & Gamble, Osiris, Berlex, AstraZeneca, GeneLogic Inc, Cerimon Pharm, Tioga Pharm, Serono, Genentech; member of the Speakers Bureau of AstraZeneca; member of the scientific advisory boards of Protein Design Labs, AstraZeneca, Elan/Biogen, Celltech, Synta, Schering Canada, Celgene. Robert Löfberg: grant or research support from Abbott Labs, Asahi, AstraZeneca, Celltech, Centocor, Elan, Ferring, InDex Pharmaceuticals, Meda, Otsuka Frankfurt Research Institute, Otsuka Pharmaceuticals Scandinavia, Pharmacia, Pfizer, Schering Plough, UCB; member of scientific advisory boards of Abbott Labs, Asahi, AstraZeneca, Celltech, Centocor, Connexion, Cosmo, Elan, InDex Pharmaceuticals, Meda, Novartis, Otsuka Frankfurt Research Institute, Pharmacia, Pfizer, Schering Plough, Schering AG, Serono, Therakos, UCB. Toshifumi Hibi: grant or research support from Abbott Japan, Ajinomoto Pharma, Asahi Kasei Kuraray Medical, AstraZeneca Pharmaceuticals, Janssen Pharmaceutical K. K., JIMRO, Nisshin Kyorin Pharmaceutical Company, Otsuka Pharma, Tanabe Mitsubishi Seiyaku, UCB Japan, UMN Pharma, Zeria Pharmaceutical. Lisa-Marie Gustafson and Tao Wang are employees of Otsuka America Pharmaceutical Inc.

 Editorial assistance was provided by Judy Andraski, PhD, and Adelphi Inc, as funded by Otsuka America Pharmaceutical Inc, and by Tina Wright, an employee of Otsuka America Pharmaceutical Inc.

 The investigators disclosed potential conflicts to study participants.

 The statistical analysis of the entire data sets pertaining to efficacy and safety has been independently confirmed by Cindy Wong of Robarts Research Institute. Cindy Wong and Margaret Vandervoort are employees of Robarts Research Institute.

 Dr Sands had full access to all of the data and takes full responsibility for the veracity of the data and analysis.

 Role of the sponsor: The studies were designed by the sponsors, Otsuka America Pharmaceuticals, Inc, and Otsuka Frankfurt Research Institute, GmbH, respectively, in collaboration with the investigators. Trial execution was supervised by the sponsors in collaboration with the investigators and the contract research organizations (Robarts Clinical Trials for the pivotal study and PAREXEL International for the companion study). Data analysis for both studies was performed by Robarts Clinical Trials in collaboration with the sponsors and investigators.

PII: S0016-5085(08)00693-8

doi:10.1053/j.gastro.2008.04.023

Refers to article:

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    Gastroenterology August 2008 (Vol. 135, Issue 2, Page 699)

Gastroenterology
Volume 135, Issue 2 , Pages 400-409, August 2008

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