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Current Endpoints of Clinical Trials in Ulcerative Colitis: Are They Valid?

Current Treatment Options in Gastroenterology volume 18, pages 15–32 (2020)Cite this article

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Authors and Affiliations

  1. Division of Gastroenterology and Hepatology, University of California San Diego, La Jolla, CA, USA

    Robert Battat MD, Parambir S. Dulai MD & William J Sandborn MD

  2. Robarts Clinical Trials, Inc., 100 Dundas Street, Suite, London, Ontario, Canada

    Robert Battat MD, Christopher Ma MD, Vipul Jairath MD, PhD, Brian G Feagan MD & William J Sandborn MD

  3. Division of Gastroenterology and Hepatology, University of Calgary, Calgary, Alberta, Canada

    Christopher Ma MD

  4. Department of Medicine, Division of Gastroenterology, University of Western Ontario, London, Ontario, Canada

    Vipul Jairath MD, PhD, Brian G Feagan MD & Reena Khanna MD

  5. Department of Epidemiology and Biostatistics, University of Western Ontario, London, Ontario, Canada

    Vipul Jairath MD, PhD & Brian G Feagan MD

Authors
  1. Robert Battat MD
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  2. Parambir S. Dulai MD
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  3. Christopher Ma MD
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  4. Vipul Jairath MD, PhD
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  5. Brian G Feagan MD
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  7. Reena Khanna MD
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Corresponding author

Correspondence to Reena Khanna MD.

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Conflict of Interest

Christopher Ma reports working as an academic research consultant for Robarts Clinical Trials, Inc., outside the submitted work.

Brian Feagan reports grants and personal fees from Abbvie, Amgen, Astra Zeneca, Bristol-Myers Squibb, Janssen Biotech/Centocor, JmJ/Janseen, Pfizer, Receptos, and Takeda; and personal fees from Avaxia Biologics, Atlantic Pharma, Baxter Healthcare Corporation, Biogen Idec, Boehringer,-Ingelheim, Calypso Biotech, Celgene, Elan/Biogen, EnGene, Ferring, Genetech/Roche, GiCare Pharma, Gilead, Given Imaging, GSK, Ironwood, Kyowa Kakko Kirin Co Ltd., Lilly, Lycera Biotech, Merck, Mesoblast Pharma, Millennium, Nestles, Novo Nordisk, Novartis, Prometheus Therapeutics and Diagnostics, Protagonist, Receptos, Salix, Shire, Sigmoid Pharma, Synergy Pharma, Teva Pharma, TiGenix, Tillotts, UCB, Vertex, VHsquared, Wyeth, Zealand, Zyngenia, Galapagos, Inception IBD INc., Lexicon, Vivelix Pharma, Japan Tobacco Company, Ablynx, Progenity, NextBiotix, Gossamer, Pharma, and Qu Biologics; and a grant from Sanofi.

Vipul Jairath declares personal fees from Abbvie, Takeda, Pfizer, Sandoz, Janssen, Arena Pharma, GSK, Eli Lilly, Ferring, Shire, Robarts Clinical Trials Inc., Genentech, Merck, Topivert, and Celltrion.

Reena Khanna reports personal fees from Abbvie, Janssen, Pfozer, Shire, Takeda, Encycle, Merck, Pendopharm, Roche, and Robarts Clinical Trials.

Robert Battat, Parambir S. Dulai, and William J Sandborn declare that they no conflict of interest.

Parambir S. Dulai reports other from Takeda, other from Janssen, other from Pfizer, other from Polymedco, other from Crohn's and Colitis Foundation, other from American College of Gastroenterology, personal fees from Takeda, personal fees from Janssen, personal fees from Pfizer, personal fees from Takeda, other from Takeda, other from Janssen, outside the submitted work.

WIlliam Sandborn reports grants and personal fees from Abbvie, personal fees from Allergan, grants and personal fees from Amgen, personal fees from Arena Pharmaceuticals, grants from Atlantic Pharmaceuticals, personal fees from Avexegen Therapeutics, personal fees from Biogen Idec, personal fees and other from BeiGene, personal fees from Boehringer Ingelheim, personal fees from Bristol Meyers Squibb, grants and personal fees from Celgene, personal fees from Celltrion, personal fees from Conatus, personal fees from Cosmo Technologies, personal fees and other from Escalier Biosciences, personal fees from Ferring Pharmaceuticals, personal fees from Forbion, personal fees from Forward Pharma, grants and personal fees from Genentech, grants and personal fees from Gilead Sciences, personal fees and other from Gossamer Bio, personal fees from Immune Pharmaceuticals, personal fees from Incyte, grants and personal fees from Janssen, personal fees from Kyowa Hakko Kirin Pharma, personal fees from Landos Biopharma, grants and personal fees from Lilly, personal fees from Miraca Life Sciences, personal fees from Nivalis Therapeutics, personal fees from Novartis, personal fees from Nutrition Science Partners, personal fees and other from Oppilan Pharma, personal fees from Otsuka, personal fees from Paul Hastings, grants and personal fees from Pfizer, personal fees and other from Precision IBD, personal fees and other from Progenity, grants and personal fees from Prometheus Laboratories, personal fees from Reistone, personal fees and other from Ritter Pharmaceuticals, grants and personal fees from Robarts Clinical Trials (owned by Health Academic Research Trust or HART), grants and personal fees from Salix Pharmaceuticals, personal fees from Series Therapeutics, grants and personal fees from Shire, personal fees from Sienna Biopharmaceuticals, personal fees from Sigmoid Biotechnologies, personal fees from Sterna Biologicals, personal fees from Sublimity Therapeutics, grants and personal fees from Takeda, personal fees from Theravance Biopharma, personal fees from Tigenix, personal fees from Tillotts Pharma, personal fees from UCB Pharma, other from Ventyx Biosciences, personal fees and other from Vimalan Biosciences, personal fees from Vivelix Pharmaceuticals, outside the submitted work; and Spouse: Opthotech - consultant, stock options; Progenity - consultant, stock; Oppilan Pharma - employee, stock options; Escalier Biosciences - employee, stock options; Precision IBD - employee, stock options; Ventyx Biosciences – employee, stock options; Vimalan Biosciences – employee, stock options.

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This article is part of the Topical Collection on Inflammatory Bowel Disease

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Battat, R., Dulai, P.S., Ma, C. et al. Current Endpoints of Clinical Trials in Ulcerative Colitis: Are They Valid?. Curr Treat Options Gastro 18, 15–32 (2020). https://doi.org/10.1007/s11938-019-00259-w

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Keywords

  • Ulcerative colitis
  • Clinical trial
  • Remission
  • Endpoints
  • Outcomes