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Extended report
Tofacitinib in patients with ankylosing spondylitis: a phase II, 16-week, randomised, placebo-controlled, dose-ranging study
  1. Désirée van der Heijde1,
  2. Atul Deodhar2,
  3. James C Wei3,
  4. Edit Drescher4,
  5. Dona Fleishaker5,
  6. Thijs Hendrikx6,
  7. David Li6,
  8. Sujatha Menon5,
  9. Keith S Kanik5
  1. 1 Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands
  2. 2 Division of Arthritis and Rheumatic Diseases, Oregon Health & Science University, Portland, Oregon, USA
  3. 3 Division of Allergy, Immunology and Rheumatology, Chung Shan Medical University Hospital, Graduate Institute of Integrated Medicine, China Medical University, Taichung, Taiwan
  4. 4 Csolnoky Ferenc Hospital, Veszprém, Hungary
  5. 5 Pfizer Inc, Groton, Connecticut, USA
  6. 6 Pfizer Inc, Collegeville, Pennsylvania, USA
  1. Correspondence to Professor Désirée van der Heijde, Department of Rheumatology, Leiden University Medical Center, PO Box 9600, 2300 RC Leiden, The Netherlands; mail{at}dvanderheijde.nl

Footnotes

  • Handling editor Tore K Kvien

  • Contributors DvdH, DF, TH, KSK and SM contributed to the study design. DF, DvdH, DL, TH, SM and KSK contributed to data analysis. All authors contributed to data interpretation, and planning and critical review of the manuscript content. All authors were responsible for the final decision to submit. Medical writing support, under the direction of the authors, was provided by Amanda Pedder of Complete Medical Communications.

  • Funding This study was sponsored by Pfizer Inc. Medical writing support, under the direction of the authors, was provided by Amanda Pedder of Complete Medical Communications and funded by Pfizer Inc.

  • Competing interests DvdH is a consultant for AbbVie, Amgen, AstraZeneca, Augurex, BMS, Boehringer Ingelheim, Celgene, Centocor, Chugai, Covagen, Daiichi, Eli Lilly, Galapagos, GSK, Janssen Biologics, Merck, Novartis, Novo Nordisk, Otsuka, Pfizer, Roche, Sanofi-Aventis, UCB and Vertex; and is director of Imaging Rheumatology. AD has received research grants from AbbVie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer and UCB, and has been an advisory board member for AbbVie, Amgen, Boehringer Ingelheim, Janssen, Novartis, Pfizer and UCB. JCW has received research grants or consultation fees from AbbVie, BMS, Celgene, Chugai, Eisai, Janssen, Novartis, Pfizer, Sanofi-Aventis, TSH Taiwan and UCB. ED has participated in clinical trials sponsored by AbbVie, BMS, Celgene, Pfizer, Novartis, UCB, Amgen, Lilly and Sanofi-Aventis. KSK, DF, TH, DL and SM are employees and shareholders of Pfizer, Inc.

  • Ethics approval The study protocol and informed consent documentation were approved by institutional review boards or independent ethics committees at each investigational centre.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement All authors had full access to study data and had final responsibility for the decision to submit.

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Footnotes

  • Handling editor Tore K Kvien

  • Contributors DvdH, DF, TH, KSK and SM contributed to the study design. DF, DvdH, DL, TH, SM and KSK contributed to data analysis. All authors contributed to data interpretation, and planning and critical review of the manuscript content. All authors were responsible for the final decision to submit. Medical writing support, under the direction of the authors, was provided by Amanda Pedder of Complete Medical Communications.

  • Funding This study was sponsored by Pfizer Inc. Medical writing support, under the direction of the authors, was provided by Amanda Pedder of Complete Medical Communications and funded by Pfizer Inc.

  • Competing interests DvdH is a consultant for AbbVie, Amgen, AstraZeneca, Augurex, BMS, Boehringer Ingelheim, Celgene, Centocor, Chugai, Covagen, Daiichi, Eli Lilly, Galapagos, GSK, Janssen Biologics, Merck, Novartis, Novo Nordisk, Otsuka, Pfizer, Roche, Sanofi-Aventis, UCB and Vertex; and is director of Imaging Rheumatology. AD has received research grants from AbbVie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer and UCB, and has been an advisory board member for AbbVie, Amgen, Boehringer Ingelheim, Janssen, Novartis, Pfizer and UCB. JCW has received research grants or consultation fees from AbbVie, BMS, Celgene, Chugai, Eisai, Janssen, Novartis, Pfizer, Sanofi-Aventis, TSH Taiwan and UCB. ED has participated in clinical trials sponsored by AbbVie, BMS, Celgene, Pfizer, Novartis, UCB, Amgen, Lilly and Sanofi-Aventis. KSK, DF, TH, DL and SM are employees and shareholders of Pfizer, Inc.

  • Ethics approval The study protocol and informed consent documentation were approved by institutional review boards or independent ethics committees at each investigational centre.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement All authors had full access to study data and had final responsibility for the decision to submit.

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