title: Toreforant, A Histamine H4 Receptor Antagonist, in Patients with Active Rheumatoid Arthritis Despite Methotrexate Therapy: Results of 2 Phase II Studies.
abstract: To assess toreforant (selective histamine H4 receptor antagonist) in active rheumatoid arthritis (RA).
  
  
  
  In a phase IIa, double-blind, placebo-controlled test, 86 patients were randomized (2:1) to once-daily toreforant 100 mg or placebo for 12 weeks. In phase IIb, double-blind, placebo-controlled, dose-range-finding evaluations, 272 patients were randomized (1:1:1:1) to once-daily placebo or toreforant 3/10/30 mg. Primary efficacy endpoints for both studies were Week 12 changes in 28-joint Disease Activity Score-C-reactive protein (DAS28-CRP).
  
  
  
  Phase IIa testing was terminated prematurely (patient fatality; secondary hemophagocytic lymphohistiocytosis). Posthoc analyses indicated toreforant 100 mg/day reduced RA signs/symptoms through Week 12. Phase IIb testing, however, showed no significant Week 12 improvement in DAS28-CRP with toreforant.
  
  
  
  Toreforant was not effective in phase IIb testing.
authors.affiliation: From the Immunology department, Janssen Research & Development, LLC, San Diego, California; the Medical Affairs department, Janssen Research & Development, LLC, Horsham, Pennsylvania; the Biostatistics department and the Immunology department, Janssen Research & Development, LLC, Spring House, Pennsylvania, USA; Early Development, Janssen China Research and Development, Shanghai, China; the Biostatistics department, Janssen Research & Development, LLC, Belmont, Massachusetts, USA; Rheumatology Department, M&M Centers LTD., Adazi, Latvia; Immunology Department, University of Rochester, Rochester, New York, USA; Internal Medicine, University of Occupational and Environmental Health, Kitakyushu; Rheumatology, Keio University Hospital, Tokyo, Japan; Rheumatology, Medical University of Vienna and Hietzing Hospital, Vienna, Austria.R.L. Thurmond, PhD, Immunology Department, Janssen Research & Development, LLC; A. Greenspan, MD, Medical Affairs Department, Janssen Research & Development, LLC; W. Radziszewski, MD, PhD, Immunology Department, Janssen Research & Development, LLC; X.L. Xu, PhD, Immunology Department, Janssen Research & Development, LLC; Y. Miao, MS, Biostatistics Department, Janssen Research & Development, LLC; B. Chen, PhD, Early Development, Janssen China Research and Development; T. Ge, PhD, Biostatistics Department, Janssen Research & Development, LLC; B. Zhou, PhD, Biostatistics, Janssen Research & Development, LLC; D.G. Baker, MD, Immunology Department, Janssen Research & Development, LLC; D. Pavlova, MD, Rheumatology, M&M Centers Ltd.; C.T. Ritchlin, MD, Immunology Department, University of Rochester; Y. Tanaka, MD, PhD, Internal Medicine, University of Occupational and Environmental Health; T. Takeuchi, MD, PhD, Rheumatology, Keio University Hospital; J.S. Smolen, MD, Rheumatology, Medical University of Vienna and Hietzing Hospital. RThurmon@its.jnj.com.
authors.forename: Robin L
authors.initials: RL
authors.lastname: Thurmond
authors.affiliation: From the Immunology department, Janssen Research & Development, LLC, San Diego, California; the Medical Affairs department, Janssen Research & Development, LLC, Horsham, Pennsylvania; the Biostatistics department and the Immunology department, Janssen Research & Development, LLC, Spring House, Pennsylvania, USA; Early Development, Janssen China Research and Development, Shanghai, China; the Biostatistics department, Janssen Research & Development, LLC, Belmont, Massachusetts, USA; Rheumatology Department, M&M Centers LTD., Adazi, Latvia; Immunology Department, University of Rochester, Rochester, New York, USA; Internal Medicine, University of Occupational and Environmental Health, Kitakyushu; Rheumatology, Keio University Hospital, Tokyo, Japan; Rheumatology, Medical University of Vienna and Hietzing Hospital, Vienna, Austria.R.L. Thurmond, PhD, Immunology Department, Janssen Research & Development, LLC; A. Greenspan, MD, Medical Affairs Department, Janssen Research & Development, LLC; W. Radziszewski, MD, PhD, Immunology Department, Janssen Research & Development, LLC; X.L. Xu, PhD, Immunology Department, Janssen Research & Development, LLC; Y. Miao, MS, Biostatistics Department, Janssen Research & Development, LLC; B. Chen, PhD, Early Development, Janssen China Research and Development; T. Ge, PhD, Biostatistics Department, Janssen Research & Development, LLC; B. Zhou, PhD, Biostatistics, Janssen Research & Development, LLC; D.G. Baker, MD, Immunology Department, Janssen Research & Development, LLC; D. Pavlova, MD, Rheumatology, M&M Centers Ltd.; C.T. Ritchlin, MD, Immunology Department, University of Rochester; Y. Tanaka, MD, PhD, Internal Medicine, University of Occupational and Environmental Health; T. Takeuchi, MD, PhD, Rheumatology, Keio University Hospital; J.S. Smolen, MD, Rheumatology, Medical University of Vienna and Hietzing Hospital.
authors.forename: Andrew
authors.initials: A
authors.lastname: Greenspan
authors.affiliation: From the Immunology department, Janssen Research & Development, LLC, San Diego, California; the Medical Affairs department, Janssen Research & Development, LLC, Horsham, Pennsylvania; the Biostatistics department and the Immunology department, Janssen Research & Development, LLC, Spring House, Pennsylvania, USA; Early Development, Janssen China Research and Development, Shanghai, China; the Biostatistics department, Janssen Research & Development, LLC, Belmont, Massachusetts, USA; Rheumatology Department, M&M Centers LTD., Adazi, Latvia; Immunology Department, University of Rochester, Rochester, New York, USA; Internal Medicine, University of Occupational and Environmental Health, Kitakyushu; Rheumatology, Keio University Hospital, Tokyo, Japan; Rheumatology, Medical University of Vienna and Hietzing Hospital, Vienna, Austria.R.L. Thurmond, PhD, Immunology Department, Janssen Research & Development, LLC; A. Greenspan, MD, Medical Affairs Department, Janssen Research & Development, LLC; W. Radziszewski, MD, PhD, Immunology Department, Janssen Research & Development, LLC; X.L. Xu, PhD, Immunology Department, Janssen Research & Development, LLC; Y. Miao, MS, Biostatistics Department, Janssen Research & Development, LLC; B. Chen, PhD, Early Development, Janssen China Research and Development; T. Ge, PhD, Biostatistics Department, Janssen Research & Development, LLC; B. Zhou, PhD, Biostatistics, Janssen Research & Development, LLC; D.G. Baker, MD, Immunology Department, Janssen Research & Development, LLC; D. Pavlova, MD, Rheumatology, M&M Centers Ltd.; C.T. Ritchlin, MD, Immunology Department, University of Rochester; Y. Tanaka, MD, PhD, Internal Medicine, University of Occupational and Environmental Health; T. Takeuchi, MD, PhD, Rheumatology, Keio University Hospital; J.S. Smolen, MD, Rheumatology, Medical University of Vienna and Hietzing Hospital.
authors.forename: Waldemar
authors.initials: W
authors.lastname: Radziszewski
authors.affiliation: From the Immunology department, Janssen Research & Development, LLC, San Diego, California; the Medical Affairs department, Janssen Research & Development, LLC, Horsham, Pennsylvania; the Biostatistics department and the Immunology department, Janssen Research & Development, LLC, Spring House, Pennsylvania, USA; Early Development, Janssen China Research and Development, Shanghai, China; the Biostatistics department, Janssen Research & Development, LLC, Belmont, Massachusetts, USA; Rheumatology Department, M&M Centers LTD., Adazi, Latvia; Immunology Department, University of Rochester, Rochester, New York, USA; Internal Medicine, University of Occupational and Environmental Health, Kitakyushu; Rheumatology, Keio University Hospital, Tokyo, Japan; Rheumatology, Medical University of Vienna and Hietzing Hospital, Vienna, Austria.R.L. Thurmond, PhD, Immunology Department, Janssen Research & Development, LLC; A. Greenspan, MD, Medical Affairs Department, Janssen Research & Development, LLC; W. Radziszewski, MD, PhD, Immunology Department, Janssen Research & Development, LLC; X.L. Xu, PhD, Immunology Department, Janssen Research & Development, LLC; Y. Miao, MS, Biostatistics Department, Janssen Research & Development, LLC; B. Chen, PhD, Early Development, Janssen China Research and Development; T. Ge, PhD, Biostatistics Department, Janssen Research & Development, LLC; B. Zhou, PhD, Biostatistics, Janssen Research & Development, LLC; D.G. Baker, MD, Immunology Department, Janssen Research & Development, LLC; D. Pavlova, MD, Rheumatology, M&M Centers Ltd.; C.T. Ritchlin, MD, Immunology Department, University of Rochester; Y. Tanaka, MD, PhD, Internal Medicine, University of Occupational and Environmental Health; T. Takeuchi, MD, PhD, Rheumatology, Keio University Hospital; J.S. Smolen, MD, Rheumatology, Medical University of Vienna and Hietzing Hospital.
authors.forename: Xie L
authors.initials: XL
authors.lastname: Xu
authors.affiliation: From the Immunology department, Janssen Research & Development, LLC, San Diego, California; the Medical Affairs department, Janssen Research & Development, LLC, Horsham, Pennsylvania; the Biostatistics department and the Immunology department, Janssen Research & Development, LLC, Spring House, Pennsylvania, USA; Early Development, Janssen China Research and Development, Shanghai, China; the Biostatistics department, Janssen Research & Development, LLC, Belmont, Massachusetts, USA; Rheumatology Department, M&M Centers LTD., Adazi, Latvia; Immunology Department, University of Rochester, Rochester, New York, USA; Internal Medicine, University of Occupational and Environmental Health, Kitakyushu; Rheumatology, Keio University Hospital, Tokyo, Japan; Rheumatology, Medical University of Vienna and Hietzing Hospital, Vienna, Austria.R.L. Thurmond, PhD, Immunology Department, Janssen Research & Development, LLC; A. Greenspan, MD, Medical Affairs Department, Janssen Research & Development, LLC; W. Radziszewski, MD, PhD, Immunology Department, Janssen Research & Development, LLC; X.L. Xu, PhD, Immunology Department, Janssen Research & Development, LLC; Y. Miao, MS, Biostatistics Department, Janssen Research & Development, LLC; B. Chen, PhD, Early Development, Janssen China Research and Development; T. Ge, PhD, Biostatistics Department, Janssen Research & Development, LLC; B. Zhou, PhD, Biostatistics, Janssen Research & Development, LLC; D.G. Baker, MD, Immunology Department, Janssen Research & Development, LLC; D. Pavlova, MD, Rheumatology, M&M Centers Ltd.; C.T. Ritchlin, MD, Immunology Department, University of Rochester; Y. Tanaka, MD, PhD, Internal Medicine, University of Occupational and Environmental Health; T. Takeuchi, MD, PhD, Rheumatology, Keio University Hospital; J.S. Smolen, MD, Rheumatology, Medical University of Vienna and Hietzing Hospital.
authors.forename: Ye
authors.initials: Y
authors.lastname: Miao
authors.affiliation: From the Immunology department, Janssen Research & Development, LLC, San Diego, California; the Medical Affairs department, Janssen Research & Development, LLC, Horsham, Pennsylvania; the Biostatistics department and the Immunology department, Janssen Research & Development, LLC, Spring House, Pennsylvania, USA; Early Development, Janssen China Research and Development, Shanghai, China; the Biostatistics department, Janssen Research & Development, LLC, Belmont, Massachusetts, USA; Rheumatology Department, M&M Centers LTD., Adazi, Latvia; Immunology Department, University of Rochester, Rochester, New York, USA; Internal Medicine, University of Occupational and Environmental Health, Kitakyushu; Rheumatology, Keio University Hospital, Tokyo, Japan; Rheumatology, Medical University of Vienna and Hietzing Hospital, Vienna, Austria.R.L. Thurmond, PhD, Immunology Department, Janssen Research & Development, LLC; A. Greenspan, MD, Medical Affairs Department, Janssen Research & Development, LLC; W. Radziszewski, MD, PhD, Immunology Department, Janssen Research & Development, LLC; X.L. Xu, PhD, Immunology Department, Janssen Research & Development, LLC; Y. Miao, MS, Biostatistics Department, Janssen Research & Development, LLC; B. Chen, PhD, Early Development, Janssen China Research and Development; T. Ge, PhD, Biostatistics Department, Janssen Research & Development, LLC; B. Zhou, PhD, Biostatistics, Janssen Research & Development, LLC; D.G. Baker, MD, Immunology Department, Janssen Research & Development, LLC; D. Pavlova, MD, Rheumatology, M&M Centers Ltd.; C.T. Ritchlin, MD, Immunology Department, University of Rochester; Y. Tanaka, MD, PhD, Internal Medicine, University of Occupational and Environmental Health; T. Takeuchi, MD, PhD, Rheumatology, Keio University Hospital; J.S. Smolen, MD, Rheumatology, Medical University of Vienna and Hietzing Hospital.
authors.forename: Bin
authors.initials: B
authors.lastname: Chen
authors.affiliation: From the Immunology department, Janssen Research & Development, LLC, San Diego, California; the Medical Affairs department, Janssen Research & Development, LLC, Horsham, Pennsylvania; the Biostatistics department and the Immunology department, Janssen Research & Development, LLC, Spring House, Pennsylvania, USA; Early Development, Janssen China Research and Development, Shanghai, China; the Biostatistics department, Janssen Research & Development, LLC, Belmont, Massachusetts, USA; Rheumatology Department, M&M Centers LTD., Adazi, Latvia; Immunology Department, University of Rochester, Rochester, New York, USA; Internal Medicine, University of Occupational and Environmental Health, Kitakyushu; Rheumatology, Keio University Hospital, Tokyo, Japan; Rheumatology, Medical University of Vienna and Hietzing Hospital, Vienna, Austria.R.L. Thurmond, PhD, Immunology Department, Janssen Research & Development, LLC; A. Greenspan, MD, Medical Affairs Department, Janssen Research & Development, LLC; W. Radziszewski, MD, PhD, Immunology Department, Janssen Research & Development, LLC; X.L. Xu, PhD, Immunology Department, Janssen Research & Development, LLC; Y. Miao, MS, Biostatistics Department, Janssen Research & Development, LLC; B. Chen, PhD, Early Development, Janssen China Research and Development; T. Ge, PhD, Biostatistics Department, Janssen Research & Development, LLC; B. Zhou, PhD, Biostatistics, Janssen Research & Development, LLC; D.G. Baker, MD, Immunology Department, Janssen Research & Development, LLC; D. Pavlova, MD, Rheumatology, M&M Centers Ltd.; C.T. Ritchlin, MD, Immunology Department, University of Rochester; Y. Tanaka, MD, PhD, Internal Medicine, University of Occupational and Environmental Health; T. Takeuchi, MD, PhD, Rheumatology, Keio University Hospital; J.S. Smolen, MD, Rheumatology, Medical University of Vienna and Hietzing Hospital.
authors.forename: TingTing
authors.initials: T
authors.lastname: Ge
authors.affiliation: From the Immunology department, Janssen Research & Development, LLC, San Diego, California; the Medical Affairs department, Janssen Research & Development, LLC, Horsham, Pennsylvania; the Biostatistics department and the Immunology department, Janssen Research & Development, LLC, Spring House, Pennsylvania, USA; Early Development, Janssen China Research and Development, Shanghai, China; the Biostatistics department, Janssen Research & Development, LLC, Belmont, Massachusetts, USA; Rheumatology Department, M&M Centers LTD., Adazi, Latvia; Immunology Department, University of Rochester, Rochester, New York, USA; Internal Medicine, University of Occupational and Environmental Health, Kitakyushu; Rheumatology, Keio University Hospital, Tokyo, Japan; Rheumatology, Medical University of Vienna and Hietzing Hospital, Vienna, Austria.R.L. Thurmond, PhD, Immunology Department, Janssen Research & Development, LLC; A. Greenspan, MD, Medical Affairs Department, Janssen Research & Development, LLC; W. Radziszewski, MD, PhD, Immunology Department, Janssen Research & Development, LLC; X.L. Xu, PhD, Immunology Department, Janssen Research & Development, LLC; Y. Miao, MS, Biostatistics Department, Janssen Research & Development, LLC; B. Chen, PhD, Early Development, Janssen China Research and Development; T. Ge, PhD, Biostatistics Department, Janssen Research & Development, LLC; B. Zhou, PhD, Biostatistics, Janssen Research & Development, LLC; D.G. Baker, MD, Immunology Department, Janssen Research & Development, LLC; D. Pavlova, MD, Rheumatology, M&M Centers Ltd.; C.T. Ritchlin, MD, Immunology Department, University of Rochester; Y. Tanaka, MD, PhD, Internal Medicine, University of Occupational and Environmental Health; T. Takeuchi, MD, PhD, Rheumatology, Keio University Hospital; J.S. Smolen, MD, Rheumatology, Medical University of Vienna and Hietzing Hospital.
authors.forename: Bei
authors.initials: B
authors.lastname: Zhou
authors.affiliation: From the Immunology department, Janssen Research & Development, LLC, San Diego, California; the Medical Affairs department, Janssen Research & Development, LLC, Horsham, Pennsylvania; the Biostatistics department and the Immunology department, Janssen Research & Development, LLC, Spring House, Pennsylvania, USA; Early Development, Janssen China Research and Development, Shanghai, China; the Biostatistics department, Janssen Research & Development, LLC, Belmont, Massachusetts, USA; Rheumatology Department, M&M Centers LTD., Adazi, Latvia; Immunology Department, University of Rochester, Rochester, New York, USA; Internal Medicine, University of Occupational and Environmental Health, Kitakyushu; Rheumatology, Keio University Hospital, Tokyo, Japan; Rheumatology, Medical University of Vienna and Hietzing Hospital, Vienna, Austria.R.L. Thurmond, PhD, Immunology Department, Janssen Research & Development, LLC; A. Greenspan, MD, Medical Affairs Department, Janssen Research & Development, LLC; W. Radziszewski, MD, PhD, Immunology Department, Janssen Research & Development, LLC; X.L. Xu, PhD, Immunology Department, Janssen Research & Development, LLC; Y. Miao, MS, Biostatistics Department, Janssen Research & Development, LLC; B. Chen, PhD, Early Development, Janssen China Research and Development; T. Ge, PhD, Biostatistics Department, Janssen Research & Development, LLC; B. Zhou, PhD, Biostatistics, Janssen Research & Development, LLC; D.G. Baker, MD, Immunology Department, Janssen Research & Development, LLC; D. Pavlova, MD, Rheumatology, M&M Centers Ltd.; C.T. Ritchlin, MD, Immunology Department, University of Rochester; Y. Tanaka, MD, PhD, Internal Medicine, University of Occupational and Environmental Health; T. Takeuchi, MD, PhD, Rheumatology, Keio University Hospital; J.S. Smolen, MD, Rheumatology, Medical University of Vienna and Hietzing Hospital.
authors.forename: Daniel G
authors.initials: DG
authors.lastname: Baker
authors.affiliation: From the Immunology department, Janssen Research & Development, LLC, San Diego, California; the Medical Affairs department, Janssen Research & Development, LLC, Horsham, Pennsylvania; the Biostatistics department and the Immunology department, Janssen Research & Development, LLC, Spring House, Pennsylvania, USA; Early Development, Janssen China Research and Development, Shanghai, China; the Biostatistics department, Janssen Research & Development, LLC, Belmont, Massachusetts, USA; Rheumatology Department, M&M Centers LTD., Adazi, Latvia; Immunology Department, University of Rochester, Rochester, New York, USA; Internal Medicine, University of Occupational and Environmental Health, Kitakyushu; Rheumatology, Keio University Hospital, Tokyo, Japan; Rheumatology, Medical University of Vienna and Hietzing Hospital, Vienna, Austria.R.L. Thurmond, PhD, Immunology Department, Janssen Research & Development, LLC; A. Greenspan, MD, Medical Affairs Department, Janssen Research & Development, LLC; W. Radziszewski, MD, PhD, Immunology Department, Janssen Research & Development, LLC; X.L. Xu, PhD, Immunology Department, Janssen Research & Development, LLC; Y. Miao, MS, Biostatistics Department, Janssen Research & Development, LLC; B. Chen, PhD, Early Development, Janssen China Research and Development; T. Ge, PhD, Biostatistics Department, Janssen Research & Development, LLC; B. Zhou, PhD, Biostatistics, Janssen Research & Development, LLC; D.G. Baker, MD, Immunology Department, Janssen Research & Development, LLC; D. Pavlova, MD, Rheumatology, M&M Centers Ltd.; C.T. Ritchlin, MD, Immunology Department, University of Rochester; Y. Tanaka, MD, PhD, Internal Medicine, University of Occupational and Environmental Health; T. Takeuchi, MD, PhD, Rheumatology, Keio University Hospital; J.S. Smolen, MD, Rheumatology, Medical University of Vienna and Hietzing Hospital.
authors.forename: Dace
authors.initials: D
authors.lastname: Pavlova
authors.affiliation: From the Immunology department, Janssen Research & Development, LLC, San Diego, California; the Medical Affairs department, Janssen Research & Development, LLC, Horsham, Pennsylvania; the Biostatistics department and the Immunology department, Janssen Research & Development, LLC, Spring House, Pennsylvania, USA; Early Development, Janssen China Research and Development, Shanghai, China; the Biostatistics department, Janssen Research & Development, LLC, Belmont, Massachusetts, USA; Rheumatology Department, M&M Centers LTD., Adazi, Latvia; Immunology Department, University of Rochester, Rochester, New York, USA; Internal Medicine, University of Occupational and Environmental Health, Kitakyushu; Rheumatology, Keio University Hospital, Tokyo, Japan; Rheumatology, Medical University of Vienna and Hietzing Hospital, Vienna, Austria.R.L. Thurmond, PhD, Immunology Department, Janssen Research & Development, LLC; A. Greenspan, MD, Medical Affairs Department, Janssen Research & Development, LLC; W. Radziszewski, MD, PhD, Immunology Department, Janssen Research & Development, LLC; X.L. Xu, PhD, Immunology Department, Janssen Research & Development, LLC; Y. Miao, MS, Biostatistics Department, Janssen Research & Development, LLC; B. Chen, PhD, Early Development, Janssen China Research and Development; T. Ge, PhD, Biostatistics Department, Janssen Research & Development, LLC; B. Zhou, PhD, Biostatistics, Janssen Research & Development, LLC; D.G. Baker, MD, Immunology Department, Janssen Research & Development, LLC; D. Pavlova, MD, Rheumatology, M&M Centers Ltd.; C.T. Ritchlin, MD, Immunology Department, University of Rochester; Y. Tanaka, MD, PhD, Internal Medicine, University of Occupational and Environmental Health; T. Takeuchi, MD, PhD, Rheumatology, Keio University Hospital; J.S. Smolen, MD, Rheumatology, Medical University of Vienna and Hietzing Hospital.
authors.forename: Christopher T
authors.initials: CT
authors.lastname: Ritchlin
authors.affiliation: From the Immunology department, Janssen Research & Development, LLC, San Diego, California; the Medical Affairs department, Janssen Research & Development, LLC, Horsham, Pennsylvania; the Biostatistics department and the Immunology department, Janssen Research & Development, LLC, Spring House, Pennsylvania, USA; Early Development, Janssen China Research and Development, Shanghai, China; the Biostatistics department, Janssen Research & Development, LLC, Belmont, Massachusetts, USA; Rheumatology Department, M&M Centers LTD., Adazi, Latvia; Immunology Department, University of Rochester, Rochester, New York, USA; Internal Medicine, University of Occupational and Environmental Health, Kitakyushu; Rheumatology, Keio University Hospital, Tokyo, Japan; Rheumatology, Medical University of Vienna and Hietzing Hospital, Vienna, Austria.R.L. Thurmond, PhD, Immunology Department, Janssen Research & Development, LLC; A. Greenspan, MD, Medical Affairs Department, Janssen Research & Development, LLC; W. Radziszewski, MD, PhD, Immunology Department, Janssen Research & Development, LLC; X.L. Xu, PhD, Immunology Department, Janssen Research & Development, LLC; Y. Miao, MS, Biostatistics Department, Janssen Research & Development, LLC; B. Chen, PhD, Early Development, Janssen China Research and Development; T. Ge, PhD, Biostatistics Department, Janssen Research & Development, LLC; B. Zhou, PhD, Biostatistics, Janssen Research & Development, LLC; D.G. Baker, MD, Immunology Department, Janssen Research & Development, LLC; D. Pavlova, MD, Rheumatology, M&M Centers Ltd.; C.T. Ritchlin, MD, Immunology Department, University of Rochester; Y. Tanaka, MD, PhD, Internal Medicine, University of Occupational and Environmental Health; T. Takeuchi, MD, PhD, Rheumatology, Keio University Hospital; J.S. Smolen, MD, Rheumatology, Medical University of Vienna and Hietzing Hospital.
authors.forename: Yoshiya
authors.initials: Y
authors.lastname: Tanaka
authors.affiliation: From the Immunology department, Janssen Research & Development, LLC, San Diego, California; the Medical Affairs department, Janssen Research & Development, LLC, Horsham, Pennsylvania; the Biostatistics department and the Immunology department, Janssen Research & Development, LLC, Spring House, Pennsylvania, USA; Early Development, Janssen China Research and Development, Shanghai, China; the Biostatistics department, Janssen Research & Development, LLC, Belmont, Massachusetts, USA; Rheumatology Department, M&M Centers LTD., Adazi, Latvia; Immunology Department, University of Rochester, Rochester, New York, USA; Internal Medicine, University of Occupational and Environmental Health, Kitakyushu; Rheumatology, Keio University Hospital, Tokyo, Japan; Rheumatology, Medical University of Vienna and Hietzing Hospital, Vienna, Austria.R.L. Thurmond, PhD, Immunology Department, Janssen Research & Development, LLC; A. Greenspan, MD, Medical Affairs Department, Janssen Research & Development, LLC; W. Radziszewski, MD, PhD, Immunology Department, Janssen Research & Development, LLC; X.L. Xu, PhD, Immunology Department, Janssen Research & Development, LLC; Y. Miao, MS, Biostatistics Department, Janssen Research & Development, LLC; B. Chen, PhD, Early Development, Janssen China Research and Development; T. Ge, PhD, Biostatistics Department, Janssen Research & Development, LLC; B. Zhou, PhD, Biostatistics, Janssen Research & Development, LLC; D.G. Baker, MD, Immunology Department, Janssen Research & Development, LLC; D. Pavlova, MD, Rheumatology, M&M Centers Ltd.; C.T. Ritchlin, MD, Immunology Department, University of Rochester; Y. Tanaka, MD, PhD, Internal Medicine, University of Occupational and Environmental Health; T. Takeuchi, MD, PhD, Rheumatology, Keio University Hospital; J.S. Smolen, MD, Rheumatology, Medical University of Vienna and Hietzing Hospital.
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Takeuchi
authors.affiliation: From the Immunology department, Janssen Research & Development, LLC, San Diego, California; the Medical Affairs department, Janssen Research & Development, LLC, Horsham, Pennsylvania; the Biostatistics department and the Immunology department, Janssen Research & Development, LLC, Spring House, Pennsylvania, USA; Early Development, Janssen China Research and Development, Shanghai, China; the Biostatistics department, Janssen Research & Development, LLC, Belmont, Massachusetts, USA; Rheumatology Department, M&M Centers LTD., Adazi, Latvia; Immunology Department, University of Rochester, Rochester, New York, USA; Internal Medicine, University of Occupational and Environmental Health, Kitakyushu; Rheumatology, Keio University Hospital, Tokyo, Japan; Rheumatology, Medical University of Vienna and Hietzing Hospital, Vienna, Austria.R.L. Thurmond, PhD, Immunology Department, Janssen Research & Development, LLC; A. Greenspan, MD, Medical Affairs Department, Janssen Research & Development, LLC; W. Radziszewski, MD, PhD, Immunology Department, Janssen Research & Development, LLC; X.L. Xu, PhD, Immunology Department, Janssen Research & Development, LLC; Y. Miao, MS, Biostatistics Department, Janssen Research & Development, LLC; B. Chen, PhD, Early Development, Janssen China Research and Development; T. Ge, PhD, Biostatistics Department, Janssen Research & Development, LLC; B. Zhou, PhD, Biostatistics, Janssen Research & Development, LLC; D.G. Baker, MD, Immunology Department, Janssen Research & Development, LLC; D. Pavlova, MD, Rheumatology, M&M Centers Ltd.; C.T. Ritchlin, MD, Immunology Department, University of Rochester; Y. Tanaka, MD, PhD, Internal Medicine, University of Occupational and Environmental Health; T. Takeuchi, MD, PhD, Rheumatology, Keio University Hospital; J.S. Smolen, MD, Rheumatology, Medical University of Vienna and Hietzing Hospital.
authors.forename: Josef S
authors.initials: JS
authors.lastname: Smolen
mesh_terms: D018501:Antirheumatic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D006633:Histamine Antagonists / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D051359:Lymphohistiocytosis, Hemophagocytic / Q000139:chemically induced; D008727:Methotrexate / Q000627:therapeutic use; D000074040:Receptors, Histamine H4 / Q000037:antagonists & inhibitors*; D017211:Treatment Failure; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents; D006633:Histamine Antagonists; D000074040:Receptors, Histamine H4; D008727:Methotrexate
keywords: CLINICAL TRIAL; HISTAMINE H4 RECEPTOR ANTAGONIST; METHOTREXATE; RHEUMATOID ARTHRITIS