EXTENDED REPORT MOR103, a human monoclonal antibody to granulocyte–macrophage colony-stimulating factor, in the treatment of patients with moderate rheumatoid arthritis: results of a phase Ib/IIa randomised, double-blind, placebo-controlled, dose-escalation trial

نویسندگان

  • Frank Behrens
  • Paul P Tak
  • Mikkel Østergaard
  • Rumen Stoilov
  • Piotr Wiland
  • Thomas W Huizinga
  • Vadym Y Berenfus
  • Stoyanka Vladeva
  • Juergen Rech
  • Andrea Rubbert-Roth
  • Mariusz Korkosz
  • Dmitriy Rekalov
  • Igor A Zupanets
  • Bo J Ejbjerg
  • Jens Geiseler
  • Julia Fresenius
  • Roman P Korolkiewicz
  • Arndt J Schottelius
  • Harald Burkhardt
  • Tore K Kvien
چکیده

MOR103, a human monoclonal antibody to granulocyte–macrophage colony-stimulating factor, in the treatment of patients with moderate rheumatoid arthritis: results of a phase Ib/IIa randomised, double-blind, placebo-controlled, dose-escalation trial Frank Behrens, Paul P Tak, Mikkel Østergaard, Rumen Stoilov, Piotr Wiland, Thomas W Huizinga, Vadym Y Berenfus, Stoyanka Vladeva, Juergen Rech, Andrea Rubbert-Roth, Mariusz Korkosz, Dmitriy Rekalov, Igor A Zupanets, Bo J Ejbjerg, Jens Geiseler, Julia Fresenius, Roman P Korolkiewicz, Arndt J Schottelius, Harald Burkhardt

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MOR103, a human monoclonal antibody to granulocyte–macrophage colony-stimulating factor, in the treatment of patients with moderate rheumatoid arthritis: results of a phase Ib/IIa randomised, double-blind, placebo-controlled, dose-escalation trial

OBJECTIVES To determine the safety, tolerability and signs of efficacy of MOR103, a human monoclonal antibody to granulocyte-macrophage colony-stimulating factor (GM-CSF), in patients with rheumatoid arthritis (RA). METHODS Patients with active, moderate RA were enrolled in a randomised, multicentre, double-blind, placebo-controlled, dose-escalation trial of intravenous MOR103 (0.3, 1.0 or 1....

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OBJECTIVE To evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic profiles of mavrilimumab, a human monoclonal antibody targeting the granulocyte-macrophage colony-stimulating factor receptor-α, in subjects with rheumatoid arthritis (RA). METHODS A randomised, double-blind, placebo-controlled, dose-escalating phase I study in subjects with RA who received stable methotrexate...

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BACKGROUND Namilumab (AMG203) is an immunoglobulin G1 monoclonal antibody that binds with high affinity to the GM-CSF ligand. This was a phase 1b, randomized, double-blind study (PRIORA) to assess namilumab in active, mild-to-moderate rheumatoid arthritis (RA). The primary outcome was the safety and tolerability of repeated subcutaneous injections of namilumab in patients with mild-to-moderate ...

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A randomised phase IIb study of mavrilimumab, a novel GM-CSF receptor alpha monoclonal antibody, in the treatment of rheumatoid arthritis.

OBJECTIVES Despite the therapeutic value of current rheumatoid arthritis (RA) treatments, agents with alternative modes of action are required. Mavrilimumab, a fully human monoclonal antibody targeting the granulocyte-macrophage colony-stimulating factor receptor-α, was evaluated in patients with moderate-to-severe RA. METHODS In a phase IIb study (NCT01706926), patients with inadequate respo...

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تاریخ انتشار 2015