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Intranasal administration of recombinant Human Cartilage glycoprotein-39 as a treatment for rheumatoid arthritis: A Phase II, multicenter, double-blind, randomized, placebo-controlled, parallel group dose-finding trial
  1. Robert BM Landewé (r.landewe{at}mumc.nl)
  1. University of Maastricht, Netherlands
    1. Jos G A Houbiers (j.houbiers{at}planet.nl)
    1. Schering-Plough, Netherlands
      1. Filip E Van den Bosch (filip.vandenbosch{at}ugent.be)
      1. University Hospital Gent, Belgium
        1. Joanna in 't Hout (joanna.inthout{at}spcorp.com)
        1. Schering-Plough, Netherlands
          1. Patrick CPM Verschueren (patrick.verschueren{at}uz.kuleuven.ac.be)
          1. University Hospitals Leuven, Belgium
            1. Jan H Meijerink (meijerink{at}telebyte.nl)
            1. Schering-Plough, Netherlands
              1. Frank H J van den Hoogen (f.vandenhoogen{at}maartenskliniek.nl)
              1. Sint Maartens Clinic Nijmegen, Netherlands
                1. Bedrich A Masek (bmasek{at}xs4all.nl)
                1. VieCuri Medical Center Noord-Limburg, Netherlands
                  1. George AW Bruyn (gaw.bruyn{at}znb.nl)
                  1. Medical Center Leeuwarden South, Netherlands
                    1. Jacques MGW Wouters (j.wouters{at}sfg.nl)
                    1. St Franciscus Hospital, Netherlands
                      1. Alexandre E Voskuyl (ae.voskuyl{at}vumc.nl)
                      1. VU University Medical Center, Netherlands
                        1. Jacob M van Laar (j.m.van-laar{at}newcastle.ac.uk)
                        1. Leiden University Medical Centre, Netherlands
                          1. Johannes J W Bijlsma (j.w.j.bijlsma{at}umcutrecht.nl)
                          1. University Medical Center Utrecht, Netherlands
                            1. Desiree MFM van der Heijde (d.vanderheijde{at}kpnplanet.nl)
                            1. University Hospital Maastricht, Netherlands
                              1. Ferdinand C Breedveld (f.c.breedveld{at}lumc.nl)
                              1. Leiden University Medical Centre, Netherlands
                                1. Leo B A van de Putte (l.vandeputte{at}reuma.umcn.nl)
                                1. University Medical Center Nijmegen, Netherlands
                                  1. André M M Miltenburg (a.miltenburg{at}spcorp.com)
                                  1. Schering-Plough, Netherlands
                                    1. Filip De Keyser (filip.dekeyser{at}ugent.be)
                                    1. University Hospital Gent, Belgium

                                      Abstract

                                      Objective: Autoantigen-specific immunotherapy by means of mucosal tolerance induction via the intranasal route is an attractive therapeutic option for the treatment of autoimmune diseases, including rheumatoid arthritis (RA). Human Cartilage glycoprotein-39 (HC gp-39) has been identified as a potential key autoantigen in RA. Based on animal studies, intranasal administration of the autoantigen is hypothesized to induce immunological tolerance in RA patients and to ameliorate disease activity. In a Phase I/IIA clinical trial in RA patients, intranasal application of HC gp-39 was safe and well tolerated. The current paper describes the first large clinical study investigating the efficacy of intranasally administered fully human, recombinant HC gp-39 (Org 39141).

                                      Methods: In a 13-wk multicenter, double-blind, randomized, placebo-controlled, parallel group, dose-finding, Proof-of-Concept trial, patients with RA (DMARD naïve or following wash-out of DMARD therapy) were randomized to receive either intranasal applications of placebo or HC gp-39 in doses of 30, 150, 300 or 600 micrograms, once per week. The primary efficacy variable was the DAS28.

                                      Results: During the treatment period the DAS28 decreased similarly for all treatment groups - including placebo - indicating lack of efficacy of intranasal HC gp-39 therapy in the current setting. Safety variables were similar for all study groups.

                                      Conclusion: It was concluded that, with the use of the chosen treatment protocol (dose levels and frequency of dosing), intranasal treatment with Org 39141 was safe but did not result in clinical improvement different from that seen in placebo-treated patients.

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