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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 [Extended Report]
Annals of Rheumatic Diseases, 10/07/09

Landewé RBM et al. – 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.

Methods

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) randomized to receive either intranasal applications of placebo or HC gp-39 in doses of 30, 150, 300 or 600 micrograms, once per week
Primary efficacy variable was DAS28

Results

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

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