Intranasal administration of recombinant human cartilage glycoprotein-39 as a treatment for rheumatoid arthritis: a phase II, multicentre, double-blind, randomised, placebo-controlled, parallel-group, dose-finding trial
| العنوان: | Intranasal administration of recombinant human cartilage glycoprotein-39 as a treatment for rheumatoid arthritis: a phase II, multicentre, double-blind, randomised, placebo-controlled, parallel-group, dose-finding trial |
|---|---|
| المؤلفون: | Ferdinand C. Breedveld, Joanna in 't Hout, Jacob M van Laar, J. M. G. W. Wouters, Patrick Verschueren, Filip De Keyser, Robert B M Landewé, Bedrich A Masek, Désirée van der Heijde, Frank H J van den Hoogen, George A W Bruyn, Leo B A van de Putte, Filip Van den Bosch, Jan Meijerink, Alexandre E. Voskuyl, Johannes J W Bijlsma, Jos G A Houbiers, André M. M. Miltenburg |
| المساهمون: | Other departments, Interne Geneeskunde, RS: CAPHRI School for Public Health and Primary Care, Rheumatology, CCA - Innovative therapy |
| المصدر: | Annals of the Rheumatic Diseases, 69(9), 1655-1659 Annals of the rheumatic diseases, 69(9), 1655-1659. BMJ Publishing Group Annals of the Rheumatic Diseases, 69(9), 1655-1659. BMJ Publishing Group Landewe, R B M, Houbiers, J G A, Bosch, F, in't Hout, J, Verschueren, P C P M, Meijerink, J H, van den Hoogen, F H J, Masek, B A, Bruyn, G A W, Wouters, J M G W, Voskuyl, A E, van Laar, JM, Bijlsma, J J W, van der Heijde, D M F M, Breedveld, F C, van de Putte, L B A, Miltenburg, A M M & de Keyser, F 2010, ' Intranasal administration of recombinant human cartilage glycoprotein-39 as a treatment for rheumatoid arthritis: a phase II, multicentre, double-blind, randomised, placebo-controlled, parallel-group, dose-finding trial ', Annals of the Rheumatic Diseases, vol. 69, no. 9, pp. 1655-1659 . https://doi.org/10.1136/ard.2009.117234 |
| سنة النشر: | 2010 |
| مصطلحات موضوعية: | Male, medicine.medical_specialty, Immunology, Arthritis, Placebo, Gastroenterology, Severity of Illness Index, General Biochemistry, Genetics and Molecular Biology, law.invention, Arthritis, Rheumatoid, Rheumatology, Randomized controlled trial, Adipokines, Double-Blind Method, law, Internal medicine, Lectins, medicine, Immunology and Allergy, Humans, Chitinase-3-Like Protein 1, Administration, Intranasal, Glycoproteins, business.industry, Middle Aged, medicine.disease, Recombinant Proteins, college-of-rheumatology oral tolerance gp-39 joint, Clinical trial, Treatment Outcome, Rheumatoid arthritis, Antirheumatic Agents, Patient Compliance, Nasal administration, Mucosal tolerance induction, Female, business, Immunosuppressive Agents |
| الوصف: | Background Autoantigen-specific immunotherapy by 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 hypothesised to induce immunological tolerance in patients with RA and to ameliorate disease activity. In a phase I/IIA clinical trial in patients with RA, intranasal application of HC gp-39 was safe and well tolerated. Objective To investigate the efficacy of intranasally administered fully human, recombinant HC gp-39 (Org 39141) by a large clinical study. Methods In a 13-week multicentre, double-blind, randomised, placebo-controlled, parallel-group, dose-finding, proof-of-concept trial, patients with RA (disease-modifying antirheumatic drug (DMARD) naive or after washout of DMARD treatment) were randomised to receive either intranasal applications of placebo or HC gp-39 in doses of 30, 150, 300 or 600 µg, once a week. The primary efficacy variable was the 28 joint count Disease Activity Score (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 treatment in the current setting. Safety variables were similar for all study groups. Conclusion It was concluded that with the treatment protocol used (dose levels and frequency of dosing), intranasal treatment with Org 39141 was safe but did not result in more clinical improvement than in placebo-treated patients. |
| اللغة: | English |
| تدمد: | 0003-4967 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::df30bb0f8cb756c61711f4d5efbca7b4 http://hdl.handle.net/1887/110392 |
| حقوق: | RESTRICTED |
| رقم الأكسشن: | edsair.doi.dedup.....df30bb0f8cb756c61711f4d5efbca7b4 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 00034967 |
|---|