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International multicenter randomized, placebo-controlled phase III clinical trial of ß-D-mannuronic acid in rheumatoid arthritis patients.
Rezaieyazdi, Zahra; Farooqi, Abid; Soleymani-Salehabadi, Hossein; Ahmadzadeh, Arman; Aslani, Mona; Omidian, Saiedeh; Sadoughi, Arezoo; Vahidi, Zohreh; Khodashahi, Mandana; Zamurrad, Shazia; Mortazavi-Jahromi, Seyed Shahabeddin; Fallahzadeh, Hossein; Hosseini, Mostafa; Aghazadeh, Zahra; Ekhtiari, Parvin; Matsuo, Hidenori; Rehm, Bernd H A; Cuzzocrea, Salvatore; D'Aniello, Antimo; Mirshafiey, Abbas.
Afiliación
  • Rezaieyazdi Z; Rheumatic Diseases Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.
  • Farooqi A; Department of Rheumatology, Pakistan Institute of Medical Sciences, Islamabad, Pakistan.
  • Soleymani-Salehabadi H; Department of Rheumatology, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
  • Ahmadzadeh A; Department of Rheumatology, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
  • Aslani M; Department of Immunology, School of Public Health, Tehran University of Medical Sciences, Box: 14155-6446, Tehran, Iran.
  • Omidian S; Department of Immunology, School of Public Health, Tehran University of Medical Sciences, Box: 14155-6446, Tehran, Iran.
  • Sadoughi A; Department of Immunology, School of Public Health, Tehran University of Medical Sciences, Box: 14155-6446, Tehran, Iran.
  • Vahidi Z; Inflammation and Inflammatory Diseases Research Center, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.
  • Khodashahi M; Rheumatic Diseases Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.
  • Zamurrad S; Department of Rheumatology, Pakistan Institute of Medical Sciences, Islamabad, Pakistan.
  • Mortazavi-Jahromi SS; Department of Immunology, School of Public Health, Tehran University of Medical Sciences, Box: 14155-6446, Tehran, Iran.
  • Fallahzadeh H; Research Center of Prevention and Epidemiology of Non-Communicable Disease, Departments of Biostatistics and Epidemiology, Faculty of Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
  • Hosseini M; Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.
  • Aghazadeh Z; Department of Immunology, School of Public Health, Tehran University of Medical Sciences, Box: 14155-6446, Tehran, Iran.
  • Ekhtiari P; Department of Immunology, School of Public Health, Tehran University of Medical Sciences, Box: 14155-6446, Tehran, Iran.
  • Matsuo H; Nagasaki National Hospital, Sakuragi-cho 6-41, Nagasaki, Japan.
  • Rehm BHA; Centre for Cell Factories and Biopolymers, Griffith Institute for Drug Discovery, Griffith University, Nathan, QLD, Australia.
  • Cuzzocrea S; Department of Chemical, Biological, Pharmaceutical and Environmental Sciences, University of Messina, Messina, Italy.
  • D'Aniello A; Laboratory of Neurobiology, Zoological Station of Naples "Anton Dohrn", Villa Comunale, Naples, Italy.
  • Mirshafiey A; Department of Immunology, School of Public Health, Tehran University of Medical Sciences, Box: 14155-6446, Tehran, Iran. mirshafiey@tums.ac.ir.
Inflammopharmacology ; 27(5): 911-921, 2019 Oct.
Article en En | MEDLINE | ID: mdl-30604197
BACKGROUND: The oral administration of drug ß-D-mannuronic acid (M2000) showed a potent therapeutic effect in phase I/II study in rheumatoid arthritis (RA) patients. Here, our aim is to assess the efficacy and safety of this new drug in RA patients under a multinational, randomized placebo-controlled phase III clinical trial. METHOD: Patients (n = 288) with active disease at baseline and inadequate response to conventional drugs were randomly allocated to three groups; (1) receiving mannuronic acid at a dose of two capsules (500 mg) per day orally for 12 weeks, (2) placebo-controlled, and (3) conventional. The primary endpoints were the America College of Rheumatology 20 response (ACR20), 28-joint disease activity score (DAS28) and Modified Health Assessment Questionnaire-Disability Index (M-HAQ-DI). In addition, the participants were followed-up for safety assessment. RESULTS: In this phase III trial, after 12 weeks of treatment, there was a significant reduction in ACR20 between mannuronic-treated patients compared to placebo and conventional groups. Moreover, there was a similar significant improvement for DAS28 following mannuronic therapy. The statistical analysis showed a significant reduction in the swollen and tender joint count in mannuronic-treated patients compared with the placebo group. On the other side, mannuronic acid showed no-to-very low adverse events in comparison to placebo. CONCLUSION: The results of this multinational, phase III clinical trial provided a potent evidence base for the use of ß-D-mannuronic acid as a new highly safe and efficient drug in the treatment of RA.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Artritis Reumatoide / Antirreumáticos / Ácidos Hexurónicos Tipo de estudio: Clinical_trials Límite: Female / Humans / Male / Middle aged Idioma: En Revista: Inflammopharmacology Asunto de la revista: FARMACOLOGIA / TERAPIA POR MEDICAMENTOS Año: 2019 Tipo del documento: Article País de afiliación: Irán Pais de publicación: Suiza
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Artritis Reumatoide / Antirreumáticos / Ácidos Hexurónicos Tipo de estudio: Clinical_trials Límite: Female / Humans / Male / Middle aged Idioma: En Revista: Inflammopharmacology Asunto de la revista: FARMACOLOGIA / TERAPIA POR MEDICAMENTOS Año: 2019 Tipo del documento: Article País de afiliación: Irán Pais de publicación: Suiza