Tehran University of Medical Sciences

Science Communicator Platform

Stay connected! Follow us on X network (Twitter):
Share this content! On (X network) By
A Randomized Clinical Trial for the Assessment of the Efficacy and Safety of Guluronic Acid (G2013) in Patients With Rheumatoid Arthritis Publisher Pubmed



Khadem Azarian S1 ; Akhlaghi M2 ; Mahmoudi M2 ; Mostafaei S2, 3 ; Jamshidi AR2 ; Nazeri S1 ; Mirshafiey A1
Authors
Show Affiliations
Authors Affiliations
  1. 1. Department of Immunology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran
  2. 2. Rheumatology Research Center, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran
  3. 3. Department of Community Medicine, Faculty of Medicine, Kermanshah University of Medical Sciences, Kermanshah, Iran

Source: Immunopharmacology and Immunotoxicology Published:2019


Abstract

Objective: To evaluate the safety, efficacy and tolerability of guluronic acid (G2013) in order to treat the rheumatoid arthritis patients who had inadequate response to conventional drugs. Methods: A randomized, 12-week clinical trial with two treatment arms: guluronic acid (G2013) and conventional treatment was performed. The diagnosed RA patients according to the ACR/European League against Rheumatism 2010 classification criteria, with an active disease at baseline that had inadequate response to conventional therapy were considered for the study. G2013 was administered orally twice a day with capsules of 500 mg during a period of 12 weeks and the patients were followed up for the safety and efficacy. Results: Our data showed that, the mean changes in the G2013 and control groups were −7.54 and −2.5 for tender joint count; −7.59 and −3.59 for swollen joint count; −30 and −0.9 for physician global assessment; −23.18 and −1.81 for patient global assessment; −14.45 and −1.45 for erythrocyte sedimentation rate, respectively. Improvements seen with G2013 were significantly greater than those with conventional drugs. In total, in 15.3% of G2013-treated patients and 69.2% of conventional-treated patients adverse events (AEs) occurred in this study. Conclusion: These data from routine rheumatology clinical practice highlight the effectivenessof G2013 in combination with conventional therapy with more desirable safety profile compared to the conventional-treated patients. Therefore, G2013 therapy could be an appropriate choice in order to manage the RA disease. (Clinical trial identifier: IRCT2016092813739N5). © 2019, © 2019 Informa UK Limited, trading as Taylor & Francis Group.
Related Docs
View other Related Docs
1. The Application of G2013 (Α-L-Guluronic Acid) As an Anti-Inflammatory Drug Candidate in Treatment of Disease, Journal of Isfahan Medical School (2021)
2. Assessment of Immunological Profile in Ankylosing Spondylitis Patients Following a Clinical Trial With Guluronic Acid (G2013), As a New Nsaid With Immunomodulatory Properties, Immunologic Research (2019)
3. The Evaluation of Safety Property and Apoptotic Efficacy of Α-L-Guluronic Acid (G2013), As a Novel Nsaid, Under in Vitro Examination on L929 and Hepatocellular Carcinoma Cell Lines, Recent Advances in Inflammation and Allergy Drug Discovery (2021)
4. A Phase I/Ii Randomized, Controlled, Clinical Trial for Assessment of the Efficacy and Safety of Β-D-Mannuronic Acid in Rheumatoid Arthritis Patients, Inflammopharmacology (2018)
5. The Open, Randomized, Positive Control Clinical Trial of Guluronic Acid (G2013) on Sars-Cov-2 Patients, Current Drug Discovery Technologies (2023)
6. Effects of Guluronic Acid, As a New Nsaid With Immunomodulatory Properties on Il-17, Rorγt, Il-4 and Gata-3 Gene Expression in Rheumatoid Arthritis Patients, Immunopharmacology and Immunotoxicology (2020)
7. The Effects of Guluronic Acid (G2013), a New Emerging Treatment, on Inflammatory Factors in Nonalcoholic Steatohepatitis Patients Under in Vitro Conditions, Immunopharmacology and Immunotoxicology (2021)
8. Evaluation of the Oral Administration of Α-L-Guluronic Acid on Cox-1 and Cox-2 Gene Expression Profile in Ankylosing Spondylitis Patients, Drug Development Research (2021)
Experts (# of related papers)
View all Related Experts
Laleh Sharifi (4)
Mostafa Hosseini (4)
Other Related Docs
9. Pivotal Cytokines and Their Transcription Factors Are the Targets of Guluronic Acid (G2013) for Inhibiting the Immunopathogenesis Process of Multiple Sclerosis, Drug Development Research (2020)
10. Evaluation of G2013 (Α-L-Guluronic Acid) Efficacy on Pc-3 Cells Through Inhibiting the Expression of Inflammatory Factors, Clinical and Experimental Pharmacology and Physiology (2022)
11. The Immunomodulatory Role of G2013 (Α-L-Guluronic Acid) on the Expression of Tlr2 and Tlr4 in Ht29 Cell Line, Current Drug Discovery Technologies (2019)
12. Anti‐Inflammatory and Anti‐Tumor Effects of Α-L-Guluronic Acid (G2013) on Cancer-Related Inflammation in a Murine Breast Cancer Model, Biomedicine and Pharmacotherapy (2018)
13. Evaluation of the Effect of Α-L-Guluronic Acid (G2013) on Cox-1, Cox-2 Activity and Gene Expression for Introducing This Drug As a Novel Nsaid With Immunomodulatory Property, Recent Patents on Inflammation and Allergy Drug Discovery (2018)
14. Anti-Diabetic and Angio-Protective Effect of Guluronic Acid (G2013) As a New Nonsteroidal Anti-Inflammatory Drug in the Experimental Model of Diabetes, Endocrine# Metabolic and Immune Disorders - Drug Targets (2020)
15. The Safety and Efficacy of Guluronic Acid (G2013) in Ankylosing Spondylitis: A Randomized Controlled Parallel Clinical Trial, Pharmacological Reports (2019)
16. Effects of Guluronic Acid (G2013) on Gene Expression of Tlr2, Tlr4, Myd88, Tnf-Α and Cd52 in Multiple Sclerosis Under in Vitro Conditions, Immunopharmacology and Immunotoxicology (2019)
17. The Potent Inhibitory Effect of Β-D-Mannuronic Acid (M2000) As a Novel Nsaid With Immunosuppressive Property on Anti-Cyclic Citrullinated Peptide Antibodies, Rheumatoid Factor and Antidsdna Antibodies in Patients With Rheumatoid Arthritis, Current Drug Discovery Technologies (2017)
18. Effects of Guluronic Acid (G2013) on Ship1, Socs1 Induction and Related Molecules in Tlr4 Signaling Pathway, International Immunopharmacology (2018)
19. Antagonistic Property of G2013 (Α-L-Guluronic Acid) on Gene Expression of Myd88, Tollip, and Nf-Κb in Hek293 Tlr2 and Hek293 Tlr4, Endocrine# Metabolic and Immune Disorders - Drug Targets (2019)
20. Evaluation of the Acute and 28-Day Sub-Acute Intravenous Toxicity of Α-L-Guluronic Acid (Alg; G2013) in Mice, Drug and Chemical Toxicology (2022)
21. International Multicenter Randomized, Placebo-Controlled Phase Iii Clinical Trial of Β-D-Mannuronic Acid in Rheumatoid Arthritis Patients, Inflammopharmacology (2019)
22. Immunomodulatory Effect of G2013 (Α-L-Guluronic Acid) on the Tlr2 and Tlr4 in Human Mononuclear Cells, Current Drug Discovery Technologies (2018)
23. Dysregulated Mirnas Network in the Critical Covid-19: An Important Clue for Uncontrolled Immunothrombosis/Thromboinflammation, International Immunopharmacology (2022)
24. Effect of Guluronic Acid (G2013), As a New Anti-Inflammatory Drug on Gene Expression of Pro-Inflammatory and Anti-Inflammatory Cytokines and Their Transcription Factors in Rheumatoid Arthritis Patients, Iranian Journal of Allergy# Asthma and Immunology (2019)
25. A Randomized, Controlled, Phase Ii Clinical Trial of Β-D-Mannuronic Acid (M2000) in Pre-Surgical Breast Cancer Patients at Early Stage (T1-T2), Clinical and Experimental Pharmacology and Physiology (2019)
26. A Phase Iii, Randomized, Two-Armed, Double-Blind, Parallel, Active Controlled, and Non-Inferiority Clinical Trial to Compare Efficacy and Safety of Biosimilar Adalimumab (Cinnora®) to the Reference Product (Humira®) in Patients With Active Rheumatoid Arthritis, Arthritis Research and Therapy (2017)
27. Strategies Toward Rheumatoid Arthritis Therapy; the Old and the New, Journal of Cellular Physiology (2019)
28. Preclinical and Pharmacotoxicology Evaluation of Α-L-Guluronic Acid (G2013) As a Non-Steroidal Anti-Inflammatory Drug With Immunomodulatory Property, Immunopharmacology and Immunotoxicology (2017)
29. The Effects of G2013 (Α-L-Guluronic Acid) in a Pentylenetetrazole-Induced Kindling Animal Model of Epilepsy, Innovations in Clinical Neuroscience (2020)
30. Immunomodulation of Tlr2 and Tlr4 by G2013 (Α-L-Guluronic Acid) in Cvid Patients, International Journal of Pediatrics (2017)
31. An in Vitro Evaluation of Anti-Aging Effect of Guluronic Acid (G2013) Based on Enzymatic Oxidative Stress Gene Expression Using Healthy Individuals Pbmcs, Biomedicine and Pharmacotherapy (2017)