A randomized clinical trial for the assessment of the efficacy and safety of guluronic acid (G2013) in patients with rheumatoid arthritis

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).

Keywords:

• Guluronic acid
• G2013
• rheumatoid arthritis
• NSAIDs
• DMARDs

Acknowledgements

We would appreciate the nurses and staff of Rheumatology Research Center, Shariati Hospital, Tehran University of Medical Sciences (TUMS).

Disclosure statement

The authors declare no conflict of interest.

Table 6. Biochemical parameters in RA patients treated with guluronic acid, 500 mg two times per day.