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02.01.2019 | Original Article

International multicenter randomized, placebo-controlled phase III clinical trial of β-d-mannuronic acid in rheumatoid arthritis patients

verfasst von: Zahra Rezaieyazdi, Abid Farooqi, Hossein Soleymani-Salehabadi, Arman Ahmadzadeh, Mona Aslani, Saiedeh Omidian, Arezoo Sadoughi, Zohreh Vahidi, Mandana Khodashahi, Shazia Zamurrad, Seyed Shahabeddin Mortazavi-Jahromi, Hossein Fallahzadeh, Mostafa Hosseini, Zahra Aghazadeh, Parvin Ekhtiari, Hidenori Matsuo, Bernd H. A. Rehm, Salvatore Cuzzocrea, Antimo D’Aniello, Abbas Mirshafiey

Erschienen in: Inflammopharmacology | Ausgabe 5/2019

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Abstract

Background

The oral administration of drug β-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 β-d-mannuronic acid as a new highly safe and efficient drug in the treatment of RA.

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Titel: International multicenter randomized, placebo-controlled phase III clinical trial of β-d-mannuronic acid in rheumatoid arthritis patients
verfasst von: Zahra Rezaieyazdi
Abid Farooqi
Hossein Soleymani-Salehabadi
Arman Ahmadzadeh
Mona Aslani
Saiedeh Omidian
Arezoo Sadoughi
Zohreh Vahidi
Mandana Khodashahi
Shazia Zamurrad
Seyed Shahabeddin Mortazavi-Jahromi
Hossein Fallahzadeh
Mostafa Hosseini
Zahra Aghazadeh
Parvin Ekhtiari
Hidenori Matsuo
Bernd H. A. Rehm
Salvatore Cuzzocrea
Antimo D’Aniello
Abbas Mirshafiey
Publikationsdatum: 02.01.2019
Verlag: Springer International Publishing
Erschienen in: Inflammopharmacology / Ausgabe 5/2019
Print ISSN: 0925-4692
Elektronische ISSN: 1568-5608
DOI: https://doi.org/10.1007/s10787-018-00557-2

Springer Medizin

Abstract

Background

Method

Results

Conclusion

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