International multicenter randomized, placebo-controlled phase III clinical trial of β-d-mannuronic acid in rheumatoid arthritis patients
- 02.01.2019
- Original Article
Erschienen in:
- 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
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.
Anzeige
- 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
Dieser Inhalt ist nur sichtbar, wenn du eingeloggt bist und die entsprechende Berechtigung hast.