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International multicenter randomized, placebo-controlled phase III clinical trial of β-d-mannuronic acid in rheumatoid arthritis patients.
- Source :
- Inflammopharmacology; Oct2019, Vol. 27 Issue 5, p911-921, 11p
- Publication Year :
- 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. [ABSTRACT FROM AUTHOR]
- Subjects :
- ABATACEPT
RHEUMATOID arthritis
ORAL medication
CLINICAL trials
Subjects
Details
- Language :
- English
- ISSN :
- 09254692
- Volume :
- 27
- Issue :
- 5
- Database :
- Complementary Index
- Journal :
- Inflammopharmacology
- Publication Type :
- Academic Journal
- Accession number :
- 138793340
- Full Text :
- https://doi.org/10.1007/s10787-018-00557-2