Evidence map›Paper›PMID 30604197›Full record

Trial reportInflammopharmacology2019

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

Zahra Rezaieyazdi, Abid Farooqi, Hossein Soleymani-Salehabadi, Arman Ahmadzadeh, Mona Aslani, Saiedeh Omidian, Arezoo Sadoughi, Zohreh Vahidi, Mandana Khodashahi, Shazia Zamurrad and 10 more

Abstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Inflammopharmacology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
2.4field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 17 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. Article
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors at 8 institutions in 4 countries.

Zahra RezaieyazdiRheumatic Diseases Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.ORCID http://orcid.org/0000-0001-8731-7999
Abid FarooqiDepartment of Rheumatology, Pakistan Institute of Medical Sciences, Islamabad, Pakistan.
Hossein Soleymani-SalehabadiDepartment of Rheumatology, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
Arman AhmadzadehDepartment of Rheumatology, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.ORCID http://orcid.org/0000-0003-3607-0118
Mona AslaniDepartment of Immunology, School of Public Health, Tehran University of Medical Sciences, Box: 14155-6446, Tehran, Iran.
Saiedeh OmidianDepartment of Immunology, School of Public Health, Tehran University of Medical Sciences, Box: 14155-6446, Tehran, Iran.
Arezoo SadoughiDepartment of Immunology, School of Public Health, Tehran University of Medical Sciences, Box: 14155-6446, Tehran, Iran.
Zohreh VahidiInflammation and Inflammatory Diseases Research Center, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.
Mandana KhodashahiRheumatic Diseases Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.ORCID http://orcid.org/0000-0003-1198-1783
Shazia ZamurradDepartment of Rheumatology, Pakistan Institute of Medical Sciences, Islamabad, Pakistan.
Seyed Shahabeddin Mortazavi-JahromiDepartment of Immunology, School of Public Health, Tehran University of Medical Sciences, Box: 14155-6446, Tehran, Iran.ORCID http://orcid.org/0000-0001-8786-4669
Hossein FallahzadehResearch Center of Prevention and Epidemiology of Non-Communicable Disease, Departments of Biostatistics and Epidemiology, Faculty of Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
Mostafa HosseiniDepartment of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.
Zahra AghazadehDepartment of Immunology, School of Public Health, Tehran University of Medical Sciences, Box: 14155-6446, Tehran, Iran.
Parvin EkhtiariDepartment of Immunology, School of Public Health, Tehran University of Medical Sciences, Box: 14155-6446, Tehran, Iran.
Hidenori MatsuoNagasaki National Hospital, Sakuragi-cho 6-41, Nagasaki, Japan.ORCID http://orcid.org/0000-0002-4619-9874
Bernd H A RehmCentre for Cell Factories and Biopolymers, Griffith Institute for Drug Discovery, Griffith University, Nathan, QLD, Australia.
Salvatore CuzzocreaDepartment of Chemical, Biological, Pharmaceutical and Environmental Sciences, University of Messina, Messina, Italy.ORCID http://orcid.org/0000-0001-6131-3690
Antimo D'AnielloLaboratory of Neurobiology, Zoological Station of Naples "Anton Dohrn", Villa Comunale, Naples, Italy.ORCID http://orcid.org/0000-0003-1675-5558
Abbas MirshafieyDepartment of Immunology, School of Public Health, Tehran University of Medical Sciences, Box: 14155-6446, Tehran, Iran. mirshafiey@tums.ac.ir.ORCID http://orcid.org/0000-0003-1996-2747
Tehran University of Medical Sciences · IRMashhad University of Medical Sciences · IRPakistan Institute of Medical Sciences · PKShahid Sadoughi University of Medical Sciences and Health Services · IRGriffith University · AUShahid Beheshti University of Medical Sciences · IRStazione Zoologica Anton Dohrn · ITUniversity of Messina · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe 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.

methodPatients (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.

resultsIn 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.

conclusionThe 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.

Indexed as

Antibodies, MonoclonalAntirheumatic AgentsArthritis, RheumatoidDouble-Blind MethodFemaleHexuronic AcidsHumansMaleMiddle AgedSeverity of Illness IndexTreatment OutcomeAntibodies, MonoclonalAntirheumatic AgentsHexuronic Acidsmannuronic acidClinical III trialDMARDsM2000Mannuronic acidNSAIDsRheumatoid arthritis

Identifiers

PMID30604197
OpenAlexW2908031818

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.