The therapeutic effects of ß-D-Mannuronic acid in patients with Rheumatoid Arthritis

Conditions

Rheumatoid Arthritis. Seropositive Rheumatoid Arthritis

Mozhgan Jahanbakhshi, Zohreh Babaloo, Seyed Shahabeddin Mortazavi‐Jahromi, Maryam Monsef Shokri, Hossein Ahmadi et al. (6 authors)

Endocrine Metabolic & Immune Disorders - Drug Targets2018-08-288 citations

10.2174/1871530318666180418111354

Targeting of circulating Th17 cells by β-D-mannuronic acid (M2000) as a novel medication in patients with rheumatoid arthritis.

Ahmadi H, Mahmoudi M, Gharibdoost F, Vojdanian M, Jamshidi AR, Fattahi MJ, Aghazadeh Z, Barati A, Mirshafiey A.

2017-10-239 citations

10.1007/s10787-017-0410-8

Effects of &beta;-D-mannuronic acid, as a novel non-steroidal anti-inflammatory medication within immunosuppressive properties, on IL17, ROR&gamma;t, IL4 and GATA3 gene expressions in rheumatoid arthritis patients

Anis Barati, Ahmadreza Jamshidi, Hossein Ahmadi, Zahra Aghazadeh, Abbas Mirshafiey

Drug Design Development and Therapy2017-03-0126 citations

10.2147/dddt.s129419

The Potent Inhibitory Effect of β-D-Mannuronic Acid (M2000) as a Novel NSAID with Immunosuppressive Property on Anti-Cyclic Citrullinated Peptide Antibodies, Rheumatoid Factor and Anti-dsDNA Antibodies in Patients with Rheumatoid Arthritis.

Ahmadi H, Jamshidi AR, Mahmoudi M, Cuzzocrea S, Fattahi MJ, Barati A, Rehm BHA, Matsuo H, Mirshafiey A.

2017-01-019 citations

10.2174/1570163814666170321113059

Interventions

Intervention 1: Treatment group will receive 1500 mg/day (three 500 mg tablets/day) of ß-D Mannuronic acid orally for 12 weeks. Intervention 2: Control group will receive immunosuppressive drugs orall

Treatment - Drugs

Treatment group will receive 1500 mg/day (three 500 mg tablets/day) of ß-D Mannuronic acid orally for 12 weeks.

Control group will receive immunosuppressive drugs orally for 12 weeks

Eligibility

Sex/Gender

All

Age

25 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria: 25-60 years old patients diagnosed with RA according to American College of Rheumatology Diagnostic Criteria after the initial visit by a specialist in rheumatology and parameters ESR, RF, CRP and Anti-CCP elected. Also each patient must sign written informed consent. Exclusion Criteria: History of fever and infectious diseases, positive pregnancy test or lactation, other collagen- vascular diseases, other auto-immune diseases, malignancies, patients have enrolled another Clinical Trial study within last 4 weeks, other concomitant diseases (Hepatic, renal, haematological, gastrointestinal, endocrine, cardiovascular, pulmonary, neurological or cerebral disease)

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Severity of disease. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Taking history and Questionnaire.;Morning stiffness. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Taking history and Questionnaire.;The number of swollen joints. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Examination.;Pain. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Examination.	—

Measure

Time frame

Severity of disease. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Taking history and Questionnaire.;Morning stiffness. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Taking history and Questionnaire.;The number of swollen joints. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Examination.;Pain. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Examination.

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Secondary

Measure	Time frame
Serum level of CRP. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Turbidometry.;The frequency of circulating Th17 cells. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Flow cytometry.;The frequency of circulating regulatory T (Treg) cells. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Flow cytometry.;L- selectin expression. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Flow cytometry.;LFA-1 expression. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Real-time PCR.;Serum level of IL-6. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Elisa.;Serum level of IL-10. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Elisa.;Serum level of IL-17A. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Elisa.;Serum level of TNF-a. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Elisa.;Erythrocyte Sedimentation Rate (ESR). Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Millimeters per hour.;Anti-cyclic Citrullinated Peptide (anti-CCP) Antibodies. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Serological tests.;Rheumatoid factor (RF). Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Serological tests.	—

Measure

Time frame

Serum level of CRP. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Turbidometry.;The frequency of circulating Th17 cells. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Flow cytometry.;The frequency of circulating regulatory T (Treg) cells. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Flow cytometry.;L- selectin expression. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Flow cytometry.;LFA-1 expression. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Real-time PCR.;Serum level of IL-6. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Elisa.;Serum level of IL-10. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Elisa.;Serum level of IL-17A. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Elisa.;Serum level of TNF-a. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Elisa.;Erythrocyte Sedimentation Rate (ESR). Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Millimeters per hour.;Anti-cyclic Citrullinated Peptide (anti-CCP) Antibodies. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Serological tests.;Rheumatoid factor (RF). Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Serological tests.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Abbas Mirshafiey

Department of Pathobiology, School of Public Health, Tehran University of Medical Sciences

mirshafiey@tums.ac.ir+98 21 8895 4913

Outcome results

None listed