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A randomized controlled trial comparing the effects of β-D-Mannuronic acid and immunosuppressive drugs on disease activity and inflammatory markers in patients with Rheumatoid Arthritis

Protocol summary

Summary
Following to get an official approval for assessment of therapeutic effect of β-D-Mannuronic acid on Ankylosing Spondylitis with the Irct registration number : IRCT2013062213739N1 at the level of Clinical Trial Phase І from Ministry of Iranian Health and Medical Education, a Clinical Trial of this drug was designed in patients with Rheumatoid Arthritis. The aim of this study is to assess the safety and effectiveness of β-D Mannuronic acid in patients with Rheumatoid Arthritis. β-D-Mannuronic acid an anti-inflammatory agent that belongs to the family of nonsteroidal anti-inflammatory drugs. This drug has shown therapeutic effects with the greatest tolerability and safety in various experimental models such as experimental model of MS, rheumatoid arthritis, nephrotic syndrome and acute glomerulonephritis. In this randomized, controlled trial, thirty five patients with Rheumatoid Arthritis fulfilling the American College of Rheumatology Diagnostic Criteria that have active disease will be examined. Additionally, patients do not have other concomitant diseases (Hepatic, renal and cardiovascular) or malignancies. Written informed consent will be obtained. Patients will be randomly assigned to receive either β-D Mannuronic acid (treatment group, 25 patients) 1500 mg/day (three 500 mg tablets/day) or immunosuppressive drugs (control group, 10 patients) orally for 12 weeks. Medical history, clinical parameters , serum level of CRP, ESR, RF,Anti CCP and also the frequencies of circulating Th17 cells and regulatory T cells, L- selectin expression and leukocyte function-associated antigen-1 (LFA-1) expression will be evaluated at baseline and 12 weeks after treatment.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014011213739N2
Registration date: 2014-05-16, 1393/02/26
Registration timing: prospective

Last update:
Update count: 0
Registration date
2014-05-16, 1393/02/26
Registrant information
Name
Abbas Mirshafiey
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8895 4913
Email address
mirshafiey@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellor for Research, Tehran University of Medical Sciences and Rheumatology Research Center, Tehran University of Medical Sciences
Expected recruitment start date
2014-07-20, 1393/04/29
Expected recruitment end date
2015-07-20, 1394/04/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
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Scientific title
A randomized controlled trial comparing the effects of β-D-Mannuronic acid and immunosuppressive drugs on disease activity and inflammatory markers in patients with Rheumatoid Arthritis
Public title
The therapeutic effects of β-D-Mannuronic acid in patients with Rheumatoid Arthritis
Purpose
Basic scienece
Inclusion/Exclusion 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)
Age
From 25 years old to 60 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size: 35
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
1- In this study the patients and outcomes assessor do not know which β-D Mannuronic acid or immunosuppressive drugs is being given (double-blind). 2- In this study randomization will be performed by stratified randomization method. 3- β-D Mannuronic acid was extracted from Alginic acid sodium salt (Sigma, A2033-1Kg) as a reference sample. This extraction method is a modified procedure of acid hydrolysis method (Chhatbar et al. 2009) that is being performed in Department of Pathobiology, Division of Immunology , School of Public Health, Tehran University of Medical Sciences.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
6th floor, Headquarter for Tehran University of Medical Sciences, on the corner of Keshavarz Blvd. And Qods Street, Keshavarz Blvd., Tehran, Iran.
City
Tehran
Postal code
Approval date
2014-01-15, 1392/10/25
Ethics committee reference number
130/2392/د/92

Health conditions studied

1

Description of health condition studied
Rheumatoid Arthritis
ICD-10 code
M05
ICD-10 code description
Seropositive Rheumatoid Arthritis

Primary outcomes

1

Description
Severity of disease
Timepoint
At baseline and after 12 weeks of treatment
Method of measurement
Taking history and Questionnaire

2

Description
Morning stiffness
Timepoint
At baseline and after 12 weeks of treatment
Method of measurement
Taking history and Questionnaire

3

Description
The number of swollen joints
Timepoint
At baseline and after 12 weeks of treatment
Method of measurement
Examination

4

Description
Pain
Timepoint
At baseline and after 12 weeks of treatment
Method of measurement
Examination

Secondary outcomes

1

Description
Serum level of CRP
Timepoint
At baseline and after 12 weeks of treatment
Method of measurement
Turbidometry

2

Description
The frequency of circulating Th17 cells
Timepoint
At baseline and after 12 weeks of treatment
Method of measurement
Flow cytometry

3

Description
The frequency of circulating regulatory T (Treg) cells
Timepoint
At baseline and after 12 weeks of treatment
Method of measurement
Flow cytometry

4

Description
L- selectin expression
Timepoint
At baseline and after 12 weeks of treatment
Method of measurement
Flow cytometry

5

Description
LFA-1 expression
Timepoint
At baseline and after 12 weeks of treatment
Method of measurement
Real-time PCR

6

Description
Serum level of IL-6
Timepoint
At baseline and after 12 weeks of treatment
Method of measurement
Elisa

7

Description
Serum level of IL-10
Timepoint
At baseline and after 12 weeks of treatment
Method of measurement
Elisa

8

Description
Serum level of IL-17A
Timepoint
At baseline and after 12 weeks of treatment
Method of measurement
Elisa

9

Description
Serum level of TNF-α
Timepoint
At baseline and after 12 weeks of treatment
Method of measurement
Elisa

10

Description
Erythrocyte Sedimentation Rate (ESR)
Timepoint
At baseline and after 12 weeks of treatment
Method of measurement
Millimeters per hour

11

Description
Anti-cyclic Citrullinated Peptide (anti-CCP) Antibodies
Timepoint
At baseline and after 12 weeks of treatment
Method of measurement
Serological tests

12

Description
Rheumatoid factor (RF)
Timepoint
At baseline and after 12 weeks of treatment
Method of measurement
Serological tests

Intervention groups

1

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

2

Description
Control group will receive immunosuppressive drugs orally for 12 weeks
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Rheumatology Research Center, Tehran University of Medical Sciences
Full name of responsible person
Dr. Mahdi Mahmoudi (PhD- Assistant Professor)
Street address
Rheumatology Research Center, Dr. Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-Chancellor for Research, Tehran University of Medical Sciences
Full name of responsible person
Dr. Masood Younesian (MD, PhD, Vice-Chancellor for Research, Tehran University of Medical Sciences)
Street address
6th floor, Headquarter for Tehran University of Medical Sciences, on the corner of Keshavarz Blvd. And Qods Street, Keshavarz Blvd. Tehran, Iran.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellor for Research, Tehran University of Medical Sciences
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

2

Sponsor
Name of organization / entity
Rheumatology Research Center, Tehran University of Medical Sciences
Full name of responsible person
Dr. Farhad Gharibdoost(MD, Professor)
Street address
Rheumatology Research Center, Dr. Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rheumatology Research Center, Tehran University of Medical Sciences
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Department of Pathobiology, School of Public Health, Tehran University of Medical Sciences
Full name of responsible person
Dr. Abbas Mirshafiey
Position
Head of the Department of Pathobiology (PhD - Professor)
Other areas of specialty/work
Street address
Department of Pathobiology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8895 4913
Fax
Email
mirshafiey@tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Department of Pathobiology, School of Public Health, Tehran University of Medical Sciences
Full name of responsible person
Dr. Abbas Mirshafiey
Position
Head of the Department of Pathobiology (PhD - Professor)
Other areas of specialty/work
Street address
Department of Pathobiology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8895 4913
Fax
Email
mirshafiey@tums.ac.ir
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
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Study Protocol
empty
Statistical Analysis Plan
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Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
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