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Effect of Andosan in Patients With Rheumatoid Arthritis (Andosan-RA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01815411
Recruitment Status : Completed
First Posted : March 21, 2013
Last Update Posted : April 6, 2018
Sponsor:
Collaborator:
ImmunoPharma AS
Information provided by (Responsible Party):
Egil Johnson, Oslo University Hospital

Brief Summary:

Rheumatoid Arthritis (RA) is a chronic, autoimmune inflammatory disease that leads to significant pain, joint destruction and functional decline, and has a substantial economic impact both for sufferers and society. Although the etiology of RA is unknown, it is generally accepted that it arises from an interplay of genetic predisposition (in particular, HLA-DR allele subtypes and specific gene polymorphisms), immunological deregulation (e. g. autoantibody production), and environmental factors. The prevalence and incidence of RA in Norway is estimated to 0,4-0,5 % and 0,020-0,025 %, respectively, and incidence rates are 2-4-fold higher in women. Synovitis and bone resorption are key pathogenetic factors in RA and these patients have elevated cytokine levels in joints and blood (i.e. TNF, IL-1, IL-6). RA is also associated with significant comorbidity; the most important is premature cardiovascular disease that significantly contributes to increased mortality. Compared with the general population, mortality in RA is from 1,57-2,0-fold higher in Norway and Sweden, and their mean life expectancy is reduced by an average of 5-10 years. Medical treatment of RA consists of nonsteroidal anti-inflammatory drugs, systemic glucocorticosteroids, traditional disease modifying antirheumatic drugs (including methotrexate) and biologic therapies (including anti-tumor necrosis factor (TNF) α, anti-IL 6 and anti-CD20 therapy). Also, a considerable portion of the patients are in need of joint replacement surgery and in need of rehabilitation.

However, the treatment opportunities are still not optimal. In a large proportion of the patients, full control of the disease is not possible due to limited effect of available therapies and/or intolerance to these therapies. Therefore, there is a huge need to find new therapeutic alternatives to treat RA.

Since studies on healthy volunteers and IBD-patients support that the mushroom extract AndoSanTM exert an anti-inflammatory effect in vivo, the investigators wanted to examine in a pilot study whether this effect also was evident in patients with RA. A potential anti-inflammatory effect could prove beneficial in these seriously ill patients, who accordingly could experience less side effects (edema, granulocytopenia, diminished tissue repair) due to potential reduction number and dose of disease modifying drugs.


Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Dietary Supplement: Mushroom extract Not Applicable

Detailed Description:

Main aim: Examine whether daily oral ingestion of a immunomodulatory mushroom extract (AndoSanTM) leads to a clinical, biochemical and genetical improvement in RA. The experiment will be carried out for 21 days in 15 eligible RA patients. In order to increase the scientific value of the project we will use, a as far as possible, an age matched control group of RA patients with steady medication and no intervention. The control group of 10-15 patients will be answering the same questionnaires and give the same samples of blood and feces.

Partial aims: To compare prior to (day 0) and after (day 21) daily (30 ml x 2) ingestion of Andosan the effect of this therapy on:

  • general blood samples (leucocytes, CRP, liver and renal function tests), including erythrocyte sedimentation rate (SR) and pentraxin 3 (PTX3)
  • level of blood cytokines and analytes (IL-1α/-1ra/-2/-4/-5/-6/-7/-8/-9/-10/-12(p70)/-13/-15/ 17,G-CSF,GM-CSF,MCP-1,MIP-1ß/-1α,IFNγ,TNFα and basic FGF, eotaxin, PDGF-BB, RANTES,VEGF;27-plex) -level of inflammatory marker calprotectin in feces and blood in patients
  • genetic expression in blood leukocytes (microarray) -number of swollen and tender joints, morning stiffness, Disease activity score 28 calculated by ESR (DAS28-ESR), RA impact of disease score (RAID), Health Assessment Questionnaire (HAQ), visual analogue scale (VAS) for patient's and physician's global assessment of disease activity, life quality (SF-36 version 2), fatigue score.

Partial aims: To compare prior to (day 0) and after (day 21) daily (30 ml x 2) ingestion of Andosan the effect of this therapy on:

  • general blood samples (leucocytes, CRP, liver and renal function tests), including erythrocyte sedimentation rate (SR) and pentraxin 3 (PTX3)
  • level of blood cytokines and analytes (IL-1α/-1ra/-2/-4/-5/-6/-7/-8/-9/-10/-12(p70)/-13/-15/ 17,G-CSF,GM-CSF,MCP-1,MIP-1ß/-1α,IFNγ,TNFα and basic FGF, eotaxin, PDGF-BB, RANTES,VEGF;27-plex) -level of inflammatory marker calprotectin in feces and blood in patients
  • genetic expression in blood leukocytes (microarray) -number of swollen and tender joints, morning stiffness, Disease activity score 28 calculated by ESR (DAS28-ESR), RA impact of disease score (RAID), Health Assessment Questionnaire (HAQ), visual analogue scale (VAS) for patient's and physician's global assessment of disease activity, life quality (SF-36 version 2), fatigue score.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effect of the Mushroom Extract Andosan on Symptoms and Inflammatory Parameters in Patients With Rheumatoid Arthritis (RA)
Actual Study Start Date : May 2016
Actual Primary Completion Date : March 2018
Actual Study Completion Date : April 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mushroom extract
The patients are given the mushroom extract (Andosan) in doses 30 mlx2 per day for 1 days. The experimental group is selected by randomisation.
Dietary Supplement: Mushroom extract
The mushroom extract (Andosan) is given orally in doses 30 m x 2 daily for 21 days

No Intervention: Control group
The control group is selected by randomisation.



Primary Outcome Measures :
  1. Symptom score [ Time Frame: The duration of the experiment is 3 weeks (21 days) ]
    The symptom score will be registered at day 1 prior to the patients are given Andosan for 21 days, and at day 21 after the patients have consumed Andosan daily for 21 days.


Secondary Outcome Measures :
  1. Cytokine levels in harvested blood from the patients [ Time Frame: The duration of the experiment is 3 weeks (21 days) ]
    Cytokine levels will be measured at day 1 prior to ingestion of Andosan and at day 21 after 21 days of Andosan consumption.


Other Outcome Measures:
  1. Life quality (SF-36) [ Time Frame: The duration of the experiment is 3 weeks (21 days) ]
    The patients will be registerd for life quality prior to ingestion of Andosan at day 1 and at day 21 after daily ingestion of Andosan for 21 days.



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age>18 years
  • Able and willing to give written informed consent, and to comply with the requirements of the study protocol.
  • Fulfilling the ACR 1987 revised diagnostic criteria for the diagnosis rheumatoid arthritis.
  • Moderate disease activity based on the clinical evaluation including DAS28-ESR (DAS28 3.2-5.1) [11, 12].
  • Stable medication by disease modifying drugs (DMARDs) and systemic glucocorticosteroids for 3 months prior to the inclusion.

Exclusion Criteria:

  • Lack of cooperativity.
  • Clinically significant chronic infection, including positive serology for hepatitis B or C, history of positive HIV status.
  • Acute significant infection during the last 3 weeks before the inclusion. Surgery during the last 4 weeks before the inclusion, and during the study period.
  • Clinically significant malignancy .
  • Drug addiction
  • Any inflammatory disease of permanence not related to RA.
  • Use of prednisolone >7,5 mg daily for 1 month prior to the inclusion.
  • Use of biologic treatment including antibodies to cytokines and their receptors for 6 weeks prior to the inclusion.
  • Use of intramuscular, intra-articular or intravenous injections of corticosteroids during or within 4 weeks prior to inclusion in the trial.
  • Vaccination during the trial.
  • Pregnancy or breast-feeding.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01815411


Locations
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Norway
Lillehammer Hospital for Rheumatic Diseases
Lillehammer, Norway, 2609
Sponsors and Collaborators
Egil Johnson
ImmunoPharma AS
Investigators
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Principal Investigator: Egil Johnson, Md, PhD Dep. of gastric- and pediatric surgery, Oslo University Hospital, Ulleval, Kirkeveien 166, 0407 Oslo
Publications:
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Responsible Party: Egil Johnson, consultant, professor, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01815411    
Other Study ID Numbers: 2012/1962
Egil Johnson ( Other Identifier: Dep. of gastroenterological- and pediatric surgery, Ulleval )
First Posted: March 21, 2013    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: June 2016
Keywords provided by Egil Johnson, Oslo University Hospital:
Rheumatoid arthritis
symptom score
fatigue
life quality
cytokines
mRNA expression
Quality of Life
Signs and Symptoms
Indication for Modification of Patient Physical Status
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases