Rheumatoid Arthritis Clinical Trial
— Andosan-RAOfficial title:
Effect of the Mushroom Extract Andosan on Symptoms and Inflammatory Parameters in Patients With Rheumatoid Arthritis (RA)
Verified date | June 2016 |
Source | Oslo University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | April 2018 |
Est. primary completion date | March 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years to 75 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Norway | Lillehammer Hospital for Rheumatic Diseases | Lillehammer |
Lead Sponsor | Collaborator |
---|---|
Egil Johnson | ImmunoPharma AS |
Norway,
Førland DT, Johnson E, Saetre L, Lyberg T, Lygren I, Hetland G. Effect of an extract based on the medicinal mushroom Agaricus blazei Murill on expression of cytokines and calprotectin in patients with ulcerative colitis and Crohn's disease. Scand J Immunol. 2011 Jan;73(1):66-75. doi: 10.1111/j.1365-3083.2010.02477.x. — View Citation
Hetland G, Johnson E, Lyberg T, Kvalheim G. The Mushroom Agaricus blazei Murill Elicits Medicinal Effects on Tumor, Infection, Allergy, and Inflammation through Its Modulation of Innate Immunity and Amelioration of Th1/Th2 Imbalance and Inflammation. Adv Pharmacol Sci. 2011;2011:157015. doi: 10.1155/2011/157015. Epub 2011 Sep 6. — View Citation
Johnson E, Førland DT, Hetland G, Sætre L, Olstad OK, Lyberg T. Effect of AndoSan™ on expression of adhesion molecules and production of reactive oxygen species in human monocytes and granulocytes in vivo. Scand J Gastroenterol. 2012 Sep;47(8-9):984-92. doi: 10.3109/00365521.2012.660544. Epub 2012 May 8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Life quality (SF-36) | 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. | The duration of the experiment is 3 weeks (21 days) | |
Primary | Symptom score | 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. | The duration of the experiment is 3 weeks (21 days) | |
Secondary | Cytokine levels in harvested blood from the patients | Cytokine levels will be measured at day 1 prior to ingestion of Andosan and at day 21 after 21 days of Andosan consumption. | The duration of the experiment is 3 weeks (21 days) |
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