NCT01815411

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 21, 2013

Completed
3.1 years until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

April 6, 2018

Status Verified

June 1, 2016

Enrollment Period

1.8 years

First QC Date

March 14, 2013

Last Update Submit

April 4, 2018

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid arthritissymptom scorefatiguelife qualitycytokinesmRNA expressionQuality of LifeSigns and SymptomsIndication for Modification of Patient Physical Status

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Cytokine levels in harvested blood from the patients

    The duration of the experiment is 3 weeks (21 days)

Other Outcomes (1)

  • Life quality (SF-36)

    The duration of the experiment is 3 weeks (21 days)

Study Arms (2)

Mushroom extract

EXPERIMENTAL

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

Control group

NO INTERVENTION

The control group is selected by randomisation.

Interventions

Mushroom extractDIETARY_SUPPLEMENT

The mushroom extract (Andosan) is given orally in doses 30 m x 2 daily for 21 days

Mushroom extract

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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) \[11, 12\].

You may not qualify if:

  • Lack of cooperativity.
  • Clinically significant chronic infection, including positive serology for hepatitis B or C, history of positive HIV status.
  • Clinically significant malignancy .
  • Drug addiction
  • Any inflammatory disease of permanence not related to RA.
  • Vaccination during the trial.
  • Pregnancy or breast-feeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lillehammer Hospital for Rheumatic Diseases

Lillehammer, 2609, Norway

Location

Related Publications (3)

  • Johnson E, Forland DT, Hetland G, Saetre 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.

    PMID: 22564240BACKGROUND

  • Forland 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.

    PMID: 21129005BACKGROUND

  • 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.

    PMID: 21912538BACKGROUND

MeSH Terms

Conditions

Arthritis, RheumatoidFatigueSigns and Symptoms

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesPathological Conditions, Signs and Symptoms

Study Officials

  • Egil Johnson, Md, PhD

    Dep. of gastric- and pediatric surgery, Oslo University Hospital, Ulleval, Kirkeveien 166, 0407 Oslo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
consultant, professor

Study Record Dates

First Submitted

March 14, 2013

First Posted

March 21, 2013

Study Start

May 1, 2016

Primary Completion

March 1, 2018

Study Completion

April 1, 2018

Last Updated

April 6, 2018

Record last verified: 2016-06

Locations

NO(1)