Rheumatoid Arthritis Clinical Trial
Official title:
Effect of the Mushroom Extract Andosan on Symptoms and Inflammatory Parameters in Patients With Rheumatoid Arthritis (RA)
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04226131 -
MusculRA: The Effects of Rheumatoid Arthritis on Skeletal Muscle Biomechanics
|
N/A | |
Completed |
NCT04171414 -
A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis
|
Phase 3 | |
Completed |
NCT02833350 -
Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA)
|
Phase 2 | |
Completed |
NCT04255134 -
Biologics for Rheumatoid Arthritis Pain (BIORA-PAIN)
|
Phase 4 | |
Recruiting |
NCT05615246 -
Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty PMCF (HRP)
|
||
Completed |
NCT03248518 -
Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases
|
N/A | |
Completed |
NCT03514355 -
MBSR in Rheumatoid Arthritis Patients With Controlled Disease But Persistent Depressive Symptoms
|
N/A | |
Recruiting |
NCT06005220 -
SBD121, a Synbiotic Medical Food for RA Management
|
N/A | |
Recruiting |
NCT05451615 -
Efficacy and Safety of Abatacept Combined With JAK Inhibitor for Refractory Rheumatoid Arthritis
|
Phase 3 | |
Completed |
NCT05054920 -
Eccentric Versus Concentric Exercises for Rotator Cuff Tendinopathy in Patients With Rheumatoid Arthritis
|
N/A | |
Completed |
NCT02037737 -
Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting
|
N/A | |
Recruiting |
NCT04079374 -
Comparative Efficacy, Safety and Immunogenicity Study of Etanercept and Enbrel
|
Phase 3 | |
Completed |
NCT02504268 -
Effects of Abatacept in Patients With Early Rheumatoid Arthritis
|
Phase 3 | |
Recruiting |
NCT05496855 -
Remote Care in People With Rheumatoid Arthritis
|
N/A | |
Completed |
NCT05051943 -
A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
|
||
Recruiting |
NCT06103773 -
A Study of Single and Multiple Oral Doses of TollB-001
|
Phase 1 | |
Recruiting |
NCT06031415 -
Study of GS-0272 in Participants With Rheumatoid Arthritis or Systemic Lupus Erythematosus
|
Phase 1 | |
Completed |
NCT05999266 -
The Cartilage and Muscle Thickness on Knee Pain in Patients With Rheumatoid Arthritis
|
||
Recruiting |
NCT05302934 -
Evaluation of the PHENO4U Data Platform in Patients Undergoing Total Knee Arthroplasty
|
||
Recruiting |
NCT04169100 -
Novel Form of Acquired Long QT Syndrome
|
Phase 4 |