Status:
COMPLETED
Effect of Andosan in Patients With Rheumatoid Arthritis
Lead Sponsor:
Egil Johnson
Collaborating Sponsors:
ImmunoPharma AS
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
19-75 years
Phase:
NA
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 suffere...
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 f...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2018
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01815411
Start Date
May 1 2016
End Date
April 1 2018
Last Update
April 6 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Lillehammer Hospital for Rheumatic Diseases
Lillehammer, Norway, 2609