Rheumatoid arthritis (RA)
Conditions
Interventions
Patients receive milk antibody administration for 12 weeks with the concurrent treatments at a dose of 0mg/man/day (placebo).
Patients receive milk antibody administration for 12 weeks with the con
Sponsors
Katayama Orthopedic Rheumatology Clinic
Abe Clinic Internal Medicine Uda clinic of Rheumatism Fukuyama Asama Chemical Co. Ltd Chondrex Inc. Seien Drug Compounding
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with RA whose disease activity were uncontrolled by authentic medications due to drug resistance or complications and risk factors.
Exclusion criteria
Exclusion criteria: Patients with milk allergy and those who are treated with biologic agents
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ACR response criteria, EULAR response criteria using the 28-joints counts disease activity score using ESR (DAS28-ESR) and newly established evaluation points by modifying ACR criteria. | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood levels of TNF, IL-1b, IL-6, IL-17, MIP-1b, CD4, LPB and LPS, immune complex, D-lactic acid, diamine oxidase, etc. Antibodies to type 2 collagens, LPS and PG-PS. Fecal LPS level and bacterial counts of total bacteria, E. coli, Bacteroides fragilis, Cl. perfringens, Lactobacillus and Bifidobacteria, etc. HLA typing for HLA-DR. | — |
Countries
Japan
Contacts
Public ContactKou Katayama
Katayama Orthopedic Rheumatology Clinic Department of orthopedic surgery
Outcome results
None listed