None listed
Conditions
Interventions
Drug : Investigational Product: CreaVax-RA
- Dosage: First test dosage (A) 5 x 10^6 cells/injection
Next level dosage (B) 1.5 x 10^7 cells/injection
- Freqeuncy: 3 injections every two wee
Sponsors
JW CreaGene
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient diagnosed that he/she is with rheumatoid arthritis according to ACR rheumatoid arthritis classification standard reformed in 1987. 2. Patient is over 19 and under 71 years old. 3. Patient of who rheumatoid arthritis functional status is classified as Class I, II. III according to ACR classification standard. 4. Patient is with benign Anti CCP found by screening. 5. Patient of who ESR (Erythrocyte Sedimentation Rate) = 28 mm/hour or CRP (C-reactive Protein) = 1.0 mg/dL found by screening 6.Patient taking non-biological DMARDs such as MTX with the same quantity before screening for more than 8 weeks and this treatment can be applied for the time being. 7. Patient taking oral corticosteroid (prednisone of which amount used is 10mg/day or less) and NSAIDs before screening for more than 4 weeks. 8. Patient agreed to contracept until 6months after the clinical trial. 9. Patient participates in the clinical trial voluntarily signing up.
Exclusion criteria
Exclusion criteria: 1. Patient had major surgery such as joint surgery within 8 weeks before screening 2. Patient is currently with rheumatoid arthritis or rheumatoid autoimmune disease 3. Patient is with serious rheumatoid arthritis complication. 4. Patient is with rheumatoid arthritis Class IV according to ACR classification 5. Patient is currently with or had inflammatory joint disease other than arthritis. 6. Child patient is with rheumatoid arthritis. 7. Patient is in wash out period after taking the medicine before screening. 8. Patient took immunosuppressant within 3 months registration. 9. Patient took such treatments as V-globulin IV, Plasmapheresis and Prosorba within 24 weeks 10. Patient took other clinical trial medicines within 12 weeks 11. Patient is with serious cardiovascular system, nervous system, respiratory system, endocrine system and gastrointestinal system related disease cannot be controlled. 12. Patient is with serious high blood pressure. 13. Patient could be with renal, liver and biliary tract function disorder. 14. Patient with serious asthma, psoriasis, Inflammatory bowel disease cannot be controlled. 15. Patient is currently with gastric ulcer, ulcerative stomatitis, ulcerative colitis 16. Patient is currently with Bacterial, viral, fungal, mycobacterial other infectious diseases 17. Patient is reluctant to have treatment of latent tuberculosis found by screening 18. Patient needs to be hospitalized due to infection diseases, had antibiotics administration in the vein 4 weeks before screening or oral administration 2 weeks before screening. 19. Patient is currently with or had primary and secondary immunodeficiency syndrome. 20. Patient was prescribed as malignant tumor within a decade. 21. Pregnant woman, nursing woman or woman is going to be pregnant within 6 months. 22. Patient is judged by the P.I as the patient is not suitable for the research. 23. Serum creatinine > ULN/ 24. ALT or AST > 1.5 times of ULN.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| adverse event & clinical test results;Tolerated Dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Induction of antigen specific immune suppression for rheumatoid arthritis;ACR20/50/70 Response Rate | — |
Countries
Korea, Republic of
Contacts
Public ContactSang-cheol Bae
Hanyang University Seoul Hospital
Outcome results
None listed