Status Approved
First Submitted Date
2010/09/01
Registered Date
2010/09/14
Last Updated Date
2013/07/04
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0000035 |
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Unique Protocol ID | CreaVax-RA-001 |
Public/Brief Title | A study to treat active rheumatoid arthritis using autologous dendritic cells |
Scientific Title | A phase I, open label, dose ranging study to evaluate the safety and tolerance of CreaVax-RA in active rheumatoid arthritis patients with usual DMARDs |
Acronym | |
MFDS Regulated Study | Yes |
IND/IDE Protocol | Yes |
Registered at Other Registry | No |
Healthcare Benefit Approval Status |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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Board Approval Number | HYUH IRB 2010-C-24 |
Approval Date | 2010-06-29 |
Institutional Review Board Name | Hanyang University Hospital Institutional Review Board |
Institutional Review Board Address | |
Institutional Review Board Telephone | |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
---|---|
Name | Sang-cheol Bae |
Title | MD |
Telephone | +82-2-2290-9200 |
Affiliation | Hanyang University Seoul Hospital |
Address | |
Contact Person for Public Queries | |
Name | Sang-cheol Bae |
Title | MD |
Telephone | +82-2-2290-9200 |
Affiliation | Hanyang University Seoul Hospital |
Address | |
Contact Person for Updating Information | |
Name | Minkyu Heo |
Title | Manager |
Telephone | +82-2-840-6906 |
Affiliation | JW CreaGene |
Address |
4. Status
Study Site | Single | |
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Overall Recruitment Status | Completed | |
Date of First Enrollment | 2010-10-15 Actual | |
Target Number of Participant | 12 | |
Primary Completion Date | 2012-08-31 , Actual | |
Study Completion Date | 2012-11-26 , Actual | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Hanyang University Seoul Hospital | |
Recruitment Status | Completed | |
Date of First Enrollment | 2010-10-15 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Korea Health Industry Development Institute |
Organization Type | Government |
Project ID | A110054 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | JW CreaGene |
Organization Type | Pharmaceutical Company |
7. Study Summary
Lay Summary | This research purports to check the safety, tolerance of non-biological DMARDs and to adjust the amount used observing local, general side effects can occur after injecting CreaVax-RA, is auto-derived dendritic cel, to patient is taking non-biological DMARDs for rheumatoid arthritis and to obtain data as to the effectiveness of the medicine observing specific antigen immunologic inhibition act on rheumatoid arthritis of the adjusted amount used. |
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8. Study Design
Study Type | Interventional Study |
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Study Purpose | Treatment |
Phase | Phase1 |
Intervention Model | Single Group |
Blinding/Masking | Open |
Allocation | Not Applicable |
Intervention Type | Drug |
Intervention Description | 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 weeks, after four weeks 2 injections every two weeks(W0, W2, W4, W8, W10) |
Number of Arms | 1 |
Arm 1 |
Arm Label CreaVax-RA Single Arm |
Target Number of Participant 12 |
|
Arm Type Experimental |
|
Arm Description Active rheumatoid arthritis patients modulated with usual DMARDs |
9. Subject Eligibility
Condition(s)/Problem(s) |
* (M00-M99)Diseases of the musculoskeletal system and connective tissue (M05.99)Seropositive rheumatoid arthritis, unspecified, site unspecified |
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Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 18Year~70Year |
|
Description 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 |
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. |
Healthy Volunteers | No |
10. Outcome Measure(s)
Type of Primary Outcome | /Safety/Efficacy | |
---|---|---|
Primary Outcome(s) 1 | ||
Outcome | adverse event & clinical test results |
|
Timepoint | treatment period |
|
Primary Outcome(s) 2 | ||
Outcome | Tolerated Dose |
|
Timepoint | 4 weeks later after the last injection |
|
Secondary Outcome(s) 1 | ||
Outcome | Induction of antigen specific immune suppression for rheumatoid arthritis |
|
Timepoint | Before the first injection(W0), W8, W14 |
|
Secondary Outcome(s) 2 | ||
Outcome | ACR20/50/70 Response Rate |
|
Timepoint | treatment period |
11. Study Results and Publication
Result Registered |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | Not provided at time of Registration |
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