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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

Status Approved

  • First Submitted Date


  • Registered Date


  • Last Updated Date


CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    Registration Number
    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
    MFDS Regulated Study Yes
    IND/IDE Protocol Yes
    Registered at Other Registry No
    Healthcare Benefit Approval Status
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    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 Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Sang-cheol Bae
    Title MD
    Telephone +82-2-2290-9200
    Affiliation Hanyang University Seoul Hospital
    Contact Person for Public Queries
    Name Sang-cheol Bae
    Title MD
    Telephone +82-2-2290-9200
    Affiliation Hanyang University Seoul Hospital
    Contact Person for Updating Information
    Name Minkyu Heo
    Title Manager
    Telephone +82-2-840-6906
    Affiliation JW CreaGene
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    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

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Korea Health Industry Development Institute
    Organization Type Government
    Project ID A110054
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name JW CreaGene
    Organization Type Pharmaceutical Company
  • 7. Study Summary

    Study Summary Information
    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.
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
    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


    Arm Type


    Arm Description

    Active rheumatoid arthritis patients modulated with usual DMARDs
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (M00-M99)Diseases of the musculoskeletal system and connective tissue 
       (M05.99)Seropositive rheumatoid arthritis, unspecified, site unspecified 
    Rare Disease No
    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
    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)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome /Safety/Efficacy
    Primary Outcome(s) 1
    adverse event & clinical test results
    treatment period
    Primary Outcome(s) 2
    Tolerated Dose
    4 weeks later after the last injection
    Secondary Outcome(s) 1
    Induction of antigen specific immune suppression for rheumatoid arthritis
    Before the first injection(W0), W8, W14
    Secondary Outcome(s) 2
    ACR20/50/70 Response Rate
    treatment period
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement Not provided at time of Registration
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