A Phase 2a Study to evaluate efficacy and safety of CreaVax-RA in Combination With DMARDs, in Treatment of Patients With Rheumatoid Arthritis
- Conditions
- Diseases of the musculo-skeletal system and connective tissue
- Registration Number
- KCT0000894
- Lead Sponsor
- JW CreaGene
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 18
1. Subject is diagnosed with rheumatoid arthritis as determined by 2010 ACR/EULAR rheumatoid arthritis clasification criteria and has had rheumatoid arthritis for at least 6 months.
2. Subject is over 19 and under 71 years old.
3. Functional class I, II, III as defined by ACR classification of functional status in RA.
4. Subjects who are positive in at least one or more of antibody of auto-antigens (RA33, PAD4, c-FLG, Vimentin).
*The criteria to determine positivity for the test result is above average value of normal samples ELISA O.D x 1.5.
5. Subjects who have an inadequate response to alone or in combination with DMARDs(Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, tacrolimus) for at least 12 weeks.
6. Subject who positive in anti-CCP
7. Subject has active rheumatoid arthritis defined as = 4 tender joint count (out of 68 joint count) and = 4 swollen joint count (out of 66 joint count) and ESR (Erythrocyte Sedimentation Rate) = 28 mm/hour or CRP (C-reactive Protein) = 1.0 mg/dL
8. Subjects receiving a nonsteroidal anti-inflammatory drug (NSAID) and/or prednisone (10 or less mg day) must be on stable doses of these agents for more than 4 weeks.
9. Subject who consent to use contraception during the trial or for 6 months following end of study.
10. Subject who decide to participate in clinical trials and signed a consent form
1. Rheumatic autoimmune disease other than RA, including systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), scleroderma, polymyositis.
2. Subject is with serious rheumatoid arthritis complication (eg; vasculitis, pulmonary fibrosis or Felty's syndrome except Sjogren’s syndrome)
3. Functional class IV as defined by ACR classification of functional status in RA.
4. Subject must not have a disgnosis or history of any other inflammatory arthritis (eg, gout, reactive arthritis, psoriatic arthritis, Seronegative spondyloarthropathy or lyme disease)
5. Juvenile rheumatoid arthritis
6. Exclusion laboratory
Hemoglobin = 8.5 g/dL, WBC count = 3,000/mm^3, platelet = 50,000/uL
7. Systemic disease;
-Subject with an active malignancy of any type or a history of malignancy within 10 years. (except basal cell carcinoma of the skin that has been excised prior to study start)
-Subject with severe cardiovascular, digestive, respiratory, endocrine, hematologic, neurologic disease
-Subject who underwent major surgery within 8 weeks, including joint surgery.
-Durg abuse
-Subject with severe hypertension (SBP = 180 or DBP = 110 mmHg)
8. Subject took other clinical trial medicines within 12 weeks
9. Subject is in wash out period after taking the medicine before screening.
-Etanercept: = 2 weeks
-Infliximab, adalimumab: = 8 weeks
-Abatacept: = 12 weeks
-Rituximab: = 36 weeks
-Intra articular or parenteral corticosteroid = 6 weeks (IV or IM)
-Alkylating agents(eg; cyclophosphamide, chlorambucil) or total lymphoid irradiation: = 1 year
-Attenuated/live vaccine: = 4 weeks
10. Subject took immunosuppressant(eg Cyclosporin, azathiopurine) within 3 months registration.
11. Subject took such treatments as V-globulin IV, Plasmapheresis and Prosorba within 24 weeks
12. Subject could be with renal, liver and biliary tract function disorder.
13. Subject is reluctant to have treatment of latent tuberculosis found by screening
14. Subject is currently with Bacterial, viral, fungal, mycobacterial other infectious diseases, including Hepatitis B, C and HIV. Subject had antibiotics I.V administration within 4 weeks or oral administration 2 weeks before screening.
15. Female patients who are breast feeding, pregnant, or plan to become pregnant within 6 months.
16. Subject is currently with or had primary and secondary immunodeficiency syndrome.
17. Subject must not have any other condition which, in the investigator's judgement, would make them unsuitable for inclusion in the study
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of EULAR response using the DAS28
- Secondary Outcome Measures
Name Time Method Immune response;ACR20/50/70 Response Rate ;Safety