KCT0000894
Recruiting
未知
A phase IIa, randomized, open-label study evaluating the safety and efficacy of CreaVax-RA combined with traditional disease modifying anti-rheumatic drugs (DMARDs) therapy in patients with moderate to severe active rheumatoid arthritis despite DMARDs therapy
JW CreaGene0 sites18 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Diseases of the musculo-skeletal system and connective tissue
- Sponsor
- JW CreaGene
- Enrollment
- 18
- Status
- Recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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