EUCTR2013-000342-19-NL进行中（未招募）1 期
MULTI-CENTER, OPEN LABEL, SINGLE ARM PHASE IIIB STUDY ON SAFETY AND EFFICACY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) IN MONOTHERAPY OR IN COMBINATION WITH METHOTREXATE (MTX) OR OTHER NON-BIOLOGIC DISEASE MODIFYING ANTIRHEUMATIC DRUGS (DMARDS) IN RHEUMATOID ARTHRITIS PATIENTS WITH AN INADEQUATE RESPONSE TO NON-BIOLOGIC DMARDS - OSCAR
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients must meet the following criteria for study entry:
- •1. Able and willing to give written informed consent and comply with the requirements of the study protocol.
- •2. Patients at least 18 years of age.
- •3. Patients with a diagnosis of active RA according to the revised (1987) ACR criteria or EULAR/ACR (2010) criteria.
- •4. Oral corticosteroids (=10 mg/day prednisone or equivalent) and NSAIDs (up to the maximum recommended dose) are permitted if on a stable dose regimen for =4 weeks prior to Baseline.
- •5. Permitted non-biologic DMARDs are allowed if at a stable dose for at least 4 weeks prior to Baseline.
- •6. Receiving treatment on an outpatient basis, not including TCZ.
- •7. Females of childbearing potential and males with female partners of childbearing potential may participate in this study only if using a reliable means of contraception (e.g., physical barrier [patient or partner], contraceptive pill or patch, spermicide and barrier, or intrauterine device) during the study and for at least 3 months following the last dose of TCZ.
- •8. If female of childbearing potential, the patient must have a negative pregnancy test at the Screening and Baseline visits.
- •9. Patients that are conventional DMARD inadequate responders (IR), or are biological DMARD-IR with a maximum of an inadequate response to not more than one biological DMARD.
- •10. Have moderate to severe RA (DAS28 = 3.2, = 1 swollen joint).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 150
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •A patient will be excluded if the answer to any of the following statements is yes”:
- •1. Major surgery (including joint surgery) within 8 weeks prior to Screening or planned major surgery within 6 months following baseline.
- •2. Rheumatic autoimmune disease other than RA, including systemic lupus erythematosis, mixed connective tissue disorder, scleroderma, polymyositis, or significant systemic involvement secondary to RA (e.g., vasculitis, pulmonary fibrosis or Felty’s syndrome). Secondary Sjögren’s syndrome with RA is permitted.
- •3. Functional Class IV as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis.
- •4. Diagnosis of juvenile idiopathic arthritis or juvenile RA and/or RA before the age of 16.
- •5. Prior history of or current inflammatory joint disease other than RA (e.g., gout, Lyme disease, seronegative spondyloarthropathy including reactive arthritis, psoriatic arthritis, and arthropathy of inflammatory bowel disease).
- •6. Patients with lack of peripheral venous access.
- •Excluded Previous or Concomitant Therapy:
- •7. Exposure to TCZ (either intravenous [IV] or SC) at any time prior to Baseline.
- •8. Treatment with any investigational agent within 4 weeks (or five half-lives of the investigational drug, whichever is longer) of Screening.
- •9. Previous treatment with any cell-depleting therapies, including investigational agents or approved therapies, some examples are CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti CD19, and anti-CD20.
- •10. Treatment with IV gamma globulin, plasmapheresis within 6 months of Baseline.
- •11. Treatment with more than one biologic DMARD
- •12. Intraarticular or parenteral corticosteroids within 4 weeks prior to Baseline.
- •13. Immunization with a live/attenuated vaccine within 4 weeks prior to Baseline.
- •14. Any previous treatment with alkylating agents such as chlorambucil, or with total lymphoid irradiation.
- •Exclusions for General Safety:
- •15. History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies.
- •16. Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine (including uncontrolled diabetes mellitus), or gastrointestinal (GI) disease.
- •17. History of diverticulitis, diverticulosis requiring antibiotic treatment, or chronic ulcerative lower GI disease such as Crohn’s disease, ulcerative colitis, or other symptomatic lower GI conditions that might predispose to perforation.
- •18. Known active current or history of recurrent bacterial, viral, fungal, mycobacterial, or other infections (including but not limited to tuberculosis [TB] and atypical mycobacterial disease, hepatitis B and C, and herpes zoster, but excluding fungal infections of nail beds).
- •19. Any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of Screening or oral antibiotics within 2 weeks of Screening.
- •20. Active TB requiring treatment within the previous 3 years. Patients should be screened for latent TB and, if positive, treated following local practice guidelines prior to initiating TCZ. Patients treated for TB with no recurrence in 3 years are permitted.
- •21. Current liver disease as determined by the Investigator.
- •22. Positive hepatitis B surface antigen or hepatitis C antibody.
- •23. Primary or secondary immunodeficiency (history of or currently active).
- •24. Evidence of active malignant disea
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