EUCTR2008-007180-16-NL进行中（未招募）不适用
INFLUENCE OF B CELL DEPLETION BY MONOCLONAL ANTI-CD20 ANTIBODIES IN SYSTEMIC SCLERODERMA - RItuximab In Scleroderma ( RITIS)
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- MC
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
- •1. Age between 18 and 70 years.
- •2. Established diagnosis of systemic sclerosis according to ARA-criteria (appendix).
- •3. Informed consent
- •Appendix . Definition and classification of systemic sclerosis
- •Systemic sclerosis can be classified according to criteria set up by the American Rheumatism Association:
- •ARA scleroderma criteria cooperative study: Preliminary criteria for the classifica¬tion of
- •syste¬mic sclerosis (scleroderma)
- •_____________________________________________________________________
- •1. Major criterion:- Proximal scleroderma
- •2. Minor criteria :- Sclerodactyly
- •- Digital pitting scars or loss of substance of the digital finger pad
- •- Bibasilar pulmonary fibrosis
- •One major or two or more minor criteria are necessary to establish a diagnosis of SSc. A further subclas¬sification can be made in limited (cuta¬neous) SSc (lSSc) and diffuse (cutaneous) SSc (dSSc).
- •Limited SSc is characterized by skin involvement limited to hands, feet, face and/or fore¬arms, is associ¬ated with a high incidence of anticentro¬mere autoantibodies (70-80%), the existen¬ce for years of Ray¬naud's phenomenon and a significant late incidence of pulmonary hyper¬tensi¬on. The acronym CREST (Ca¬lcinosis, Raynaud's phenom¬enon, Esophageal dysmo¬tility, Sclero¬dac¬tyly and Telean¬giectasia) fits into this subclassification.
- •Diffuse SSc is characterized by skin involvement on upperarms and trunk, is as¬sociated with an early incidence of interstitial lung disease, hypertensive crisis and renal failure, diffuse gastrointesti¬nal disease and myocardial involvement.
- •Subcommittee for scleroderma criteria of the American Rheumatism Association diagnostic and therapeutic criteria commit¬tee. Preliminary criteria for the classification of systemic sclerosis (scleroderma). Arthritis Rheum 1980;23:581-590.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •. Pregnancy or unwillingness to use adequate contraception during study
- •2. Previous treatments with biological agents, cell depleting therapies including investigational
- •3. Significant exposure to bleomycin, tainted rapeseed oil, vinyl chloride, trichlorethylene or silica; eosinophilic myalgia syndrome; eosinophilic fasciitis.
- •5. History of allergic or anaphylactic reaction to a biological agent or known hypersensitivity to any component of anti-CD20 monoclonal antibodies or to murine proteins.
- •6. History of deep tissue infection (e.g. Fasciitis, abscess, osteomyelitis) within 1 year prior to baseline.
- •7. History of serious chronic or recurrent infection within 12 weeks prior to baseline, including HIV, HTLV-1,2 positivity.
- •8. History of cancer, including solid tumors, hematological malignancies and carcinoma in situ (except for basal cell and squamous cell carcinoma of the skin that have been treated and cured).
- •9. Concurrent liver failure as defined by a sustained 3-fold increase in serum transaminase or bilirubin.
- •10. Active drug or alcohol abuse or persistent psychiatric disorders that prevent inclusion.
- •11. Uncontrolled hypertension.
- •12. Poor compliance of the patient as assessed by the referring physicians.
- •13. Receipt of any vaccine 28 days prior to baseline.
- •14. Intolerance or contraindications to IV glucocorticoids.
- •15. Positive tests for HbsAg, Hepatitis core antibody or hepatitis C serology.
- •16. Concentrations of serum IgG and /or IgM below 5.0 and 0.40 mg/ mL.
- •17. Absolute neutrophil count of less than 1.0x 109/L.
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