EUCTR2015-000424-28-BE进行中（未招募）1 期
A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 210
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
入选标准
- •- Age>=18 years at baseline (Day 1)
- •- Diagnosis of SSc, as defined using the American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) criteria (2013)
- •- SSc disease duration of <=60 months (defined as time from the first non-Raynaud phenomenon manifestation)
- •- mRSS of >=10 and <=35 units at screening
- •- Active disease that meets at least one of the following criteria at screening: Disease duration of <=18 months defined as time from the first non-Raynaud phenomenon manifestation; Increase in mRSS of >=3 units compared with the most recent assessment performed within the previous 6 months; Involvement of one new body area and an increase in mRSS of >=2 units compared with the most recent assessment performed within the previous 6 months; Involvement of two new body areas within the previous 6 months; Presence of at least one tendon friction rub
- •- Presence of at least one of the following at screening: C reactive protein (CRP)>=0.6 milligrams (mg) per deciliter (dL) (>=6 mg/Liter [L]); erythrocyte sedimentation rate (ESR)>=28 millimeter per hour (mm/hr); Platelet count>=330 x 10^9/L (330,000/microliter)
- •- Uninvolved or mildly thickened skin at one of the following possible injection site locations: Front, middle region of the thigh; Abdomen, except for the 2-inch area directly around the navel; Outer area of the upper arm (if a patient caregiver is giving the injection)
- •- For women who are not postmenopausal (>=12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use single or combined non-hormonal contraceptive methods that result in a failure rate of <1% per year during the treatment period and for up to 3 months after the last dose of study drug
- •- For men: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating sperm during the treatment period and for at least 8 weeks after the last dose of study drug
- •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 140
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 70
排除标准
- •- Pregnant or lactating, or intending to become pregnant during the study
- •- Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 12 months following randomization
- •- Skin thickening (scleroderma) limited to the face or areas distal to the elbows or knees at screening
- •- Rheumatic autoimmune disease other than SSc, including but not limited to rheumatoid arthritis (RA) (diagnosed using ACR/EULAR criteria), systemic lupus erythematosus, mixed connective tissue disorder, polymyositis, dermatomyositis, eosinophilic fasciitis, primary Sjögren's syndrome, and eosinophilic myalgia syndrome, as determined by the investigator
- •- History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
- •- Evidence of moderately severe concurrent nervous system, renal, endocrine, or gastrointestinal (GI) disease not related to SSc, as determined by the investigator
- •Pulmonary disease with FVC <=55% of predicted (best of three measurements) or diffusion capacity of the lung for carbon monoxide [DLCO] (hemoglobin corrected) <=45% of predicted (best of three measurements)
- •- Class II or higher pulmonary arterial hypertension (PAH), as defined by the World Health Organization
- •- Evidence of other moderately severe pulmonary disease (e.g., asthma, emphysema), as determined by the investigator
- •- Cardiovascular disease with significant arrhythmia, congestive heart failure (New York Heart Association Class II-IV), unstable angina, uncontrolled hypertension, cor pulmonale, or symptomatic pericardial effusion
- •- History of myocardial infarction in the last 6 months prior to screening
- •- Current liver disease, as determined by the investigator
- •- History of diverticulitis or chronic ulcerative lower GI disease, such as Crohn disease, ulcerative colitis, or other symptomatic lower GI conditions that might predispose a patient to perforations
- •- Known active current or significant history of recurrent bacterial, viral, fungal, mycobacterial, or other infections, including but not limited to atypical mycobacterial disease, hepatitis B or C, herpes zoster, infected digital ulcers, and osteomyelitis
- •- Any major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 4 weeks prior to screening or oral antibiotics within 2 weeks prior to screening
- •- Significant history of recurrent tuberculosis (TB), active TB requiring treatment within the previous 3 years, or untreated latent TB, Patients should be screened for latent TB, and, if positive, will be eligible for the study after treatment per local standard practices
- •- History of or currently active primary or secondary immunodeficiency
- •- Evidence of malignant disease, or malignancies diagnosed within the previous 5 years (with the exception of local basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix uteri that has been excised and cured)
- •- Neuropathies or other conditions that might interfere with pain evaluation, as determined by the investigator
研究者
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