NCT01258712已完成3 期
Randomized, Placebo-controlled Study of Tocilizumab in Combination With Methotrexate for Treatment of Moderate to Severe Rheumatoid Arthritis Patients
Chugai Pharma Taiwan12 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2010年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 12
- 主要终点
- Proportion of patients with an American College of Rheumatology 20(ACR20) response
研究概览
简要总结
This is a Phase III study to evaluate efficacy and safety of Tocilizumab in patients with Rheumatoid Arthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with history of moderate-to- severe rheumatoid arthritis for more than 6 months according to the American College of Rheumatology (ACR) 1987 revised criteria for the classification of RA.
- •Patients who failed to achieve clinical response to treatment of at least 2 DMARDs(disease modifying anti-rheumatic drug) (including MTX) for at least 12 weeks within 12 months prior to screening, of which MTX must have been at a stable dose of 10-20 mg/wk for at least 12 weeks prior to screening. All other DMARDs should be given at standard therapeutic dose.
- •Patients who satisfy swollen joint count (SJC) ≥ 6 (66 joint count) and tender joint count (TJC) ≥ 8 (68 joint count) at screening and baseline.
- •C-reactive protein (CRP) level ≥ 1 mg/dl or an erythrocyte sedimentation rate (ESR) ≥ 28 mm/hour at screening and at baseline.
排除标准
- •Patients who have received a major surgery including joint surgery 8 weeks prior to the screening or are scheduled to be operated within 6 months after the enrolment.
- •Patients with rheumatoid autoimmune disease other than RA, including but not limited to SLE(system lupus erythematosus), or significant systemic involvement secondary to RA.
- •Patients who belong to the Class IV of the ACR classification criteria for functional status of RA. (ACR Amended Criteria for the Classification of Functional Capacity in Rheumatoid Arthritis; Class IV: Largely or wholly incapacitated with patient bedridden or confined to wheel chair, permitting little or no self-care).
- •Patients with a history of hypersensitivity to human, humanized or murine monoclonal antibodies or patients with contraindication for them.
- •Patients who currently have or have a history of recurrence of bacterial, viral,fungal, or mycobacterial infections or other infectious diseases; tuberculosis(TB),atypical mycobacterial disease, clinically significant granulomatous disease on chest radiograph, hepatitis B, hepatitis C, or herpes zoster and etc. However, a patient with hand & foot fungal infections can participate.
研究组 & 干预措施
1
Experimental
干预措施: Tocilizumab + methotrexate(MTX) (Drug)
2
Placebo Comparator
干预措施: Tocilizumab placebo + methotrexate(MTX) (Drug)
结局指标
主要结局
Proportion of patients with an American College of Rheumatology 20(ACR20) response
时间窗: at baseline and week 24
次要结局
- Proportion of patients with ACR50 response(at baseline and week 24)
- Proportion of patients with ACR70 response(at baseline and week 24)
- Mean change from baseline of Swollen joint count(SJC) and Tender joint count(TJC) respectively(at baseline and week 24)
- Mean change from baseline in disease activity using 28-joint modified disease activity score (DAS28)(at baseline and week 24)
- Proportion of patients achieving DAS28 remission (DAS28 < 2.6)(at week 24)
- Adverse event incidence(from baseline to week 24)
- Mean change from baseline to evaluation visits in vital signs(from baseline to week 24)
- Result of Electrocardiogram. From baseline to evaluation visits(from baseline to week 24)
- Mean change from baseline visit to evaluation visits in quantitative hematological exam results (including Hb, Ht, RBC, WBC & differential, platelet counts).(from baseline to week 24)
- Mean change from baseline visit to evaluation visits in quantitative Biochemical exam of blood results (including AST, ALT, Alk-p, γ-GTP, LDH, total protein, albumin, total bilirubin, BUN, uric acid, creatinine, glucose, ferritin, K, Na, Cl, Ca, P.).(from baseline to week 24)
- Mean change from baseline visit to evaluation visits in quantitative serum lipid exam results.(from baseline to week 24)
- Mean change from baseline visit to evaluation visits in quantitative urinalysis results.(from baseline to week 24)
研究者
研究点 (12)
Loading locations...
相似试验
已完成
3 期
A Study of the Efficacy and Safety of Tocilizumab in Participants With Systemic Sclerosis (SSc)Systemic SclerosisNCT02453256Hoffmann-La Roche212
已完成
3 期
A Study of Subcutaneous (SC) Tocilizumab (RoActemra/Actemra) in Participants With Active Rheumatoid Arthritis (RA) and Inadequate Response to Disease-Modifying Anti-Rheumatic Drugs (DMARDs)Rheumatoid ArthritisNCT02046616Hoffmann-La Roche133
已完成
3 期
A Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Severe COVID-19 PneumoniaCOVID-19 PneumoniaNCT04320615Hoffmann-La Roche452
已完成
3 期
Tocilizumab Treatment in Graves´ Ophthalmopathy (Graves´ Orbitopathy or Thyroid Eye Disease)Thyroid Associated OphthalmopathiesGraves´ OphthalmopathyThyroid Eye DiseaseNCT01297699Hospital Clinico Universitario de Santiago32
撤回
3 期
A Study to Evaluate the Efficacy and Safety of Itolizumab in Subjects Hospitalized With COVID-19CoronavirusNCT04605926Biocon Limited