NCT00977106已完成3 期
Comparative Double Blind Placebo Controlled Clinical Study on Tocilizumab Rapid Efficacy on Patients Relief in rheumatoïd Arthritis With an Inadequate Response to DMARDs or Anti TNF :TORPEDO
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 103
- 主要终点
- Percentage of Participants With Clinically Significant Improvement in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 4
研究概览
简要总结
This study will assess the onset and maintenance of effect of tocilizumab on relief in patients with active moderate or severe rheumatoid arthritis who have had an inadequate response to DMARDs or anti-TNF. For the first, double-blind, part of the study patients will be randomized to receive an iv infusion of either 8mg/kg tocilizumab or placebo. After 4 weeks this will be followed by 11 months treatment with tocilizumab 8mg/kg iv infusion every 4 weeks. Methotrexate or DMARD therapy will be continued throughout study treatment. Target sample size is >100.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients >/= 18 years of age
- •active moderate or severe rheumatoid arthritis of <10 years duration with inadequate response to methotrexate or anti-TNF
- •on methotrexate treatment for at least 10 weeks, at least 8 weeks on stable dose
- •patients receiving oral corticosteroids and/or NSAIDs should be at stable dose for 4 weeks
排除标准
- •rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA
- •functional class IV by ACR classification
- •history of inflammatory joint disease other than RA
- •previous treatment with cell-depleting therapies, abatacept or rituximab
- •active current or history of recurrent infection, or any major episode of infection requiring hospitalization or treatment with iv antibiotics <4 weeks or oral antibiotics <2 weeks prior to screening
研究组 & 干预措施
3
Experimental
干预措施: tocilizumab [RoActemra/Actemra] (Drug)
1
Experimental
干预措施: tocilizumab [RoActemra/Actemra] (Drug)
2
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Percentage of Participants With Clinically Significant Improvement in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 4
时间窗: Week 4
HAQ-DI includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0 (equals)=without difficulties; 1= with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3. Relevant clinical improvement was defined as a reduction of at least 0.22 points in HAQ-DI.
次要结局
- Swollen Joint Count (SJC) Based on 28-Joint Count During the Open Treatment Period(Baseline and Weeks 12, 24, 36, and 48)
- SJC Based on 40-Joint Count During the Double-Blind Treatment Period(Baseline and Weeks 1 and 4)
- Percent Change From Baseline in SJC Based on 40-Joint Count During the Double-Blind Treatment Period(Weeks 1 and 4)
- SJC Based on 40-Joint Count During the Open Treatment Period(Baseline and Weeks 12, 24, 36, and 48)
- Disease Activity Score Based on 28-Joints Count (DAS28) During the Double-Blind Treatment Period(Baseline and Weeks 1 and 4)
- Disease Activity Score Based on 40-Joints Count (DAS40) During the Double-Blind Treatment Period(Baseline and Weeks 1 and 4)
- DAS40 During the Open Treatment Period(Baseline and Weeks 12, 24, 36, and 48)
- DAS28 During the Open Treatment Period(Baseline and Weeks 12, 24, 36, and 48)
- Patient Global Assessment of Disease Activity During the Double-Blind Treatment Period(Baseline, Weeks 1 and 4)
- Patient Global Assessment of Disease Activity During the Open Treatment Period(Baseline, Weeks 12, 24, 36 and 48)
- Physician Global Assessment of Disease Activity During the Double-Blind Treatment Period(Baseline and Week 4)
- Physician Global Assessment of Disease Activity During the Open Treatment Period(Baseline, Weeks 12, 24, 36, and 48)
- Patient Global Assessment of Pain During the Double-Blind Treatment Period(Baseline and Week 4)
- Patient Global Assessment of Pain During the Open Treatment Period(Baseline and Weeks 12, 24, 36, and 48)
- Synovitis Score During the Double-Blind Treatment Period Assessed Using B-Mode Ultrasound(Baseline, Weeks 1 and 4)
- Synovitis Score During the Double-Blind Treatment Period Assessed Using Power Doppler Ultrasound(Baseline, Weeks 1 and 4)
- Percent Change From Baseline in Synovitis Score During the Open Treatment Period Assessed Using B-Mode Ultrasound(Weeks 12, 24, and 48)
- Percent Change From Baseline in Synovitis Score During the Open Treatment Period Assessed Using Power Doppler Ultrasound(Weeks 12, 24, and 48)
- Erythrocyte Sedimentation Rate During the Double-Blind Treatment Period(Baseline, Weeks 1 and 4)
- Percent Change From Baseline in Erythrocyte Sedimentation Rate During the Double-Blind Treatment(Weeks 1 and 4)
- Erythrocyte Sedimentation Rate During the Open Treatment Period(Baseline, Weeks 12, 24, 36, and 48)
- C-Reactive Protein During the Double-Blind Treatment Period(Baseline, Weeks 1 and 4)
- Percent Change From Baseline in C-Reactive Protein During the Double-Blind Treatment Period(Weeks 1 and 4)
- C- Reactive Protein During the Open Treatment Period(Baseline, Weeks 12, 24, 36, and 48)
- Serum Amyloid A Component During the Double-Blind Treatment Period(Baseline, Weeks 1 and 4)
- Percent Change From Baseline in Serum Amyloid A Component During the Double-Blind Treatment Period(Weeks 1 and 4)
- Serum Amyloid A Component During the Open Treatment Period(Baseline, Weeks 12, 24, 36, and 48)
- Beta 2 Microglobulin Levels During the Open Treatment Period(Baseline, Weeks 12, 24, 36, and 48)
- Beta 2 Microglobulin Levels During the Double-Blind Treatment Period(Baseline, Weeks 1 and 4)
- Percent Change From Baseline in Beta 2 Microglobulin Levels During the Double-Blind Treatment Period(Weeks 1 and 4)
- Bone Mineral Density(Baseline and Week 48)
- Percentage of Participants Treated With Corticosteroids Over the 1-Year Tocilizumab Period(Baseline, Weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48)
- S-Sclerostin and P-Dkk1 (Wnt Signaling Inhibitor Dickkopf) Over the 1-Year Tocilizumab Period(Baseline, Weeks 12, 24, and 48)
- Serum Procollagen Type II N-Propeptide (s-PIINP), Serum Procollagen Type I N Propeptide (s-PINP), and Serum Carboxy-Terminal Collagen Crosslinks-1 (s-CTX-I) Over the 1-Year Tocilizumab Period(Baseline and Weeks 12, 24, and 48)
- Serum Osteogenic Growth Peptide (s-OGP) Over the 1-Year Tocilizumab Period(Baseline and Weeks 12 and 48)
- Weekly Methotrexate (MTX) Dose(Baseline and Weeks 24 and 48)
- HAQ-DI During the Double-Blind Treatment Period(Screening and Week 4)
- HAQ-DI During the Open Treatment Period(Baseline and Weeks 12, 24, 36, and 48)
- Functional Assessment of Chronic Illness in Therapy - Fatigue (FACIT-F) During the Double-Blind Treatment Period(Day 0, Week 1, and Week 4)
- Percent Change From Baseline in FACIT-F During the Double-Blind Treatment Period(Week 1 and Week 4)
- Tender Joint Count (TJC) Based on 28-Joint Count During the Double-Blind Treatment Period(Baseline and Weeks 1 and 4)
- Percent Change From Baseline in TJC Based on 28-Joint Count During the Double-Blind Treatment Period(Weeks 1 and 4)
- TJC Based on 28-Joint Count During the Open Treatment Period(Baseline and Weeks 12, 24, 36, and 48)
- TJC Based on 40-Joint Count During the Double-Blind Treatment Period(Baseline and Weeks 1 and 4)
- Percent Change From Baseline in TJC Based on 40-Joint Count During the Double-Blind Treatment Period(Weeks 1 and 4)
- FACIT-F During the Open Treatment Period(Baseline, Weeks 12, 24, 36, and 48)
- Hemoglobin Concentration During the Double-Blind Treatment Period(Baseline and Weeks 1 and 4)
- Hemoglobin Concentration During the Open Treatment Period(Baseline, Weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48)
- TJC Based on 40-Joint Count During the Open Treatment Period(Baseline and Weeks 12, 24, 36, and 48)
- Swollen Joint Count (SJC) Based on 28-Joint Count During the Double-Blind Treatment Period(Baseline and Weeks 1 and 4)
- Percent Change From Baseline in SJC Based on 28-Joint Count During the Double-Blind Treatment Period(Weeks 1 and 4)
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