NCT01951170已完成3 期
An Open-Label Study to Evaluate Non-Progression Of Structural Joint Damage Of Subcutaneous Tocilizumab In Patients With Moderate To Severe Active Rheumatoid Arthritis (Ac-Cute)
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
- 52
- 主要终点
- Change From Baseline in Genant-modified Total Sharp Score (mTSS)
研究概览
简要总结
This open-label, single-arm study will evaluate the efficacy and safety of tocilizumab in patients with active moderate to severe rheumatoid arthritis. Participants will receive a subcutaneous dose of tocilizumab 162 mg once weekly. The anticipated time on study treatment is 24 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 at least 18 years of age
- •Patients with a diagnosis of active moderate to severe rheumatoid arthritis (RA)
- •Oral corticosteroids and nonsteroidal anti-inflammatory are permitted if on a stable dose regimen for >/= 4 weeks prior baseline
- •Permitted non-biologic disease-modifying anti-rheumatic drugs (DMARDs) used alone or in combination are allowed if at a stable dose for at least 4 weeks prior to baseline
- •Receiving treatment on an outpatient basis, not including tocilizumab
- •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 for at least 5 months following the last dose tocilizumab
- •Previous or current treatment with methotrexate with an inadequate response to methotrexate, intolerance to methotrexate or treatment with methotrexate was considered as inappropriate
- •Evidence of one or more erosions in hands or feet assessed by X-ray attributable to RA or magnetic resonance imaging (MRI) of wrist of metacarpophalangeal (MCP) joints of dominant hand
排除标准
- •Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following baseline
- •Rheumatic autoimmune disease other than rheumatoid arthritis
- •Functional Class IV as defined by the American College of Rheumatology (ACR) Classification of Functional Status in Rheumatoid Arthritis
- •Diagnosis of juvenile idiopathic arthritis or juvenile RA and/or RA before the age of 16
- •Prior history of current inflammatory joint disease other than RA
- •Exposure to tocilizumab at any time prior to baseline
- •Treatment with any investigational agent within 4 weeks (or five half-lives of the investigational drug, whichever is longer) of screening
- •Previous treatment with any cell-depleting therapies
- •Treatment with intravenous (IV) gamma globulin, plasmapheresis within 6 months of baseline
- •Intraarticular (IA) or parenteral corticosteroids within 4 weeks prior to baseline
- •Any previous treatment with alkylating agents such as chlorambucil, or with total lymphoid irradiation
- •Treatment with 2 or more anti-tumor necrosis factor (TNF) agents or any other biologic agent at any time prior to screening
- •Evidence of serious uncontrolled concomitant disease (e.g., cardiovascular, nervous system, pulmonary)
- •History of diverticulitis, diverticulosis requiring antibiotic treatment, or chromic ulcerative lower gastrointestinal (GI) disease such as Crohn's disease, ulcerative colitis, or other symptomatic lower genitourinary (GU) conditions that might predispose to perforation
- •Known active current or history of recurrent infections
研究组 & 干预措施
Tocilizumab
Experimental
Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.
干预措施: Tocilizumab (Drug)
结局指标
主要结局
Change From Baseline in Genant-modified Total Sharp Score (mTSS)
时间窗: From baseline to Week 24
The mTSS is a measure of joint damage that combines scores for bone erosion and joint-space narrowing (JNS). Erosion score: A total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=normal to 3.5=very severe erosion. JNS score: A total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=normal to 4.0=definite ankylosis (stiffness or fixation of a joint). mTSS scores ranged from 0 (normal) to 292 (worst possible total score). Change from baseline = mTSS score at Week 24 minus score at baseline. An increase in mTSS from baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.
次要结局
- Change From Baseline in Patient's Global Assessment of Disease Activity Visual Analog Scale (PGA VAS)(From baseline to Week 24)
- Change From Baseline in Swollen Joint Count (SJC)(From baseline to Week 24)
- Change From Baseline in Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Scoring of Bone Erosions(From baseline to Week 24)
- Percentage of Participants With Positive American College of Rheumatology 20/50/70 (ACR20/50/70) Responses(From baseline to Week 24)
- Percentage of Participants With European League Against Rheumatism (EULAR) Response(From baseline to Week 24)
- Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)(From baseline to Week 24)
- Percentage of Participants With Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) Remission(At Week 24)
- Change From Baseline in Patient's Global Assessment of Pain Using a Visual Analog Scale (PGA Pain VAS)(From baseline to Week 24)
- Change From Baseline in Physician Global Assessment of Disease Activity(From baseline to Week 24)
- Change From Baseline in Simplified Disease Activity Index (SDAI)(From baseline to Week 24)
- Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)(From baseline to Week 24)
- Change From Baseline in Clinical Disease Activity Index (CDAI)(From baseline to Week 24)
- Change From Baseline in Total Tender Joint Count (TJC)(From baseline to Week 24)
- Change From Baseline in RAMRIS Scoring of Osteitis(From baseline to Week 24)
- Safety: Number of AEs Leading to Tocilizumab Dose Modification or Study Treatment Withdrawal(Up to Week 32 (end of follow up: 8 weeks after end of treatment))
- Change From Baseline in RAMRIS Scoring of Cartilage Loss(From baseline to Week 24)
- Change From Baseline in RAMRIS Scoring of Synovitis(From baseline to Week 24)
- Safety: Percentage of Participants With Adverse Events (AEs)(Up to Week 32 (end of follow up: 8 weeks after end of treatment))
- Safety: Number of Participants With Confirmed Positive Assessment of Tocilizumab Immunogenicity(At baseline, Week 32 (end of follow up: 8 weeks after end of treatment))
研究者
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