NCT01987479已完成3 期
Multi-Center, Open Label, Single Arm Phase IIIB Study on Safety and Efficacy of Subcutaneous Tocilizumab in Monotherapy or in Combination With Methotrexate or Other Non-Biologic Disease Modifying Antirheumatic Drugs in Rheumatoid Arthritis Patients With an Inadequate Response to Non-Biologic DMARDs - OSCAR
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
- 150
- 试验地点
- 20
- 主要终点
- Percentage of Participants With Adverse Events
研究概览
简要总结
This multi-center, open-label single arm Phase IIIb study will evaluate the safety and efficacy of subcutaneous (SC) tocilizumab administered as monotherapy and/or in combination with methotrexate or other non-biologic disease modifying antirheumatic drugs (DMARDs) in participants with rheumatoid arthritis (RA) with an inadequate response to non-biologic DMARDs.
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
- •Participants with a diagnosis of active RA according to the revised (1987) ACR criteria or EULAR/ACR (2010) criteria.
- •Oral corticosteroids (≤10 mg/day prednisone or equivalent), nonsteroidal anti-inflammatory drugs (NSAIDs) and non-biologic DMARDs are permitted if on a stable dose regimen for greater than or equal to (≥]) 4 weeks prior to Baseline.
- •Use of effective contraception throughout the study as defined by protocol; female participants of childbearing potential cannot be pregnant.
排除标准
- •Presence of clinically significant medical conditions.
- •History of diverticulitis, diverticulosis requiring antibiotic treatment, or chronic ulcerative lower gastrointestinal disease that might predispose to perforation.
- •Current or history of recurrent bacterial, viral, fungal, mycobacterial, or other infections.
- •Any infection requiring hospitalization or treatment with intravenous antibiotics within 4 weeks of Screening or oral antibiotics within 2 weeks of Screening.
- •Clinically significant findings on laboratory tests.
- •Positive hepatitis B surface antigen or hepatitis C antibody.
- •Active tuberculosis requiring treatment within the previous 3 years.
- •Evidence of active malignant disease, malignancies diagnosed within the previous 10 years, or breast cancer diagnosed within the previous 20 years.
- •History of alcohol, drug, or chemical abuse within 1 year prior to Screening.
- •Neuropathies or other conditions that might interfere with pain evaluation.
- •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 RA, including systemic lupus erythematosis, mixed connective tissue disorder, scleroderma, polymyositis, or significant systemic involvement secondary to RA (e.g., vasculitis, pulmonary fibrosis or Felty's syndrome). Secondary Sjögren's syndrome with RA is permitted.
- •Functional Class IV as defined by the ACR Classification of Functional Status in RA.
- •Diagnosis of juvenile idiopathic arthritis or juvenile RA, and/or RA before the age of 16 years.
- •Prior history of or current inflammatory joint disease other than RA.
- •Exposure to tocilizumab (either intravenous or SC) 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, including investigational agents or approved therapies, with alkylating agents such as chlorambucil, or with total lymphoid irradiation.
- •Treatment with IV gamma globulin, plasmapheresis within 6 months of Baseline.
- •Immunization with a live/attenuated vaccine within 4 weeks prior to Baseline.
研究组 & 干预措施
Tocilizumab Alone or in Combination with Methotrexate or DMARD
Experimental
Participants will receive a weekly SC injection of tocilizumab 162 milligrams (mg) as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
干预措施: Non-Biologic DMARDs (Drug)
Tocilizumab Alone or in Combination with Methotrexate or DMARD
Experimental
Participants will receive a weekly SC injection of tocilizumab 162 milligrams (mg) as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
干预措施: Tocilizumab (Drug)
Tocilizumab Alone or in Combination with Methotrexate or DMARD
Experimental
Participants will receive a weekly SC injection of tocilizumab 162 milligrams (mg) as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
干预措施: Methotrexate (Drug)
结局指标
主要结局
Percentage of Participants With Adverse Events
时间窗: Baseline up to Week 32
An adverse event was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Adverse events included serious as well as non-serious adverse events.
次要结局
- Change From Baseline in Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) Score at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal(Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24))
- Percentage of Participants Achieving an American College of Rheumatology Criteria 20 (ACR20) Response(Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24))
- Percentage of Participants Achieving an ACR50 Response(Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24))
- Percentage of Participants Achieving an ACR70 Response(Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24))
- Percentage of Participants Achieving an ACR90 Response(Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24))
- Percentage of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR(Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24))
- Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal(Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24))
- Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, 16, 20, 24, and Early Withdrawal(Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24))
- Change From Baseline in Total TJC at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal(Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24))
- Change From Baseline in Total SJC at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal(Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24))
- Percentage of Participants With Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Dose Reductions or Discontinuation Categorized by Reasons(From Week 16 and before Week 20; From Week 20 and before Week 24)
- Percentage of Participants With Corticosteroid Dose Reductions or Discontinuation Categorized by Reasons(From Week 16 and before Week 20; From Week 20 and before Week 24)
- Time to Discontinuation or First Dose Reduction of Corticosteroids or NSAIDs(Baseline up to Week 32)
- Percentage of Participants With Anti-Tocilizumab Antibodies(Baseline, Weeks 12 and 24, early withdrawal (up to Week 24), follow-up visit (8 weeks after last dose of tocilizumab, up to 32 weeks))
- Serum Levels of Tocilizumab(Baseline, Weeks 12 and 24, Early Withdrawal (up to Week 24), Follow-up Visit (8 weeks after last dose of tocilizumab, up to 32 weeks))
- Serum Levels of Soluble Interleukin-6 Receptors (sIL-6Rs)(Baseline, Weeks 12 and 24, Early Withdrawal (up to Week 24), Follow-up Visit (8 weeks after last dose of tocilizumab, up to 32 weeks))
- Patient Global Assessment of Disease Activity VAS Scores(Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and Early withdrawal (up to Week 24))
- Patient Pain VAS Scores(Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and Early withdrawal (up to Week 24))
- Health Assessment Questionnaire-Disability Index (HAQ-DI) Score(Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and early withdrawal (up to Week 24))
- Percentage of Participants Compliant to Tocilizumab Treatment as Measured by Diary Cards and Return Records(Weeks 2, 4, 8, 12, 16, 20, 24, and early withdrawal (up to Week 24))
- Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score(Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and early withdrawal (up to Week 24))
研究者
研究点 (20)
Loading locations...
相似试验
已完成
3 期
A Study of Subcutaneous Tocilizumab as Monotherapy and/or in Combination With Non-Biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs) in Participants With Rheumatoid ArthritisRheumatoid ArthritisNCT01941095Hoffmann-La Roche100
已完成
3 期
A Phase 3b, Open-label, Multi-center Study on Durvalumab in Combination With Gemcitabine-based Chemotherapy as 1L Treatment for the Chinese Patients With Unresectable Biliary Tract Cancers (BTC)Biliary Tract CancersNCT05924880AstraZeneca116
已完成
3 期
Pasireotide in Patients With Acromegaly Inadequately Controlled With First Generation Somatostatin AnaloguesAcromegalyNCT02354508Novartis Pharmaceuticals123
已完成
3 期
4EVER - Efficacy, Safety, Health Economics, Translational Research of Postmenopausal Women With Estrogen Receptor Positive Locally Advanced or Metastatic Breast CancerMetastatic Breast CancerNCT01626222Novartis Pharmaceuticals301
已完成
3 期
To Study Clinical Effectiveness and Safety of Olaparib Monotherapy in Metastatic Breast Cancer Patients.HER2-ve Metastatic Breast CancerGermline BRCA1/2 MutationsSomatic BRCA1/2 MutationsNCT03286842AstraZeneca256