CTRI/2023/01/049000进行中（未招募）3 期
A Randomized, Double Blind, Multicenter, Parallel Group Study to Compare Efficacy, Safety, Immunogenicity, Pharmacokinetics and Pharmacodynamics of BP08 (Tocilizumab) and RoActemra® in patients with moderate to severe Rheumatoid Arthritis (RA) with inadequate response to Methotrexate
CuraTeQ Biologics Private Ltd.20 个研究点 分布在 1 个国家目标入组 204 人开始时间: 2023年1月2日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 204
- 试验地点
- 20
- 主要终点
- Proportion of patients with ACR 20 response (≥20% improvement in the ACR core criteria)
研究概览
简要总结
Rheumatoid arthritis is a chronic, serious progressive and debilitating inflammatory disease characterized by joint swelling, joint tenderness, and destruction of synovial joints, leading to severe disability and premature mortality. RA is considered as an auto immune disease. The etiology of RA is thought to be multifactorial and is not fully understood; however, pro-inflammatory cytokines (tumour necrosis factor [TNF]-α, interleukin [IL]-6, IL-1β) are known to play a role in the disease pathogenesis in RA by propagating inflammation and leading to joint destruction.
This is a Phase I/III, Multicentric, Comparative, Randomized, Double blind, Active Controlled, Parallel group clinical study to evaluate and compare the efficacy, pharmacokinetics, pharmacodynamics, immunogenicity and safety of intravenous injection of BP08 (Tocilizumab) mfg. by CuraTeQ Biologics Private Limited with reference medicinal product RoActmera® (Tocilizumab of Hoffman La Roche) injection in patients with rheumatoid arthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult male or female patients of age 18 to 65 years (both inclusive) Patients who are able to comply with study and follow-up procedures and provide written informed consent Patients with diagnosis of Active Rheumatoid Arthritis as per the 2010 American College of Rheumatology/European League Against Rheumatism classification criteria for RA score of ≥6 and has a disease duration of at least three months before randomization Patients with Swollen Joint Count (SJC) ≥6 (66 joint count), and Tender Joint Count (TJC) ≥6 (68 joint count) at screening and randomization Patients who are on NSAIDs, must be on a stable dose for at least 4 weeks prior to randomization.
- •Patient willing to receive oral folic acid (at least 5 mg/week or as per local practice) or folic acid (at least 1 mg/day or as per local practice) or equivalent during the trial period.
- •Men and women of childbearing potential must agree to use adequate birth control measures and continue such precautions for 6 months after receiving the last injection.
排除标准
- •Patients with known or suspected allergy or hypersensitivity to Tocilizumab or formulation excipients Patients with functional class IV disease as defined by the American College of Rheumatology (ACR) classification of functional status in RA Patients with prior or current use of Tocilizumab Patients with autoimmune disease other than Rheumatoid Arthritis like psoriatic arthritis (PsA), ankylosing spondylitis (AS), Crohn’s disease (CD), ulcerative colitis(UC) and plaque psoriasis.
- •Patients with active systemic bacterial, viral, fungal, mycobacterial, or other infections or on systemic antibiotics Patients with known history of active tuberculosis and tests positive in QuantiFERON®-TB Gold In-Tube (QFT-G) and Mantoux test at screening Patients with previous history of intestinal ulceration or diverticulitis.
- •Patient with history of and/or current medical condition, classed as clinically significant by the investigator, including cardiac, gastrointestinal, renal, hepatic, hematological (including pancytopenia, aplastic anemia or blood dyscrasia), metabolic (including known diabetes mellitus), neurologic or pulmonary diseases, or psychiatric condition.
- •Patients with history of any form of cancer within the 10 years except skin cancer and cervical cancer in-situ Patients with uncontrolled diabetes or hypertension Patients with history of New York Heart Association class III/IV congestive heart failure, unstable angina, cardiac arrythmias, or myocardial infarction within 6 months prior to randomization Patients with history or signs of lymphoproliferative disease Patients with significant systemic manifestations of rheumatoid arthritis such as vasculitis, interstitial lung disease, Pleuritis, pericarditis, Scleritis, Sjogren syndrome, Feltys syndrome and Lymphoma Patients must not be on prescription herbal, homeopathic or ayurvedic medicines including massage/manipulation therapies for at least one month prior to randomization.
- •Patients with history of major surgery (including joint surgery) within 12 weeks prior to randomization Patients with history of alcohol or drug abuse within 6 months prior to randomization Patients with pregnancy or lactation at the time of screening Patients with HIV infection, chronic hepatitis B, or hepatitis C infection Patients with SARS CoV2 RT-PCR test positive at the time of screening Patients with history of blood donation or blood loss of >300ml within 3 months prior to randomization Patients with any medical, psychological, or social condition that may interfere with the patients participation in the study or evaluation of the study results.
结局指标
主要结局
Proportion of patients with ACR 20 response (≥20% improvement in the ACR core criteria)
时间窗: 12 weeks
次要结局
- Proportion of patients with an ACR 50 and ACR 70 response (≥50%, ≥70% improvement in the ACR core criteria)(8 weeks, 12 weeks and 24 weeks)
- Proportion of patients with ACR 20 response (≥20% improvement in the ACR core criteria)(8 weeks and 12 weeks)
- Change from baseline in Disease Activity Score 28 (DAS28-ESR)
- Change from baseline in Disease Activity Score 28 (DAS28-CRP)(8 weeks, 12 weeks, and 24 weeks)
- Change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)(8 weeks, 12 weeks, and 24 weeks)
- Compare pharmacokinetic parameters(As per pre-specified timepoints in the protocol)
- Treatment Emergent Adverse Events (TEAEs) evaluated on the basis of changes in(clinical signs and symptoms and changes in safety laboratory values)
- Incidence and Titres of Anti-Tocilizumab Antibodies between both groups(As per pre-specified timepoints in the protocol)
研究者
研究点 (20)
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