CTRI/2016/04/006884已完成3 期
A Prospective, Randomized, Multiple-Dose, Multi-Center, Comparative,Parallel group Clinical Study to Evaluate the Efficacy, Safety, Immunogenicity, and Pharmacokinetics of Subcutaneous Injection of Adalimumab (Test Product, Hetero) and Reference Medicinal Product (Reference product, AbbVie) Concomitantly Administered with Methotrexate in Patients with Rheumatoid Arthritis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 19
- 主要终点
- • Proportion of patients with ACR 20 response (≥20% improvement in the ACR core criteria) at end of 12 weeks study treatments
研究概览
简要总结
This study is an investigator blinded, randomized, active controlled, parallel group clinical study to evaluate the efficacy and safety of subcutaneous injection of Hetero-Adalimumab with Reference medicinal product (Adalimumab, AbbVie Inc.) in patients with Rheumatoid arthritis. Appropriate number of patients will be enrolled and randomly assigned into two treatment groups in the ratio (2:1): Hetero-Adalimumab vs Reference product (Adalimumab, AbbVie Inc.). Primary objective is to compare the efficacy of Hetero-Adalimumab with Reference medicinal product (Adalimumab, AbbVie Inc.) in patients with Rheumatoid arthritis. Secondary objectives are to compare the safety, pharmacokinetic, pharmacodynamics and immunogenic potential of Hetero-Adalimumab with Reference medicinal product (Adalimumab, AbbVie Inc.)
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Investigator 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
- •â€¢ Ability to comply with study and follow-up procedures and provide written informed consent • 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 baseline • Swollen Joint Count (SJC) ≥6 (66 joint count), and Tender Joint Count (TJC) ≥6 (68 joint count) at screening and baseline • Erythrocyte sedimentation rate of more than 28mm/hr measured by westergreen method and C-reactive protein more than 6mg/L • Subjects must have been on treatment with methotrexate (10 to 25 mg/week) (oral or injectable) for at least 3 months and stable dose between 10 and 25 mg/week for at least 4 weeks prior to screening.
- •Subjects who are on oral treatment will continue to have oral dose and those who are on injectable treatment will continue to have injectable dose.
- •â€¢ Subjects using oral corticosteroids must have been on a stable dose of up to 10 mg/day prednisolone or equivalent, for at least 4 weeks prior to screening.
- •If currently not using corticosteroids, the subjects must have not received corticosteroids for at least 4 weeks prior to screening.
- •Prior escalation of doses of steroids will not be allowed.
- •â€¢ If subjects using NSAIDs, they should have been on a stable dose for at least 4 weeks prior to screening • The screening laboratory tests must be: o Haemoglobin ≥8.0 g/dL o Neutrophils ≥1.5 × 109/L o Platelets ≥100 × 109/L o SGOT and SGPT ≤2 × ULN o Alkaline phosphatase levels ≤2 × ULN o Serum creatinine ≤1.7 mg/dL • Men and women of childbearing potential must be using adequate birth control measures, as discussed with the study doctor and should agree to continue such precautions for 6 months after receiving the last injection.
排除标准
- •â€¢ Drug allergy, hypersensitivity or intolerance: Known or suspected allergy or hypersensitivity to Adalimumab or excipients • Functional Class IV as defined by the American College of Rheumatology (ACR) classification of functional status in RA • History of use of disease-modifying anti-rheumatic drugs (DMARDs) other than methotrexate within 4 weeks prior to randomization (8 weeks prior for leflunomide) • Prior use of any anti-CD4 therapy or TNFα antagonists (eg, infliximab, etanercept, certolizumab pegol or golimumab, tocilizumab, rituximab) including adalimumab.
- •â€¢ Subjects with prior and current use of anakinra (IL-1 receptor antagonist) or abatacept.
- •â€¢ Use of intra-articular or parenteral corticosteroids within 4 weeks prior to screening visit.
- •Inhaled corticosteroids for stable medical conditions are allowed.
- •â€¢ Subjects with autoimmune disease other than Rheumatoid Arthritis (psoriatic arthritis (PsA), ankylosing spondylitis (AS), Crohn’s disease (CD), ulcerative colitis (UC) and psoriasis (all types).
- •â€¢ Active systemic bacterial, viral, fungal, mycobacterial, or other infections • Subject with known history or family history of active tuberculosis and/ or tests positive in QuantiFERON®-TB Gold In-Tube (QFT-G) • History of treatment with intravenous antibiotics within 30 days or oral antibiotics within 14 days prior to screening • Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic or cerebral disease • History or presence of any form of cancer within the 10 years prior to screening except skin cancer and cervical cancer in-situ • Patients with uncontrolled diabetes or hypertension.
- •â€¢ History of congestive heart failure (New York Heart Association class III/IV) or unstable angina • Current, recent (within 4 weeks prior to screening) or planned participation in an investigational drug study • History of alcohol or drug abuse within 6 months prior to screening • Pregnancy or lactation and positive pregnancy test (above clinical significant limits) in non-menopausal women • Patients with history or evidence of HIV infection, chronic hepatitis B, or hepatitis C infection • Blood donation or blood loss of >300ml in the last 3 months • Any medical, psychological, or social condition that may interfere with the subjects participation in the study or evaluation of the study results • Any psychological, familial or geographic situation that interferes in the adequate follow-up and adherence to the study protocol.
结局指标
主要结局
• Proportion of patients with ACR 20 response (≥20% improvement in the ACR core criteria) at end of 12 weeks study treatments
时间窗: 0, 2, 4, 6, 8 and 12 weeks
次要结局
- •Compare incidence and titres of anti-adalimumab antibodies between treatment groups(-3, 12 and 24 weeks)
- • Change from baseline in IL-6 and TNF-alpha levels at the end of study treatments(-3 and 12 weeks)
- •Change from baseline in Health Assessment Questionnaire (HAQ-DI) at the end of study treatments(0, 2, 4, 6, 8, 12, 16, 20 and 24 weeks)
- •Proportion of patients with an ACR 50 and ACR 70 response (≥50%, ≥70% improvement in the ACR core criteria) at the end of study treatments(0, 2, 4, 6, 8, 12, 16, 20 and 24 weeks)
- • Change from baseline in Disease Activity Score 28 C-Reactive Protein (DAS 28-CRP) at the end of study treatments(0, 2, 4, 6, 8, 12, 16, 20 and 24 weeks)
- • Proportion of patients with ACR 20 response (≥20% improvement in the ACR core criteria at 24 weeks (maximum study treatment duration)(16, 20 and 24 weeks)
- •Safety will be measured by adverse events, by monitoring of significant clinical signs and symptoms, and laboratory abnormalities during treatment(All visits)
- •Compare the single dose pharmacokinetic parameters of Cmax, AUC0-t, AUC0-inf, Kelt1/2, Tmax, CL, and Vd(Single dose at 0 week)
研究者
研究点 (19)
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