CTRI/2021/05/033719尚未招募3 期
A Prospective, Randomized, Multiple-Dose, Multi-Center,Comparative, Parallel Group Clinical Study to Compare the Efficacy, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Safety of Intravenous Injection of Tocilizumab (Hetero Biopharma Limited) and Reference Medicinal Product (Tocilizumab - Roche) Concomitantly Administered with Methotrexate in Patients with RheumatoidArthritis
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 210
- 试验地点
- 10
- 主要终点
- improvement in the ACR core criteria)
研究概览
简要总结
This study is a double blind, randomized, active controlled, parallel group clinical study to compare the efficacy, pharmacokinetics, pharmacodynamics, immunogenicity and safety of intravenous injection of Hetero-Tocilizumab with Reference medicinal product (RMP, Roche) 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-Tocilizumab vs Roche-Tocilizumab). All the patients will be administered either Hetero-Tocilizumab or Roche-Tocilizumab every 4 weeks at 8 mg/kg intravenously. Patients will be administered study drug every 4 weeks for up to a maximum of 24 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 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 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 with erythrocyte sedimentation rate of more than 28mm/hr measured by Westergren method and/or C-reactive protein ≥10 mg/L
- •Patients who are on NSAIDs, must be on a stable dose for at least 8 weeks prior to randomization.
- •The screening laboratory tests must be: Haemoglobin ≥9.0 g/dL, Absolute Neutrophil Count ≥2.0 × 109/L, Platelets ≥100 × 109/L, SGOT and SGPT ≤ ULN, Alkaline phosphatase levels ≤ ULN, Serum creatinine ≤1.5 mg/dL.
排除标准
- •Patients with known or suspected allergy or hypersensitivity to Tocilizumab or excipients
- •Patients with functional class IV disease as defined by the American College of Rheumatology (ACR) classification of functional status in RA
- •Patients with history of use of biological disease modifying anti-rheumatic drugs (bDMARDs) within 8 weeks prior to randomization.
- •Patients with history of intra-articular or parenteral corticosteroids use within 8 weeks prior to randomization.
- •Patients with active systemic bacterial, viral, fungal, mycobacterial, or other infections
- •Patients with history of treatment with intravenous antibiotics within 30 days or oral antibiotics within 14 days prior to randomization
- •Patients with history or signs of lymphoproliferative disease
- •Patients who received live or live-attenuated vaccine within 8 weeks prior to randomization
- •Patients with history of blood donation or blood loss of >300ml within 3 months prior to randomization.
结局指标
主要结局
improvement in the ACR core criteria)
时间窗: 8 weeks and 12 | weeks
Proportion of patients with ACR 20 response (≥20%
时间窗: 8 weeks and 12 | weeks
次要结局
- Proportion of patients with an ACR 50 and ACR 70(response (≥50%, ≥70% improvement in the ACR core)
- Change from baseline in Disease Activity Score 28((DAS28-ESR))
- Compare the single dose pharmacokinetic parameters of(Cmax, AUC0-t, AUC0-∞)
- Compare the treatment emergent adverse events by(monitoring of significant clinical signs and symptoms, and laboratory abnormalities during treatment)
- Proportion of patients with ACR 20 response (≥20%(improvement in the ACR core criteria))
研究者
研究点 (10)
Loading locations...
相似试验
招募中
3 期
Study To Test The Usage of Denosumab In Patients with Cancer spread to BoneCTRI/2022/05/042823Hetero Biopharma Limited282
已完成
3 期
A 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 ArthritisCTRI/2016/04/006884Hetero Drugs Limited120
已完成
3 期
To compare the clinical efficacy and safety of shilpa adalimumab with Humaria in patients with active Rheumatoid arthritis.CTRI/2021/07/034531Shilpa Biologicals Private Limited180
已完成
3 期
A clinical Trial in Patients with Symptomatic Gastroesophageal Reflux Disease (GERD). Clinical trial is to study efficacy, safety and tolerability of Ilaprazole 10 mg Tablet in comparison to Omeprazole 20 mg Tablet(reference product).CTRI/2009/091/001053Ajanta Pharma Ltd200
已完成
3 期
A clinical Trial in patients with Tinea pedis and Tinea cruris. Clinical trial is to study efficacy, safety and tolerability of Naftifine Hydrochloride 1% cream in comparison to Terbinafine Hydrochloride 1% cream (reference product).CTRI/2009/091/001025Ajanta Pharma Limited200