CTRI/2021/07/034531已完成3 期
A Prospective, Randomized, Double Blind, Multidose, Multicenter, Parallel Group, Active Controlled Phase III Study to Compare Clinical Efficacy and Safety of Shilpa Adalimumab with Humira® (Adalimumab) in Patients with Active Rheumatoid Arthritis.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 26
- 主要终点
- The percentage of patients with an ACR20 response rate in both the treatment groups.
研究概览
简要总结
This is a prospective, randomized, double blind, multi dose, multicenter, parallel group, comparative clinical efficacy and safety study in patients with Active Rheumatoid Arthritis in between Shilpa Adalimumab (test) 40mg/0.4 ml prefilled Syringe from Shilpa Biologicals Private Limited and Humira® (Reference Adalimumab) 40mg/0.4 ml prefilled Syringe from AbbVie Deutschland GmbH & Co. KG administrated Subcutaneously till week 24 (12 doses, alternate week). Patients will be randomized in a ratio of 2:1 (120 in test arm and 60 reference arm).
History of rheumatoid arthritis, as defined by the American College of Rheumatology (ACR) 2010 Criteria, for at least 3 months
History of treatment with Methotrexate (MTX) 20-25 mg per week for atleast 12 weeks before screening, and being at stable dose for atleast 4 weeks before screening will be invited to participate in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and 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
- •1.Adult men and women patients with age ≥18 years and ≤ 65 years of age at the time of screening.
- •2.Patient should have been diagnosed with active Rheumatoid Arthritis as per 2010 American College of Rheumatology Criteria atleast 3 months prior to screening.
- •3.Patient with moderate to severe active disease defined as Disease Activity Score 28 (DAS 28) ≥ 3.2 despite standard anti-rheumatic DMARD treatment including atleast Methotrexate.
- •4.History of treatment with Methotrexate (MTX) 20-25 mg per week for atleast 12 weeks before screening, and being at stable dose for atleast 4 weeks before screening.
- •5.If the patients are on oral glucocorticoid (< 10 mg/day of prednisone or equivalent) then the dose must be stable for at least 4 weeks before screening.
- •If they are not taking glucocorticoid currently then they must have not received glucocorticoid for atleast 4 weeks prior to screening.
- •6.If patients are using NSAIDs, they should have been on a stable dose for at least 4 weeks prior to screening.
- •7.Male or female patients of child-bearing potential must agree to use medically acceptable forms of contraception during the study.
- •8.Able to self-administer injection or with help of assistant.
- •9.Patients able to understand and voluntarily provide written informed consent before screening, following an explanation of the nature and purpose of this study.
排除标准
- •1.Known hypersensitivity to Adalimumab or any of its excipients or related group of drugs.
- •2.Prior treatment with other biological response modifiers (e.g. Adalimumab, infliximab and anakinra) within 3 months from screening.
- •3.Autoimmune disease other than RA or patients with significant systemic manifestations of RA.
- •4.Pregnant or Nursing female patients.
- •5.History of diagnosis of juvenile rheumatoid arthritis (JRA) and/or RA before age
- •6.History of inflammatory arthritis other than RA (e.g., systemic lupus erythematosus (SLE), or psoriatic arthritis).
- •7.Any surgical procedure for the disease, including bone/joint surgery or planned surgery within 8 weeks prior to screening or during the study period.
- •8.History of use of disease-modifying anti-rheumatic drugs (DMARDs) other than MTX within 4 weeks prior to randomization (8 weeks’ prior for Leflunomide).
- •10.Use of intra-articular or parenteral corticosteroids within 4 weeks prior to screening visit.
- •Inhaled corticosteroids for stable medical conditions are allowed.
- •11.Receipt of a live vaccine within 4 weeks prior to enrolment visit.
- •13.Evidence of significant uncontrolled concomitant diseases such as cardiovascular disease, nervous system, renal, hepatic, endocrine, gastrointestinal, or pulmonary disease, including any pulmonary or other condition that would preclude subject participation.
- •14.Known active bacterial, viral, fungal, mycobacterial, or other infection (including tuberculosis or atypical mycobacterial disease, but excluding fungal infections of nail beds).
结局指标
主要结局
The percentage of patients with an ACR20 response rate in both the treatment groups.
时间窗: week 24
次要结局
- 1.Percentage of patients with an ACR 20 response rate in both treatment groups(2.Percentage of patients with ACR20 ACR70 response rate in both treatment groups)
研究者
研究点 (26)
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