Open label, randomized, investigator initiated clinical study to evaluate efficacy and safety of Iguratimod tablets 25mg twice daily and Leflunomide tablets 20mg as DMARD in patients with inadequate response to methotrexate and hydroxychloroquine in patients with active rheumatoid arthritis.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Number of subject achieved the DAS 28 ESR score less than 2.6
研究概览
简要总结
The study will be carried out to evaluate efficacy and safety of Iguratimod and/or Leflunomide as an addon therapy to methotrexate and HCQs in patients with active RA who have not responded to Methotrexate and Hydroxyquinone combination treatment. In the current practice by rheumatologist either leflunomide or Iguratimod is used in this situation. There are no studies which compare the efficacy of these two drugs in this situation. Usual choice is based on random choice of the clinician. The study aim to create some data to understand the choice between these two drugs in this situation. In addition the study also help to understand the safety of this drug in this circumstances
Mean change in clinical Activity DAS 28 from baseline to end of therapy [26th week plus or minus 3days] is the primary objective. Secondary objective is the achievement of remission. And the safety of the drugs
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female subjects of age of 18 to 65 years, both inclusive.
- •Subjects who had been diagnosed with active RA, according to the 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Classification Criteria for Rheumatoid Arthritis (ACR) criteria, and Disease Activity Score 28 (DAS28) greater than or equal to 3.
- •Tender joint count/swollen joint count ≥
- •Subjects meeting at least one of the following three conditions: erythrocyte sedimentation rate of at least 28 mm/hour, C-reactive protein (CRP) of at least 15 mg/liter
- •Patients who have failed the combination therapy, defined as subject who has failed to achieve remission after MTX+HCQ regime for 3 months.
- •Subject willing to sign informed consent form (ICF).
排除标准
- •Subjects treated with any biological injection within last 3 months.
- •Subjects with inadequate bone marrow function (defined as an absolute neutrophil count of not more than 2.5x10 to the power 9 per liter).
- •3.AST is greater than 1.5xULN (AST is equal to 10 to 34 IU per liter), AST greater than 1.5xULN (ALT is equal to 10 to 40 IU per liter).
- •Cr is equal to 1.534
- •WBC is less than 4x10 to the power 9 per liter, HGB less than 85 grams per liter, PLT less than 100x10 to the power 9 per liter.
- •Subjects on current therapy of Iguratimod, Leflunomide, and Sulfasalazine, either separately or in combinations thereof.
- •Subjects receiving live vaccines within 3 months prior to study entry.
- •A history of hypersensitivity to any of the study drugs.
- •Pregnant women, nursing mothers and during treatment requirements of women of childbearing age.
- •Subjects with active gastrointestinal ulceration / bleeding, or history of peptic ulcers.
- •Subjects with known or suspected positive serology for human immunodeficiency, hepatitis B or C virus.
- •Subjects with history of any malignancies.
- •Subjects suffering from severe serious hepatic, cardiovascular, renal, hematologic or endocrine diseases.
- •Subjects who have participated in other clinical studies within 3 months.
- •Any condition which are likely to hinder the compliance with the protocol.
- •Subjects suffering under treatment of any chronic infection.
- •Subject with history of intra-articular infection within last four weeks.
- •Subjects with dosage of steroids more than 7.5mg/day.
- •Patients not on a stable dose of steroids for last 1 month.
- •Rheumatic auto-immune disease other than rheumatoid arthritis/overlap syndromes.
- •Any surgery of bone fractures within 8 weeks.
- •Malignancies i.e., solid or hematological.
- •Alcohol or drug abuse within 6 months.
结局指标
主要结局
Number of subject achieved the DAS 28 ESR score less than 2.6
时间窗: 3 time points
Mean Reduction in Disease Activity Score 28 (DAS28) from baseline
时间窗: 3 time points
次要结局
- Safety of the drug(6 months)
研究者
Dr Chandrashekara S
Chanre Rheumatology and Immunology Center and Research