A Randomized, Double Blind, Multi Center, Parallel Study to Evaluate the Efficacy and Safety of Tacrolimus Lipid Tablets (Manufactured By Intas Pharmaceuticals Ltd) Compared to Prograf (Tacrolimus Immediate Release Capsules-Astellas Pharma Canada, Inc) in Adult Patients with Active Rheumatoid Arthritis Who Have Resistance OR Intolerance to DMARDs.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 9
- 主要终点
- Evaluation will be done by the ACR 20% response level of improvement (ACR20) at the end of treatment.
研究概览
简要总结
Rheumatoid arthritis (RA) is a chronicprogressive inflammatory disease characterized by swelling and pain in multiplejoints. Recent guidelines for the management of RA have reinforced the primary treatment aim which is disease remission in order to reduce the structural andfunctional impact of the disease. The outlook for patients with rheumatoidarthritis has improved significantly over the last three decades with the useof disease-modifying antirheumatic drugs. However, despite theuse of methotrexate, cytokine inhibitors, and molecules targeting T and Bcells, a percentage of patients do not respond or lose their response overtime. Because of the known role of T cell activation in disease pathogenesis,the observed immunomodulating actions of tacrolimus, and the encouragingresults of many clinical trials led us to develop Tacrolimus in RA. Tacrolimusis an immunomodulator that acts by inhibiting T-cell activation. A number ofclinical studies have been reported over the last decade supporting its use inRA. Tacrolimus tablets are manufactured using lipidic excipients like SoyPhosphotidyl Choline & Sodium Chloesteryl Sulfate. These excipients areGenerally Regarded as Safe (GRAS) by United State Food & DrugAdministration (US FDA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient willing to give written, signed and dated informed consent to participate in the study before initiating any study related procedures
- •Adult patients of age 18 years or older who should meet the criteria for Rheumatoid Arthritis as per American College of Rheumatology at least for last 6 months with ACR functional class I–III
- •Sexually active women, unless surgically sterile (at least 6 months prior to study drug administration) or postmenopausal for at least 12 consecutive months, must use an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives [any hormonal method in conjunction with a secondary method], intrauterine device, emale condom with spermicide, diaphragm with spermicide, absolute sexual abstinence, use of condom with spermicide by sexual partner or sterile [at least 6 months prior to study drug administration] sexual partner) for at least 4 weeks prior to study drug administration, during tudy and up to 30 days after the last dose of study drug
- •In case of Male patients: Either patient partners or patients themselves must use an effective method of avoiding pregnancy for at least 4 weeks prior to study drug administration, during study and up to 30 days after the last dose of study drug
- •No other serious illness that according to investigator might jeopardize the well-being, the safety of patients, the compliance to study medications and validity of data generated during the study.
排除标准
- •Known hypersensitivity to Tacrolimus or any of its components
- •Patients who had received biological products with an inhibitory effect on the progression of joint destruction (e.g. Infliximab, etanercept) within 12 weeks before administration of the study drug
- •Patients who had previously received Tacrolimus for current disease
- •Pregnant or breast-feeding female
- •Clinically significant Liver disease (defined by levels of Aspartate Aminotransferase, Alanine Aminotransferase, Alkaline Phosphatase, or Total bilirubin ≥2 times the upper limit of normal)
- •Clinically significant renal disease (defined by serum creatinine (Cr) ≥2 times the upper limit of normal)
- •Clinically significant Bone marrow suppression defined as haemoglobin level <9 gm/dl, white blood cell count < 3,000/mm3, platelet count <100,000/mm3
- •Patients with Hepatitis B or C infection
- •Have active dysphagia, swallowing disorders, bowel obstruction, or severe gastrointestinal motility disorders.
- •Have any evidence of active malignancy except for basal cell carcinoma of the skin.
- •A history of malignancy is not an exclusion
- •Have participated in a study of an investigational drug during the 30 days preceding randomization.
结局指标
主要结局
Evaluation will be done by the ACR 20% response level of improvement (ACR20) at the end of treatment.
时间窗: 6 months
次要结局
- To monitor the safety of the patients who are exposed to investigational medicinal products(6 months)