CTRI/2022/03/041073招募中4 期
An open label, prospective, non-comparative, multicentric, phase IV clinical study to evaluate the safety, tolerability and efficacy of Iguratimod tablets 25 mg in patients with active Rheumatoid Arthritis
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 334
- 试验地点
- 12
- 主要终点
- Proportion of patients reporting incidences of AE during the study and their assessment with respect to intensity, duration, pattern and causal relationship to the study medication.
研究概览
简要总结
An open label, prospective, non-comparative, multicentric, phase IV clinical study to evaluate the safety, tolerability and efficacy of Iguratimod tablets 25 mg in patients with active Rheumatoid Arthritis
研究设计
- 研究类型
- Observational
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.Male or female patients aged between 18 and 75 years (both inclusive).
- •2.Patients who are on stable maximum tolerable dose of MTX and /OR other conventional DMARD’s since last 4 weeks.
- •3.Patients having a DAS28 score ≥ 3.2 at baseline.
- •4.Patients with ability to understand and provide written informed consent, which must have been obtained prior to screening.
- •5.Patients willing to comply with the protocol requirements.
排除标准
- •1.Patients who are hypersensitive to Iguratimod or any of its components.
- •2.Female patients who are pregnant or lactating or planning to become pregnant during the study period.
- •3.Females who are not ready to use acceptable contraceptive methods during the course of the study.
- •4.Patients who are on Biologicals for the treatment of RA.
- •5.Patients with elevated liver enzymes (SGPT, SGOT) and clinically significant impaired hepatic function.
- •6.Patients with bone marrow hypoplasia.
- •(WBC<3,500/mm3 or absolute PMNs < 1500/mm3 or platelet count <150,000/mm3) 7.Patients with estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m
- •8.Patients with known case of clinically significant psychiatric disease, cerebrovascular disease, cardiovascular disease, gastrointestinal disease, infective or any acute or chronic uncontrolled systemic diseases that may affect patient safety.
- •9.Patients with history of drug or substance (alcohol/drug) abuse within previous 1 year.
- •10.Patients with medical history of oncological conditions since last 5 years.
- •11.Patients with concurrent participation in another clinical trial within 90 days prior to signing informed consent form.
- •12.Patients with suspected inability or unwillingness to comply with the study procedures.
结局指标
主要结局
Proportion of patients reporting incidences of AE during the study and their assessment with respect to intensity, duration, pattern and causal relationship to the study medication.
时间窗: Adverse events, SAE or abnormal lab values
•Proportion of patients reporting incidences of SAE during the study and their assessment with respect to intensity, duration, pattern and causal relationship to the study medication.
时间窗: Adverse events, SAE or abnormal lab values
•Changes in laboratory safety parameters from baseline to end of the study.
时间窗: Adverse events, SAE or abnormal lab values
次要结局
- Percentage of patients meeting the American College of Rheumatology 20% and 50% (ACR20 and ACR50) response criteria at the end of the study.(•Mean reduction in DAS 28 at the end of the study.)
研究者
研究点 (12)
Loading locations...
相似试验
进行中（未招募）
4 期
A clinical trial to study effects of Teriparatide in the Treatment of Postmenopausal Osteoporosis.CTRI/2023/05/052618Enzene Biosciences Limited200
招募中
4 期
A Study to Assess the Safety and Efficacy of Centhaquine in Hypovolemic Shock PatientsHypovolemic ShockNCT05956418Pharmazz, Inc.400
招募中
4 期
A Study to Evaluate the Safety and Effectiveness of Saroglitazar 4 mg in Patients With NAFLD With ComorbiditiesNAFLDDyslipidemiasMetabolic SyndromeObesityType 2 DiabetesNCT05872269Zydus Lifesciences Limited1,500
已完成
不适用
Correlation Study Between PEST and SCORAD in Management of Atopic Dermatitis With Ceradan® RegimenAtopic DermatitisNCT02073591Hyphens Pharma Pte Ltd58
已完成
4 期
Epoprostenol for Injection in Pulmonary Arterial HypertensionPulmonary Arterial HypertensionNCT01105091Actelion30