CTRI/2019/10/021694进行中（未招募）4 期
A prospective, multi-centre, open label, phase IV study to evaluate safety and efficacy profile of AdaliRel�® in patients with moderate to severe plaque psoriasis
Reliance Life Sciences Pvt Ltd RLS0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Patients aged between 18 to 65 years (both inclusive)
- •2. Patients with confirmed diagnosis of plaque psoriasis since at least 6 months
- •3. Patients with moderate to severe plaque psoriasis with ââ?°Â¥10% BSA involvement and PASI ââ?°Â¥12
- •4. Physicianââ?¬•s Global Assessment (PGA) of at least moderate disease severity
- •5. Women of childbearing potential and men agreeing to use adequate contraception
- •6. Patients able to understand and willing to provide written informed consent
排除标准
- •1. Patients with hypersensitivity to Adalimumab or any of its components.
- •2. Pregnant or lactating females
- •3. Presence of serious or active infection due to bacteria, fungi, viruses or other opportunistic pathogens
- •4. History of serious infection, which caused hospitalization within 6 months prior to randomization or other severe or chronic infection (such as sepsis, abscess or opportunistic infections, invasive fungal infection such as histoplasmosis, or a history of recurrent herpes zoster or other chronic or recurrent infection) or a past diagnosis without sufficient documentation of complete resolution following treatment.
- •5. Infection requiring parenteral antibiotic treatment within 4 weeks of randomization.
- •6. Patients with history of any malignancy diagnosed within last 5 years or presence of any premalignant lesions
- •7. Patients with heart failure (New York Heart Association class III or IV)
- •8. Patients with known hematological disorders, demyelinating disease or lupus-like syndrome
- •9. Patients with known clinically significant liver disease
- •10. Known cases of HIV, Hepatitis B or Hepatitis C infection
- •11. Active TB. Also excluded are subjects who have evidence of latent TB [evidence of tuberculosis based on chest X rays, tuberculin skin (Mantoux) test, QuantiFERONÃ?®-TB Gold test or other tuberculosis test performed during screening] without adequate therapy for TB completed prior to first infusion of Study Medication. Also excluded are subjects with evidence of an old or latent TB infection without documented adequate therapy, if they will not be treated with antitubercular therapy during the study. Subjects with a current close contact with an individual with active TB will also be excluded. Additionally, subjects who have completed treatment for active TB within the previous 2 years are explicitly excluded from the study. Subjects with a household member who has a history of active pulmonary TB, which has been treated, should have had a thorough evaluation for TB prior to study enrolment as recommended by a local infectious disease specialist or published local guidelines of TB control agencies. Also excluded are subjects with opportunistic infections including, but not limited to, evidence of active cytomegalovirus, active pneumocystis carinii, aspergillosis, or atypical mycobacterial infection, etc., within the previous 6 months.
- •12. Patients with any condition that might make it difficult for patients to participate in the study or that might affect interpretation of results of the study, at the discretion of Investigator.
- •13. Participation in any clinical study of an investigational product within previous 3 months.
- •14. Current signs or symptoms of significant, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic or cerebral disease that renders the patient incapable of participating in the study.
研究者
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