A prospective, multi-centre, open label, phase IV studyto evaluate safety and efficacy profile of Infimabâ?¢ in patients with moderate to severe plaque psoriasis

Reliance Life Sciences Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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 having PASI score >10.
•4. Women of childbearing potential agreeing to use adequate contraception.
•5. Able to understand and willing to provide written informed consent.

•1. Patients with hypersensitivity to Infliximab 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. Patients with active or latent tuberculosis
•5. Patients with history of any malignancy including lymphomas or presence of any
•premalignant lesions
•6. Patients with heart failure (New York Heart Association class III or IV)
•7. Patients with known hematological disorders, demyelinating disease or lupus-like
•8. Patients with known clinically significant liver disease
•9. Known cases of HIV, Hepatitis B or Hepatitis C infection
•10. 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.
•11. Participation in any clinical study of an investigational product within previous 3
•12. 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

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