CTRI/2019/09/021078
Active, not recruiting
Phase 4
A prospective, multi-centre, open label, phase IV studyto evaluate safety and efficacy profile of Infimabâ?¢ in patients with moderate to severe plaque psoriasis
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: L400- Psoriasis vulgaris
- Sponsor
- Reliance Life Sciences Pvt Ltd
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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