The purpose of this research study is to evaluate the safety and effectiveness profile of the medicine named as Infimabâ?¢ in patients with moderate to severe plaque psoriasis which is a skin disease characterized by raised red patches covered with a silvery white buildup of dead skincells or scale
- Conditions
- Health Condition 1: L400- Psoriasis vulgaris
- Registration Number
- CTRI/2019/09/021078
- Lead Sponsor
- Reliance Life Sciences Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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
syndrome
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
months.
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
study.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of adverse events occurring during the studyTimepoint: Baseline to Week 14
- Secondary Outcome Measures
Name Time Method Change in Physician Global Assessment (PGA) score from baseline to week 14Timepoint: From baseline to Week 14;Change in Psoriasis Area and Severity Index (PASI) score from baseline to week 14Timepoint: From baseline to Week 14