CTRI/2019/10/021694
Active, not recruiting
Phase 4
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 sites0 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: L400- Psoriasis vulgaris
- Sponsor
- Reliance Life Sciences Pvt Ltd RLS
- Status
- Active, not recruiting
- Last Updated
- 3 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 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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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