A Study to Evaluate Infliximab in Subjects With Moderate-to-Severe Psoriasis Not Responding to Standard or Biologic Therapy (Study P04612)

Psoriasis Clinical Trial

— ESAQUALITY  

Official title:

A Multi-center, Open Label Trial Evaluating the Efficacy , SAfety and the Impact on QUAlity of Life of Infliximab TherapY in Patients With Moderate-to-severe Psoriasis Not Responding to Standard or Biologic Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00687401
• Other study ID #: P04612
• Status: Completed
• Phase: Phase 3
• First received: May 27, 2008
• Last updated: October 19, 2015
• Start date: June 2006
• Est. completion date: May 2009

Study information

• Verified date: October 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Subjects with moderate-to-severe chronic psoriasis not responding to standard or biologic therapy will be eligible to enroll in this study. Subjects will receive infliximab infusions (5 mg/kg of body weight) at Weeks 0, 2, 6, and 14 followed by a 12-week follow-up period. The efficacy of infliximab will be evaluated by the Psoriasis Area and Severity Index (PASI).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 215
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• >=18 to 75 years of age, of either gender, and of any race.

• Psoriasis covering at least 10% of total body surface area (BSA) and PASI >=12 at Screening and Baseline.

• Diagnosis of moderate-to-severe psoriasis at least 6 months prior the screening.

• Eligible to infliximab who have failed at least 1 of the following: corticosteroids, methotrexate (MTX), systemic retinoids, cyclosporine, psoralen-ultraviolet A (PUVA), ultraviolet B (UVB) phototherapy, and/or biologics (etanercept or efalizumab).

• Eligible according to tuberculosis (TB) eligibility assessment, screening and early detection of reactivation rules.

• Chest x-ray within 3 months prior to Screening with no evidence of malignancy, infection, or fibrosis.

• Screening and Baseline tests (complete blood count [CBC], blood chemistry, and urinalysis) must be within protocol-specified parameters.

• Free of significant disease that could interfere with study evaluations.

• Willing to give written informed consent and able to adhere to protocol visits and procedures.

• Women of childbearing potential and all men must be using adequate birth control and must continue to do so for 6 months after receiving the last dose of study medication.

• Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline.

Exclusion Criteria:

• Standard concomitant psoriasis therapies.

• Active or latent TB.

• History of chronic infectious disease, opportunistic infection, or serious infection within 2 months of enrollment.

• History of lymphoproliferative disease.

• Malignancy in past 5 years (except treated basal cell carcinoma [BCC]).

• Treatment with tumor necrosis factor (TNF) antagonists within previous 6 weeks.

• Current drug-induced psoriasis.

• Females who are pregnant or nursing and females and males who are planning pregnancy within 6 months from the last infusion of infliximab.

• Previously treated with infliximab.

• Concomitant diagnosis of congestive heart failure (CHF) including medically-controlled asymptomatic subjects.

• History of chronic or recurrent infectious disease.

• Have or have had a serious infection or have been hospitalized or received intravenous antibiotics for an infection during the 2 months prior to Screening.

• Have or have had an opportunistic infection within 6 months prior to Screening.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Biological:
• Infliximab
Infliximab 5 mg/kg of body weight administered as an infusion at Weeks 0, 2, 6 (induction phase), and 14 (maintenance phase).

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.	Centocor, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Achieve a Greater Than or Equal to 75% Improvement in Psoriasis Area and Severity Index (PASI) Score	PASI 75 response is defined as participants who achieved at least a; 75% improvement in PASI score from Baseline to Week 10. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their responses to therapy. The PASI produces a numeric score that can range from 0 to 72 (the higher the number, the worse the disease).	10 weeks	No