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

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

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).

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Biological: Infliximab

• Study Type: Interventional
• Enrollment (Actual): 215
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Infliximab 5 mg/kg; Infliximab 5 mg/kg of body weight administered as an infusion at Weeks 0, 2, 6, and 14.	Biological: Infliximab; Infliximab 5 mg/kg of body weight administered as an infusion at Weeks 0, 2, 6 (induction phase), and 14 (maintenance phase).; Other Names: Remicade, SCH 215596

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Collaborators: Centocor, Inc.

Study record dates

Study Major Dates

• Study Start: June 1, 2006
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: May 27, 2008
• First Submitted That Met QC Criteria: May 27, 2008
• First Posted (Estimate): May 30, 2008

Study Record Updates

• Last Update Posted (Actual): April 11, 2017
• Last Update Submitted That Met QC Criteria: March 13, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Antirheumatic Agents; Gastrointestinal Agents; Dermatologic Agents; Infliximab
• Other Study ID Numbers: P04612

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php