A Study to Evaluate Remicade (Infliximab) in Moderate-to-Severe Chronic Plaque Psoriasis in the Middle Eastern Population (Study P04528)

A Multicenter, Multinational, Open Label Study on the Efficacy and Safety of Infliximab Monotherapy in Moderate-to-severe Chronic Plaque Psoriasis in Middle Eastern Population

Middle Eastern subjects with moderate-to-severe chronic plaque psoriasis will be administered infusions of infliximab (Remicade) at 5 mg/kg of body weight at Weeks 0, 2, 6, 14, and 22. The safety and efficacy of infliximab monotherapy will be evaluated.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 18 years or older, either gender, and any race.
• Psoriasis affecting >=5% of body surface, PASI score >=10 (maximum score 72).
• History of plaque psoriasis for >6 months.
• Informed written consent.
• Refractory to other anti-psoriasis agents (topical corticosteroids, phototherapy UVa [PUVA], or systemic therapy).
• Negative chest x-ray and purified protein derivative (PPD) within 1 month.
• Understand and be able to adhere to dosing and visit schedules.
• Screening laboratory tests must meet protocol-specified criteria.
• Women and men of childbearing potential must be using adequate birth control measures and should continue such precautions for 6 months after last infusion of infliximab.

Exclusion Criteria:

• Pregnant, nursing, or planned pregnancy within 6 months after last scheduled treatment.
• Used topical corticosteroids in previous 14 days or systemic therapy (phototherapy UVb [UVB], PUVA, cyclosporine, methotrexate) in previous 28 days, or received treatment with anti-tumor necrosis factor (TNF)-alpha monoclonal antibodies, human or murine immunoglobulins, TNF-alpha receptor fusion proteins, or other bioengineered fusion proteins.
• Received previous immunobiologics.
• Have HIV, hepatitis B or C.
• Recently transplanted (exception - corneal transplant >3 months prior to first infusion) or known malignancy or history of malignancy within previous 5 years (exception - basal or squamous cell carcinoma of skin that has been treated with no evidence of recurrence).
• Concurrent medications that are not permitted.
• congestive heart failure (CHF)
• Use of cyclosporine or tacrolimus within 4 weeks prior to Screening.
• Use of intramuscular (IM), intravenous (IV), or oral corticosteroids within 4 weeks prior to Screening.
• Treatment with any investigational drug within 3 months prior to Screening.
• Allergy to murine proteins.
• Serious infections (hepatitis, pneumonia, pyelonephritis) in previous 3 months.
• History of active tuberculosis (TB) requiring treatment within previous 3 years, or history of opportunistic infections (herpes zoster) within 2 months of Screening.
• Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurological or cerebral disease.
• Current signs or symptoms of other severe uncontrolled disease which in investigator's opinion would put the subject at an unacceptable risk.
• History of current alcohol or drug abuse.
• Not observed designated washout periods for any of the prohibited medications in protocol.

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 given as an infusion at Weeks 0, 2, 6, 14, and 22.	Biological: Infliximab; Infliximab 5 mg/kg of body weight given as an infusion at Weeks 0, 2, 6, 14, and 22.; Other Names: Remicade, SCH 215596

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psoriasis Area and Severity Index 75 (PASI75) Response at Week 10	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 response 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

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2006
• Primary Completion (Actual): November 11, 2008
• Study Completion (Actual): November 11, 2008

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): May 10, 2017
• Last Update Submitted That Met QC Criteria: April 4, 2017
• Last Verified: April 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: P04528

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