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

COMPLETEDPHASE2

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

NCT00687362•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+7 more criteria

Key Dates

Start Date

May 30, 2006

Primary Completion Date

November 11, 2008

Completion Date

November 11, 2008

Last Updated

May 10, 2017

Enrollment

ACTUAL participants

Conditions

Psoriasis

Interventions

Infliximab

BIOLOGICAL

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

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Psoriasis

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RECRUITINGPHASE3

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

NCT07116967

Plaque Psoriasis

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RECRUITINGPHASE3

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 10, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis

Real-Life Evaluation of Guselkumab Dosing Interval Adjustments