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

NCT ID: NCT00687362

Last Updated: 2017-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-30
• Study Completion Date: 2008-11-11

Brief 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.

Conditions

Psoriasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Infliximab 5 mg/kg

Infliximab 5 mg/kg of body weight given as an infusion at Weeks 0, 2, 6, 14, and 22.

Group Type: EXPERIMENTAL

Infliximab

Intervention Type: BIOLOGICAL

Infliximab 5 mg/kg of body weight given as an infusion at Weeks 0, 2, 6, 14, and 22.

Interventions

Infliximab

Infliximab 5 mg/kg of body weight given as an infusion at Weeks 0, 2, 6, 14, and 22.

Intervention Type: BIOLOGICAL

Other Intervention Names

Remicade, SCH 215596

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

P04528

Identifier Type: -

Identifier Source: org_study_id