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

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 2

Conditions

Psoriasis

Treatments

Biological: Infliximab

Study type

Interventional

Funder types

Industry

Identifiers

NCT00687362

P04528

Details and patient eligibility

About

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.

Enrollment

22 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.
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.