Status:
COMPLETED
A Study to Evaluate Remicade (Infliximab) in Moderate-to-Severe Chronic Plaque Psoriasis in the Middle Eastern Population (Study P04528)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 30 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 11 2008
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00687362
Start Date
May 30 2006
End Date
November 11 2008
Last Update
May 10 2017
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