Clinical trial NCT00687362: A Study to Evaluate Remicade (Infliximab) in Moderate-to-Severe Chronic Plaque Psoriasis in the Middle Eastern Population (Study P04528)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-05-30
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Psoriasis Area and Severity Index 75 (PASI75) Response at Week 10
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: