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

Merck Sharp & Dohme LLC0 sites22 target enrollmentMay 30, 2006

ConditionsPsoriasis

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Psoriasis
Sponsor: Merck Sharp & Dohme LLC
Enrollment: 22
Primary Endpoint: Psoriasis Area and Severity Index 75 (PASI75) Response at Week 10
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 30, 2006

End Date

November 11, 2008

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Merck Sharp & Dohme LLC

Responsible Party

Sponsor

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.

Outcomes

Primary Outcomes

Psoriasis Area and Severity Index 75 (PASI75) Response at Week 10

Time Frame: 10 weeks

PASI 75 response is defined as participants who achieved at least a 75% improvement in PASI score from Baseline to Week 10. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72 (the higher the number, the worse the disease).