A Study to Evaluate Infliximab in Subjects With Moderate-to-Severe Psoriasis Not Responding to Standard or Biologic Therapy (Study P04612) (ESAQUALITY)

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 3

Conditions

Psoriasis

Treatments

Biological: Infliximab

Study type

Interventional

Funder types

Industry

Identifiers

NCT00687401

P04612

Details and patient eligibility

About

Subjects with moderate-to-severe chronic psoriasis not responding to standard or biologic therapy will be eligible to enroll in this study. Subjects will receive infliximab infusions (5 mg/kg of body weight) at Weeks 0, 2, 6, and 14 followed by a 12-week follow-up period. The efficacy of infliximab will be evaluated by the Psoriasis Area and Severity Index (PASI).

Enrollment

215 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

>=18 to 75 years of age, of either gender, and of any race.
Psoriasis covering at least 10% of total body surface area (BSA) and PASI >=12 at Screening and Baseline.
Diagnosis of moderate-to-severe psoriasis at least 6 months prior the screening.
Eligible to infliximab who have failed at least 1 of the following: corticosteroids, methotrexate (MTX), systemic retinoids, cyclosporine, psoralen-ultraviolet A (PUVA), ultraviolet B (UVB) phototherapy, and/or biologics (etanercept or efalizumab).
Eligible according to tuberculosis (TB) eligibility assessment, screening and early detection of reactivation rules.
Chest x-ray within 3 months prior to Screening with no evidence of malignancy, infection, or fibrosis.
Screening and Baseline tests (complete blood count [CBC], blood chemistry, and urinalysis) must be within protocol-specified parameters.
Free of significant disease that could interfere with study evaluations.
Willing to give written informed consent and able to adhere to protocol visits and procedures.
Women of childbearing potential and all men must be using adequate birth control and must continue to do so for 6 months after receiving the last dose of study medication.
Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline.

Exclusion criteria

Standard concomitant psoriasis therapies.
Active or latent TB.
History of chronic infectious disease, opportunistic infection, or serious infection within 2 months of enrollment.
History of lymphoproliferative disease.
Malignancy in past 5 years (except treated basal cell carcinoma [BCC]).
Treatment with tumor necrosis factor (TNF) antagonists within previous 6 weeks.
Current drug-induced psoriasis.
Females who are pregnant or nursing and females and males who are planning pregnancy within 6 months from the last infusion of infliximab.
Previously treated with infliximab.
Concomitant diagnosis of congestive heart failure (CHF) including medically-controlled asymptomatic subjects.
History of chronic or recurrent infectious disease.
Have or have had a serious infection or have been hospitalized or received intravenous antibiotics for an infection during the 2 months prior to Screening.
Have or have had an opportunistic infection within 6 months prior to Screening.