Status:
COMPLETED
A Study to Evaluate Infliximab in Subjects With Moderate-to-Severe Psoriasis Not Responding to Standard or Biologic Therapy (Study P04612)
Lead Sponsor:
Merck Sharp & Dohme LLC
Collaborating Sponsors:
Centocor, Inc.
Conditions:
Psoriasis
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- \>=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
- 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.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
215 Patients enrolled
Trial Details
Trial ID
NCT00687401
Start Date
June 1 2006
End Date
May 1 2009
Last Update
April 11 2017
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