Clinical trial NCT00687401: A Study to Evaluate Infliximab in Subjects With Moderate-to-Severe Psoriasis Not Responding to Standard or Biologic Therapy (Study P04612)
Official title: A Multi-center, Open Label Trial Evaluating the Efficacy , SAfety and the Impact on QUAlity of Life of Infliximab TherapY in Patients With Moderate-to-severe Psoriasis Not Responding to Standard or Biologic Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: Centocor, Inc.
First posted: 2008-05-30
Enrollment: 215
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants Who Achieve a Greater Than or Equal to 75% Improvement in Psoriasis Area and Severity Index (PASI) Score
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: