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

NCT ID: NCT00687401

Last Updated: 2017-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 215 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2009-05-31

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).

Conditions

Psoriasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Infliximab 5 mg/kg

Infliximab 5 mg/kg of body weight administered as an infusion at Weeks 0, 2, 6, and 14.

Group Type: EXPERIMENTAL

Infliximab

Intervention Type: BIOLOGICAL

Infliximab 5 mg/kg of body weight administered as an infusion at Weeks 0, 2, 6 (induction phase), and 14 (maintenance phase).

Interventions

Infliximab

Infliximab 5 mg/kg of body weight administered as an infusion at Weeks 0, 2, 6 (induction phase), and 14 (maintenance phase).

Intervention Type: BIOLOGICAL

Other Intervention Names

Remicade, SCH 215596

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centocor, Inc.

INDUSTRY

Sponsor Role: collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

P04612

Identifier Type: -

Identifier Source: org_study_id