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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00687401
Recruitment Status : Completed
First Posted : May 30, 2008
Results First Posted : December 24, 2010
Last Update Posted : April 11, 2017
Centocor, Inc.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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).

Condition or disease Intervention/treatment Phase
Psoriasis Biological: Infliximab Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 215 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2006
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Infliximab

Arm Intervention/treatment
Experimental: Infliximab 5 mg/kg
Infliximab 5 mg/kg of body weight administered as an infusion at Weeks 0, 2, 6, and 14.
Biological: Infliximab
Infliximab 5 mg/kg of body weight administered as an infusion at Weeks 0, 2, 6 (induction phase), and 14 (maintenance phase).
Other Name: Remicade, SCH 215596

Primary Outcome Measures :
  1. Number of Participants Who Achieve a Greater Than or Equal to 75% Improvement in Psoriasis Area and Severity Index (PASI) Score [ 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 responses to therapy. The PASI produces a numeric score that can range from 0 to 72 (the higher the number, the worse the disease).

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00687401     History of Changes
Other Study ID Numbers: P04612
First Posted: May 30, 2008    Key Record Dates
Results First Posted: December 24, 2010
Last Update Posted: April 11, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Additional relevant MeSH terms:
Skin Diseases, Papulosquamous
Skin Diseases
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents