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

This study has been completed.
Sponsor:
Collaborator:
Centocor, Inc.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00687401
First received: May 27, 2008
Last updated: November 27, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Psoriasis
Biological: Infliximab
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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).



Enrollment: 215
Study Start Date: June 2006
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00687401     History of Changes
Other Study ID Numbers: P04612
Study First Received: May 27, 2008
Results First Received: December 2, 2010
Last Updated: November 27, 2013
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Infliximab
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents
Antirheumatic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 20, 2014