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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 7, 2014
Last verified: November 2014
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 7, 2014
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous
Infliximab
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Dermatologic Agents
Gastrointestinal Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014