A Study to Evaluate Remicade (Infliximab) in Moderate-to-Severe Chronic Plaque Psoriasis in the Middle Eastern Population (Study P04528)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00687362
First received: May 27, 2008
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

Middle Eastern subjects with moderate-to-severe chronic plaque psoriasis will be administered infusions of infliximab (Remicade) at 5 mg/kg of body weight at Weeks 0, 2, 6, 14, and 22. The safety and efficacy of infliximab monotherapy will be evaluated.


Condition Intervention Phase
Psoriasis
Biological: Infliximab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Multinational, Open Label Study on the Efficacy and Safety of Infliximab Monotherapy in Moderate-to-severe Chronic Plaque Psoriasis in Middle Eastern Population

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Psoriasis Area and Severity Index 75 (PASI75) Response at Week 10 [ 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 response to therapy. The PASI produces a numeric score that can range from 0 to 72 (the higher the number, the worse the disease).



Enrollment: 22
Study Start Date: May 2006
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Infliximab 5 mg/kg
Infliximab 5 mg/kg of body weight given as an infusion at Weeks 0, 2, 6, 14, and 22.
Biological: Infliximab
Infliximab 5 mg/kg of body weight given as an infusion at Weeks 0, 2, 6, 14, and 22.
Other Name: Remicade, SCH 215596

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years or older, either gender, and any race.
  • Psoriasis affecting >=5% of body surface, PASI score >=10 (maximum score 72).
  • History of plaque psoriasis for >6 months.
  • Informed written consent.
  • Refractory to other anti-psoriasis agents (topical corticosteroids, phototherapy UVa [PUVA], or systemic therapy).
  • Negative chest x-ray and purified protein derivative (PPD) within 1 month.
  • Understand and be able to adhere to dosing and visit schedules.
  • Screening laboratory tests must meet protocol-specified criteria.
  • Women and men of childbearing potential must be using adequate birth control measures and should continue such precautions for 6 months after last infusion of infliximab.

Exclusion Criteria:

  • Pregnant, nursing, or planned pregnancy within 6 months after last scheduled treatment.
  • Used topical corticosteroids in previous 14 days or systemic therapy (phototherapy UVb [UVB], PUVA, cyclosporine, methotrexate) in previous 28 days, or received treatment with anti-tumor necrosis factor (TNF)-alpha monoclonal antibodies, human or murine immunoglobulins, TNF-alpha receptor fusion proteins, or other bioengineered fusion proteins.
  • Received previous immunobiologics.
  • Have HIV, hepatitis B or C.
  • Recently transplanted (exception - corneal transplant >3 months prior to first infusion) or known malignancy or history of malignancy within previous 5 years (exception - basal or squamous cell carcinoma of skin that has been treated with no evidence of recurrence).
  • Concurrent medications that are not permitted.
  • congestive heart failure (CHF)
  • Use of cyclosporine or tacrolimus within 4 weeks prior to Screening.
  • Use of intramuscular (IM), intravenous (IV), or oral corticosteroids within 4 weeks prior to Screening.
  • Treatment with any investigational drug within 3 months prior to Screening.
  • Allergy to murine proteins.
  • Serious infections (hepatitis, pneumonia, pyelonephritis) in previous 3 months.
  • History of active tuberculosis (TB) requiring treatment within previous 3 years, or history of opportunistic infections (herpes zoster) within 2 months of Screening.
  • Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurological or cerebral disease.
  • Current signs or symptoms of other severe uncontrolled disease which in investigator's opinion would put the subject at an unacceptable risk.
  • History of current alcohol or drug abuse.
  • Not observed designated washout periods for any of the prohibited medications in protocol.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00687362     History of Changes
Other Study ID Numbers: P04528
Study First Received: May 27, 2008
Results First Received: February 17, 2010
Last Updated: March 12, 2014
Health Authority: United Arab Emirates: General Authority for Health Services for Abu Dhabi

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 23, 2014