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

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.
ClinicalTrials.gov Identifier: NCT00687362
Recruitment Status : Completed
First Posted : May 30, 2008
Results First Posted : March 9, 2010
Last Update Posted : May 10, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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 or disease Intervention/treatment Phase
Psoriasis Biological: Infliximab Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : May 30, 2006
Primary Completion Date : November 11, 2008
Study Completion Date : November 11, 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Infliximab
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Psoriasis Area and Severity Index 75 (PASI75) Response at Week 10 [ 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 response 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 and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00687362     History of Changes
Other Study ID Numbers: P04528
First Posted: May 30, 2008    Key Record Dates
Results First Posted: March 9, 2010
Last Update Posted: May 10, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php


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