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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:
ClinicalTrials.gov Identifier:
NCT00687362
First Posted: May 30, 2008
Last Update Posted: May 10, 2017
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.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  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: 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

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 ]

    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
Actual Study Start Date: May 30, 2006
Study Completion Date: November 11, 2008
Primary Completion Date: November 11, 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00687362     History of Changes
Other Study ID Numbers: P04528
First Submitted: May 27, 2008
First Posted: May 30, 2008
Results First Submitted: February 17, 2010
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