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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.
May 27, 2008
May 30, 2008
February 17, 2010
March 9, 2010
May 10, 2017
May 30, 2006
November 11, 2008   (Final data collection date for primary outcome measure)
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).

Proportion of subjects that achieved a >=75% improvement from baseline visit in Psoriasis Area and Severity Index (PASI) (referred to as PASI 75) at Week 10. [ Time Frame: 10 weeks ]
Complete list of historical versions of study NCT00687362 on ClinicalTrials.gov Archive Site
Not Provided
  • Assessment of the change in Dermatology Life Quality Index (DLQI) from Baseline at Week 10 [ Time Frame: 10 weeks ]
  • Proportion of subjects achieving a Physician's Global Assessment (PGA) score of cleared (0) or minimal (1) at Week 10. [ Time Frame: 10 weeks ]
  • Safety analysis will be conducted to summarize incidence and type of adverse event, proportion of subject experiencing serious adverse events on intent to treat manner. [ Time Frame: 22 weeks ]
Not Provided
Not Provided
 
A Study to Evaluate Remicade (Infliximab) in Moderate-to-Severe Chronic Plaque Psoriasis in the Middle Eastern Population (Study P04528)
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
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.
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Psoriasis
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
Experimental: Infliximab 5 mg/kg
Infliximab 5 mg/kg of body weight given as an infusion at Weeks 0, 2, 6, 14, and 22.
Intervention: Biological: Infliximab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
November 11, 2008
November 11, 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United Arab Emirates
 
NCT00687362
P04528
No
Not Provided
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

Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP