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

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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.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Psoriasis
Intervention Biological: Infliximab
Enrollment 22
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Infliximab 5 mg/kg
Hide Arm/Group Description Infliximab 5 mg/kg of body weight given as an infusion at Weeks 0, 2, 6, 14, and 22.
Period Title: Overall Study
Started 22
Completed 19 [1]
Not Completed 3
Reason Not Completed
Protocol Violation             2
Withdrawal by Subject             1
[1]
Completed protocol at Week 24
Arm/Group Title Infliximab 5 mg/kg
Hide Arm/Group Description Infliximab 5 mg/kg of body weight given as an infusion at Weeks 0, 2, 6, 14, and 22.
Overall Number of Baseline Participants 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants
37.05  (13.15)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Female
3
  13.6%
Male
19
  86.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Middle East Number Analyzed 22 participants
22
1.Primary Outcome
Title Psoriasis Area and Severity Index 75 (PASI75) Response at Week 10
Hide Description

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).

Time Frame 10 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Infliximab 5 mg/kg
Hide Arm/Group Description:
Infliximab 5 mg/kg of body weight given as an infusion at Weeks 0, 2, 6, 14, and 22.
Overall Number of Participants Analyzed 22
Measure Type: Number
Unit of Measure: participants
16
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Infliximab 5 mg/kg
Hide Arm/Group Description Infliximab 5 mg/kg of body weight given as an infusion at Weeks 0, 2, 6, 14, and 22.
All-Cause Mortality
Infliximab 5 mg/kg
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Infliximab 5 mg/kg
Affected / at Risk (%) # Events
Total   0/22 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Infliximab 5 mg/kg
Affected / at Risk (%) # Events
Total   11/22 (50.00%)    
Gastrointestinal disorders   
vomiting  3/22 (13.64%)  3
General disorders   
pyrexia  4/22 (18.18%)  5
Infections and infestations   
tinea versicolour  3/22 (13.64%)  3
Respiratory, thoracic and mediastinal disorders   
cough  3/22 (13.64%)  3
oropharyngeal pain  3/22 (13.64%)  3
Skin and subcutaneous tissue disorders   
psoriasis  3/22 (13.64%)  5
1
Term from vocabulary, MedDRA (12.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The PI agrees not to publish/publicly present any interim results of the Study without prior written consent of Sponsor. The PI further agrees to

provide 30 days written notice to Sponsor prior to submission for publication/presentation to allow Sponsor to review materials which report any results of the Study. Sponsor shall have the right to review/comment on

any presentation, which include editorial rights to ensure protection of confidential information, accuracy, and fair balance.

Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
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