Back to resultsA Study to Evaluate Remicade (Infliximab) in Moderate-to-Severe Chronic Plaque Psoriasis in the Middle Eastern Population (Study P04528)
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Infliximab
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Infliximab 5 mg/kg
Arm Description
Infliximab 5 mg/kg of body weight given as an infusion at Weeks 0, 2, 6, 14, and 22.
Outcomes
Primary Outcome Measures
Psoriasis Area and Severity Index 75 (PASI75) Response at Week 10
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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00687362
Brief Title
A Study to Evaluate Remicade (Infliximab) in Moderate-to-Severe Chronic Plaque Psoriasis in the Middle Eastern Population (Study P04528)
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
May 30, 2006 (Actual)
Primary Completion Date
November 11, 2008 (Actual)
Study Completion Date
November 11, 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Infliximab 5 mg/kg
Arm Type
Experimental
Arm Description
Infliximab 5 mg/kg of body weight given as an infusion at Weeks 0, 2, 6, 14, and 22.
Intervention Type
Biological
Intervention Name(s)
Infliximab
Other Intervention Name(s)
Remicade, SCH 215596
Intervention Description
Infliximab 5 mg/kg of body weight given as an infusion at Weeks 0, 2, 6, 14, and 22.
Primary Outcome Measure Information:
Title
Psoriasis Area and Severity Index 75 (PASI75) Response at Week 10
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
A Study to Evaluate Remicade (Infliximab) in Moderate-to-Severe Chronic Plaque Psoriasis in the Middle Eastern Population (Study P04528)
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