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

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00687362
• Other study ID #: P04528
• Status: Completed
• Phase: Phase 2
• First received: May 27, 2008
• Last updated: February 12, 2015
• Start date: May 2006
• Est. completion date: November 2008

Study information

• Verified date: February 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Arab Emirates: General Authority for Health Services for Abu Dhabi
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Biological:
• Infliximab
Infliximab 5 mg/kg of body weight given as an infusion at Weeks 0, 2, 6, 14, and 22.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	10 weeks	No