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

NCT00687362 | Completed Phase 2 Results

• 1 other identifier: P04528
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Infliximab 5 mg/kg

EXPERIMENTAL

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

Biological: Infliximab

Interventions

Infliximab BIOLOGICAL

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

Also known as: Remicade, SCH 215596

Infliximab 5 mg/kg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Psoriasis

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2008
• First Posted: May 30, 2008
• Study Start: May 30, 2006
• Primary Completion: November 11, 2008
• Study Completion: November 11, 2008
• Last Updated: May 10, 2017
• Results First Posted: March 9, 2010

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share