Status:
COMPLETED
A Study to Evaluate the Switch From Etanercept to Infliximab in Subjects With Moderate-to-Severe Psoriasis (Study P05133)
Lead Sponsor:
Merck Sharp & Dohme LLC
Collaborating Sponsors:
Centocor, Inc.
Conditions:
Psoriasis
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
This study will evaluate the efficacy, tolerability, and effect on the quality of life of infliximab in adults with moderate-to-severe psoriasis who are resistant to etanercept after 12 weeks of treat...
Eligibility Criteria
Inclusion
- \>=18 to 75 years of age at Screening, either sex, and any race.
- Diagnosis of moderate-to-severe plaque psoriasis \>6 months prior to Screening.
- Resistant (after 12 weeks) or failed 24 weeks of etanercept treatment.
- Not reached PASI 75 at Screening Visit after 24 weeks of etanercept treatment or resistant to etanercept.
- Agree to avoid prolonged sun exposure or artificial ultraviolet light sources during study.
- Satisfy requirements of Screening and tuberculosis (TB) test as specified in protocol.
- Chest x-ray at Visit 1 or within 3 months prior to Visit 1 with no evidence of malignancy, infection, or fibrosis.
- Laboratory tests must be within protocol-specified parameters.
- Free of any clinically significant disease that would interfere with study evaluations.
- Willing to participate and adhere to study procedures by signing written informed consent.
- Women of childbearing potential and all men must be using adequate birth control measures and continue to do so until 6 months after receiving last dose of study medication.
- Females of childbearing potential must have negative serum pregnancy test at Visit 1 and negative urine pregnancy test at Visit 2.
Exclusion
- Achieve PASI 75 or have BSA \<10% after 24 weeks of etanercept.
- Current drug-induced psoriasis.
- Females who are pregnant or nursing and both males and females who are planning pregnancy during study period or during 6 months after receiving last dose of study medication.
- Previously treated with infliximab.
- Currently taking or have taken protocol-specified prohibited drugs within specified time frame prior to Baseline.
- Congestive Heart Failure (CHF)
- Chronic or recurrent infectious disease.
- Have or have had serious infection, or been hospitalized or received IV antibiotics for this infection during the 2 months prior to Visit 1.
- Have or have had opportunistic infection within 6 months prior to Visit 1.
- Have or have had herpes zoster infection within 2 months prior to Visit 1.
- Human Immunodeficiency Virus (HIV), hepatitis B or C.
- History of any clinically significant adverse events (AEs) to murine or chimeric proteins or human/murine recombinant products.
- Current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, cerebral, or psychiatric disease.
- History of demyelinating disease or symptoms suggestive of multiple sclerosis or optic neuritis.
- Current signs and symptoms or history of systemic lupus erythematosus.
- Transplanted organ (exception - corneal transplant \>3 months prior to Visit 1).
- History of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location.
- Malignancy within previous 5 years (exception - basal cell carcinoma of skin that has been treated with no evidence of recurrence).
- Unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access to veins.
- Have had substance abuse (drug or alcohol) problem within previous 3 years.
- History of any clinically significant adverse reactions (including allergic reactions) to paracetamol/acetaminophen or histamine H1 receptor antagonist.
- In a situation or have a condition that, in opinion of investigator, may interfere with optimal participation in study.
- Used investigational drugs within 4 weeks of Screening.
- Participating in any other clinical study.
- Staff personnel directly involved with this study.
- Family members of investigational study staff.
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00686595
Start Date
October 1 2007
End Date
October 1 2009
Last Update
August 9 2023
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