A Study to Evaluate the Switch From Etanercept to Infliximab in Subjects With Moderate-to-Severe Psoriasis (Study P05133) (TANGO)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 4

Conditions: Psoriasis

Treatments: Biological: Infliximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00686595

P05133

2007-000535-26 (EudraCT Number)

Details and patient eligibility

About

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 treatment or have failed 24 weeks of treatment with etanercept. Infliximab will be administered as an intravenous infusion of 5 mg/kg at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).

Enrollment: 48 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• >=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 criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

Infliximab 5 mg/kg

Experimental group

Description:

Infliximab 5 mg/kg intravenous (IV) infusion administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).

Treatment:

Biological: Infliximab