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

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Psoriasis

Intervention: Infliximab (Biological)

Phase: Phase 4

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

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 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).

Clinical Details

Official title: swiTching From etAnercept to iNfliximab in the Treatment of Moderate to Severe Psoriasis; a Multi-center, Open Label Trial evaluatinG the Efficacy, tOlerance and Safety (TANGO)

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

Primary outcome: Psoriasis Area and Severity Index (PASI) 75 Response Rate at Week 10

Secondary outcome:

PASI 75 Response Rate at Week 18

PASI 75 Response Rate at Week 24

PASI 50 Response Rate at Week 10

PASI 50 Response Rate at Week 18

PASI 50 Response Rate at Week 24

PASI 90 Response Rate at Week 10

PASI 90 Response Rate at Week 18

PASI 90 Response Rate at Week 24

PASI 100 Response Rate at Week 10

PASI 100 Response Rate at Week 18

PASI 100 Response Rate at Week 24

Percent Reduction in Self-Administered Psoriasis Area Severity Index (SAPASI) at Week 18

Percent Reduction in SAPASI at Week 24

Percent Reduction in Affected Body Surface Area (BSA) at Week 18

Percent Reduction in Affected BSA at Week 24

Percent Reduction in Visual Analogue Scale (VAS) Referred Itch at Week 18

Percent Reduction in VAS Referred Itch at Week 24

Percent Reduction in Dermatology Life Quality Index (DLQI) Total Score at Week 18

Percent Reduction in DLQI Total Score at Week 24

Percent Reduction in Skin Index Questionnaire (SKINDEX-29) Score at Week 18

Percent Reduction in SKINDEX-29 Scores at Week 24

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Additional Information

Starting date: October 2007
Last updated: November 7, 2014

Page last updated: August 23, 2015

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