Clinical trial NCT00686595: A Study to Evaluate the Switch From Etanercept to Infliximab in Subjects With Moderate-to-Severe Psoriasis (Study P05133)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Psoriasis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: Centocor, Inc.
First posted: 2008-05-30
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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).


Eligibility 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.

Primary outcomes:
measure: Psoriasis Area and Severity Index (PASI) 75 Response Rate at Week 10
timeFrame: Baseline and 10 weeks
Secondary outcomes:
measure: PASI 75 Response Rate at Week 18
timeFrame: Baseline and 18 weeks
measure: PASI 75 Response Rate at Week 24
timeFrame: Baseline and 24 weeks
measure: PASI 50 Response Rate at Week 10
timeFrame: Baseline and 10 weeks
measure: PASI 50 Response Rate at Week 18
timeFrame: Baseline and 18 weeks
measure: PASI 50 Response Rate at Week 24
timeFrame: Baseline and 24 weeks
measure: PASI 90 Response Rate at Week 10
timeFrame: Baseline and 10 weeks
measure: PASI 90 Response Rate at Week 18
timeFrame: Baseline and 18 weeks
measure: PASI 90 Response Rate at Week 24
timeFrame: Baseline and 24 weeks
measure: PASI 100 Response Rate at Week 10
timeFrame: Baseline and 10 weeks
measure: PASI 100 Response Rate at Week 18
timeFrame: Baseline and 18 weeks
measure: PASI 100 Response Rate at Week 24
timeFrame: 24 weeks
measure: Percent Reduction in Self-Administered Psoriasis Area Severity Index (SAPASI) at Week 18
timeFrame: Baseline and Week 18
measure: Percent Reduction in SAPASI at Week 24
timeFrame: Baseline and Week 24
measure: Percent Reduction in Affected Body Surface Area (BSA) at Week 18
timeFrame: Baseline and Week 18
measure: Percent Reduction in Affected BSA at Week 24
timeFrame: Baseline and Week 24
measure: Percent Reduction in Visual Analogue Scale (VAS) Referred Itch at Week 18
timeFrame: Baseline and Week 18
measure: Percent Reduction in VAS Referred Itch at Week 24
timeFrame: Baseline and Week 24
measure: Percent Reduction in Dermatology Life Quality Index (DLQI) Total Score at Week 18
timeFrame: Baseline and Week 18
measure: Percent Reduction in DLQI Total Score at Week 24
timeFrame: Baseline and Week 24
measure: Percent Reduction in Skin Index Questionnaire (SKINDEX-29) Score at Week 18
timeFrame: Baseline and Week 18
measure: Percent Reduction in SKINDEX-29 Scores at Week 24
timeFrame: Baseline and Week 24
Other outcomes:
Locations:
Study officials:
References:
citation: Ayala F, Lambert J; TANGO Study Group. Efficacy, tolerability and safety of switching from etanercept to infliximab for the treatment of moderate-to-severe psoriasis: A multicenter, open-label trial (TANGO). J Dermatolog Treat. 2015;26(4):304-11. doi: 10.3109/09546634.2014.952611. Epub 2014 Sep 18.