NCT00686595已完成4 期
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)
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 48
- 主要终点
- Psoriasis Area and Severity Index (PASI) 75 Response Rate at Week 10
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>=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.
排除标准
- •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
- •Have or have had opportunistic infection within 6 months prior to Visit
- •Have or have had herpes zoster infection within 2 months prior to Visit
- •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.
结局指标
主要结局
Psoriasis Area and Severity Index (PASI) 75 Response Rate at Week 10
时间窗: Baseline and 10 weeks
PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 75 response rate at Week 10 is measured as the percentage of participants who achieved at least 75% improvement from baseline PASI at Week 10.
次要结局
- Percent Reduction in Self-Administered Psoriasis Area Severity Index (SAPASI) at Week 18(Baseline and Week 18)
- PASI 50 Response Rate at Week 10(Baseline and 10 weeks)
- PASI 75 Response Rate at Week 18(Baseline and 18 weeks)
- PASI 50 Response Rate at Week 18(Baseline and 18 weeks)
- Percent Reduction in SKINDEX-29 Scores at Week 24(Baseline and Week 24)
- PASI 50 Response Rate at Week 24(Baseline and 24 weeks)
- PASI 90 Response Rate at Week 18(Baseline and 18 weeks)
- PASI 100 Response Rate at Week 18(Baseline and 18 weeks)
- Percent Reduction in SAPASI at Week 24(Baseline and Week 24)
- PASI 75 Response Rate at Week 24(Baseline and 24 weeks)
- PASI 90 Response Rate at Week 10(Baseline and 10 weeks)
- PASI 90 Response Rate at Week 24(Baseline and 24 weeks)
- PASI 100 Response Rate at Week 24(24 weeks)
- Percent Reduction in Dermatology Life Quality Index (DLQI) Total Score at Week 18(Baseline and Week 18)
- PASI 100 Response Rate at Week 10(Baseline and 10 weeks)
- Percent Reduction in Affected Body Surface Area (BSA) at Week 18(Baseline and Week 18)
- Percent Reduction in Visual Analogue Scale (VAS) Referred Itch at Week 18(Baseline and Week 18)
- Percent Reduction in Affected BSA at Week 24(Baseline and Week 24)
- Percent Reduction in VAS Referred Itch at Week 24(Baseline and Week 24)
- Percent Reduction in DLQI Total Score at Week 24(Baseline and Week 24)
- Percent Reduction in Skin Index Questionnaire (SKINDEX-29) Score at Week 18(Baseline and Week 18)
研究者
相似试验
进行中（未招募）
不适用
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) - TANGOPatients with moderate to severe psoriasi.MedDRA version: 9.1Level: LLTClassification code 10037153Term: PsoriasisEUCTR2007-000535-26-ITSCHERING-PLOUGH100
进行中（未招募）
不适用
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) - TANGOmoderate to severe psoriasis that are resistent to etanercept ab initio or have failed 24 weeks of treatment with etanerceptMedDRA version: 9.1Level: LLTClassification code 10037153Term: PsoriasisEUCTR2007-000535-26-BESchering Plough S.p.A.100
已完成
3 期
COMMIT (Combination Of Maintenance Methotrexate-Infliximab Trial)Crohn's DiseaseNCT00132899University of Western Ontario, Canada128
已完成
3 期
Abatacept and Infliximab in Combination With Methotrexate in Subjects With Rheumatoid ArthritisRheumatoid ArthritisNCT00095147Bristol-Myers Squibb431
终止
3 期
Efficacy of Infliximab in the Treatment of Patients Affected by Corticodependent Crohn's Disease (P02732)Crohn's DiseaseNCT00796250Merck Sharp & Dohme LLC9