EUCTR2007-000535-26-BE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) - TANGO
Schering Plough S.p.A.0 个研究点目标入组 100 人开始时间: 2007年8月29日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Subjects must be =18 to 75 years of age at Screening, of either sex, and of any race.
- •2. Subjects must have had a diagnosis of moderate to severe plaque psoriasis at least 6 months prior to Screening (subjects with concurrent psoriatic arthritis may be enrolled).
- •3. Subjects resistant or patient who must have failed 24 weeks of treatment with etanercept. (Definition of resistant patient: patient who has not modified or presents an increase in his PASI score or BSA affected after 12 weeks of etanercept treatment. Definition of patient failure: patient who has not reached PASI 75 or presents BSA = 10 at Screening visit (V1) after 24 weeks of etanercept treatment.
- •4. Subjects who has not reached PASI 75 at Screening visit (V1) after 24 weeks of etanercept treatment or resistant ab initio to etanercept.
- •5. Subjects must agree to avoid prolonged sun exposure or artificial ultraviolet light sources during the study.
- •6. Subjects must comply with the requirements of the screening and diagnosis Tubercolosis Skin Test (according to procedure described in section 8.12 of the present protocol).
- •Subjects are considered eligible according to the following criteria:
- •a. Have no history of latent or active TB prior to screening;
- •b. Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination;
- •c. Have had no recent close contact with a person with active TB or, if there has been such contact, will be referred to a physician specializing in TB to undergo additional evaluation and, if warranted, receive appropriate treatment for latent TB prior to or simultaneously with the first administration of study medication;
- •d. Two negative tuberculin skin tests; one positive tuberculin skin test in association with appropriate treatment for latent TB initiated prior to or simultaneously with the first administration of study medication
- •7. Subjects must have had a chest x-ray (posterior-anterior and lateral) at visit 1 or within 3 months prior to vist 1 with no evidence of malignancy, infection or fibrosis.
- •8. Subjects’ Screening clinical laboratory tests must be within the following parameters:
- •a. Hemoglobin =10 g/dL
- •b. White blood cells =3.5 x 109/L
- •c. Neutrophils =1.5 x 109/L
- •d. Platelets =100 x 109/L
- •e. Serum creatinine <1.5 mg/dL
- •f. Aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, and gamma-glutamyltransferase =1.5 x upper limit of normal range
- •g. Total bilirubin =1.5 x upper limit of normal range
- •9. Subjects must be free of any clinically significant disease (other than psoriasis or psoriatic arthritis) that would interfere with the study evaluations.
- •10. Subjects must be willing to participate to the study and to adhere to study procedures by signing the written informed consent.
- •11. Women of childbearing potential and all men must be using adequate birth control measures and must continue using such measures until 6 months after receiving the last dose of study medication.
- •12. Female subjects of childbearing potential must have a negative serum pregnancy test (beta-hCG) at visit 1 and a negative urine pregnancy test at visit 2.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Subjects who achieved PASI 75 or who have had BSA < 10 after 24 weeks of etanercept treatment.
- •2. Subjects who have current drug-induced psoriasis (f.i., a new onset of psoriasis or an exacerbation of psoriasis due to iatrogenic factors).
- •3. Female subjects who are pregnant, nursing, and both men and women who are planning pregnancy during the study period or during the 6 months after receiving the last dose of study medication.
- •4. Subjects previously treated with infliximab.
- •5. Subjects who are currently taking or have taken the following drugs within the specified time frame prior to Screening (see Section 6.2):
- •a. any live or attenuated virus or bacterial vaccinations received within 3 months prior to visit 1
- •b. any systemic medications/treatments that could affect psoriasis or clinical evaluations within 4 weeks prior to visit 1.
- •c. lithium within 4 weeks prior to visit 1
- •d. any topical medications/treatments that could affect psoriasis or PASI evaluations within 2 weeks prior to visit 1. The only allowed treatments are emollient/moisturizing lotion and shampoos containing salicylic acid. Subjects should not use these topical agents the day prior to study visit. Non-medicated shampoos may be used on the day of a visit.
- •6. Subjects who have a concomitant diagnosis of congestive heart failure (CHF), including medically-controlled and or asymptomatic subjects.
- •7. Subjects who have a history of chronic or recurrent infectious disease, including: chronic renal infection, chronic chest infection (eg, bronchiectasis), recurrent urinary tract infection (recurrent pyelonephritis or chronic cystitis), open skin wounds/ulceration that are draining or infected.
- •8. Subjects who have had or have a serious infection (eg, hepatitis, pneumonia or pyelonephritis), or have been hospitalized or received intravenous (IV) antibiotics for this infection during the 2 months prior to visit 1.
- •9. Subjects who have or have had an opportunistic infection (eg, cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) within 6 months prior to Visit 1.
- •10 Subjects who have or have had a Herpes zoster infection within 2 months prior to visit 1.
- •11. Subjects who are known to be infected with human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C (HCV).
- •12. Subjects who have a history of any clinically significant AEs (including allergic reactions) to murine or chimeric proteins or human/murine recombinant products.
- •13. Subjects who have current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease.
- •14. Subjects who have a history of demyelinating disease or symptoms suggestive of multiple sclerosis or optic neuritis.
- •15. Subjects who have current signs and symptoms or history of systemic lupus erythematosus.
- •16. Subjects who have a transplanted organ (with the exception of a corneal transplant >3 months prior to visit 1).
- •17. Subjects who have a known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location.
- •18. Subjects who have any malignancy within the previous 5 years (with the exception of basal cell carcinoma of the skin that has been treated with no evidence of recurrence).
- •19. Subjects who are unable or unwilling to und
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