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

• Conditions: Patients with moderate to severe psoriasi.; MedDRA version: 9.1Level: LLTClassification code 10037153Term: Psoriasis

• Registration Number: EUCTR2007-000535-26-IT
• Lead Sponsor: SCHERING-PLOUGH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-06
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

The subject must meet ALL of the criteria listed below for entry: 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 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 PASI75 or presents BSA >=10 at Screening visit (V1) after 24 weeks of etanercept treatment. 4. Subjects who have 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 and avoid use of tanning booths or other ultraviolet light sources during the study. 6. Subjects are considered eligible according to the following tuberculosis (TB) screening 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. Within 1 month prior to the first administration of study medication, either have negative diagnostic TB test results (defined as 2 negative tuberculin skin tests) OR have a newly identified positive diagnostic TB test result (defined as at least 1 positive tuberculin skin tests) during screening in which active TB has been ruled out and for which appropriate treatment for latent TB has been initiated either prior to or simultaneously with the first administration of study medication; 8. Subjects must have had a chest x-ray (posterior-anterior and lateral) within 3 months prior to Screening with no evidence of malignancy, infection, fibrosis, or current or old active TB. 9. Subjects? Screening clinical laboratory tests (CBC, blood chemistry, and urine analysis) 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 g. Total bilirubin <=1.5 x upper limit of normal 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 give written informed consent and be able to adhere to dose and visit schedules. 11. Women of childbearing potential and all men must be using adequate birth control measures (eg, abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, or surgical sterilization) 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 Screening and a negative urin

Exclusion Criteria

The subject will be excluded from entry if ANY of the criteria listed below are met: 1. Subjects who achieve PASI75 after 24 weeks of etanercept treatment. Subjects who have BSA < 10 after 24 weeks of etanercept treatment. 2. Subjects who have current drug-induced psoriasis (eg, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium). 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 Baseline (see Section 6.2): a. any live virus or bacterial vaccinations received within 3 months. b. any systemic medications/treatments that could affect psoriasis or PASI evaluations within 4 weeks. c. any systemic immunosuppressants within 4 weeks. d. lithium within 4 weeks.Any topical medications/treatments that could affect psoriasis or PASI evaluations within 2 weeks. The only allowed topical treatments for psoriasis are shampoos (containing salicylic acid only) and topical moisturizers. Subjects should not use these topical agents during the morning prior to a study visit. Non-medicated shampoos may be used on the morning of a visit. 6. Subjects who have a concomitant diagnosis of congestive heart failure (CHF), including medically-controlled asymptomatic subjects. 7. Subjects who have a history of chronic or recurrent infectious disease, including but not limited to, chronic renal infection, chronic chest infection (eg, bronchiectasis), recurrent urinary tract infection (recurrent pyelonephritis or chronic nonremitting cystitis), or open, draining, or infected skin wounds or ulcers. 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 an infection during the 2 months prior to Screening. 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 Screening. 10. Subjects who have or have had a Herpes zoster infection within 2 months prior to Screening. 11. Subjects who are known to be infected with human immunodeficiency virus, hepatitis B, or hepatitis C. 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 Screening). 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 known malignancy or have a history of

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: Secondary Objectives: To assess the efficacy of infliximab through the following parameters: PASI (Psoriasis Area and Severity Index) 50, 75,90 and 100 BSA (Body Surface Area Affected) SAPASI (Self-Administered PASI) VAS (visual analog scale) to assess itch intensity To assess the QOL (quality of life) through SKINDEX29 and DLQI. To evaluate the tolerance and safety of infliximab.;Main Objective: The primary objective of this study is to assess the efficacy of infliximab therapy (5 mg/kg by body weight), evaluated through PASI 75 (defined as the proportion of subjects achieving a >75% improvement) at week 10.;Primary end point(s): The primary efficacy endpoint for this study is the PASI 75 response rate at Week 10 (proportion of subjects achieving a ≥75% improvement in PASI from Baseline to Week 10).