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AIN457 Regimen Finding Extension Study in Patients With Moderate to Severe Psoriasis - NCT01132612-19104(Clinical Trial 651622)



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City:  Philadelphia
State:  
PA
Zip Code: 19104
Conditions: Plaque-Type Psoriasis
Purpose: The purpose of this study is to provide long term clinical data for the compound for the treatment of the indication of moderate to severe chronic plaque-type psoriasis.
Study summary:
Criteria: Inclusion Criteria: - Patients who completed the core study CAIN457A2211. A patient is defined as having completed the core study if he/she completed the study up to and including visit 13 (F4) of the core study - Patients must be able to understand and communicate with the investigator and comply with the requirement of the study and must given written, signed and dated informed consent before any study assessment is performed. - Patients must be expected to benefit from the ongoing treatment with AIN457, as assessed by the patient and investigator - Male patients must consent to practice reliable contraception during the study and for 16 weeks after the last dose of study drug administration Exclusion Criteria: - Patients who experience a second consecutive full relapse at visit 13 ( week F4) of the core study CAIN457A2211 - Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until termination of gestation, confirmed by a positive hCG laboratory test (> 5mlU/mL) - Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, UNLESS they are: - women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner - women whose partners have been sterilized by vasectomy or other means - using a highly effective method of birth control (i.e. one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, condoms (by the partner) and some intrauterine devices (IUDs); Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) are not acceptable Other protocol-defined inclusion/exclusion criteria may apply
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Data Source: ClinicalTrials.gov
Date Processed: January 6, 2011
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