A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF SECUKINUMAB TO DEMOSTRATE THE EFFICACY AT 24 WEEKS AND TO ASSESS THE SAFETY, TOLERABILITY AND LONG TERM EFFICACY UP TO 2 YEAR IN PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS

OVARTIS BIOSCIENSES PERU S.A.,0 个研究点目标入组 0 人开始时间: 2012年1月31日最近更新: 2023年9月4日

研究概览

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•1. PATIENT MUST BE ABLE TO UNDERSTAND AND COMMUNICATE WITH THE INVESTIGATOR AND BE ABLE TO MEET THE REQUIREMENTS OF THE STUDY AND INFORMED CONSENT MUST PROVIDE A WRITTEN, SIGNED AND DATED BEFORE ANY EVALUATION STUDY.
•2. PATIENTS NO MEN OR WOMEN IN PREGNANT OR BREASTFEEDING OF AT LEAST 18 YEARS OF AGE.
•3. PSA DIAGNOSTIC CRITERIA CLASSIFIED BY CASPAR (SEE APPENDIX 2) AND SYMPTOMS FOR AT LEAST 6 MONTHS WITH PSA MODERATE TO SEVERE AND INITIAL FORM SHOULD BE SENSITIVE 3 JOINTS ≥ 78 SWOLLEN JOINTS AND ≥ 3 OF 76 (ONE DACTYLITIS IS RECORDED AS A FINGER JOINT)
•4. RF AND NEGATIVE ANTI CCP
•5. DIAGNOSIS OF PSORIASIS IN ACTIVE PLATES, WITH AT LEAST ONE OF PLATE PSORIATIC ≥ 2 CM IN DIAMETER (BUT NOT AS AREAS UNDERARMS INTERTRIGO, BREAST OR CHEST BETWEEN THE CREASE INGUINAL) OR NAIL CHANGES CONSISTENT WITH PSORIASIS OR BACKGROUND DOCUMENTED IN PLATES.
•6. PATIENTS SHOULD HAVE RECEIVED NSAID PSA FOR AT LEAST 4 WEEKS BEFORE THE INADEQUATE CONTROL RANDOMISATION SYMPTOMS OR INTOLERANCE THEREOF.

•1. PATIENTS WHO TAKE HIGH POWER OPIOID ANALGESICS (EG. METHADONE, MORPHINE HYDROMORPHONE O)
•2. PATIENTS WHO EVER RECEIVED EXCEPT IMMUNOMODULATING BIOLOGICAL AGENTS TARGETING THE TNFα, EXPERIMENTAL OR APPROVED
•3. ARE PREVIOUSLY TREATED PATIENTS WITH MORE THAN 3 DIFFERENT INHIBITORS TNFα (EXPERIMENTAL OR APPROVED)
•4. PRE-EXPOSURE SECUKINUMAB BIOLOGICAL OR ANY OTHER MEDICINES THAT IS AIMED DIRECTLY AGAINST OR RECEIVER IL 17 IL 17
•5. ANY USE OF MEDICATION AND / OR EXPERIMENTAL DEVICE WITHIN 4 WEEKS OF RANDOMIZATION O 5 LIVES AVERAGE EXPERIMENTAL MEDICINE, WHICHEVER IS GREATER.
•6. CURRENT USE OF TREATMENTS / MEDICATIONS FOR PSORIASIS PROHIBITED (EG. TOPICAL CORTICOSTEROIDS, UV TREATMENT) IN RANDOMIZATION. MUST OBSERVE THE FOLLOWING DRUG REST PERIODS:
•A. RETINOIDS ORAL OR TOPICAL 4 WEEKS
•B. PHOTOCHEMOTHERAPY (EG. PUVA) 4 WEEKS
•C. PHOTOTHERAPY (UVA or UVB) 2 WEEKS

发起方

OVARTIS BIOSCIENSES PERU S.A.,