None listed
Conditions
Interventions
WILL USE A PERIOD OF SELECTION OF UP TO 4 WEEKS BEFORE THE FITNESS ASSESSMENT RANDOMIZATION FOLLOWED BY A PERIOD OF TWO YEARS TREATMENT. IN THE INITIAL VISIT (BSL) PATIENTS WITH CONFIRMED SE RANDOMIZA
INHIBITORS. EXPECTED TO 30% OF PATIENTS PRESENTING IMPROPER RESPONSE TNF INHIBITORS TO ENSURE PATIENT REPRESENTATIVE POPULATION ASSESSMENT OF EFFICACY AND SAFETY. THEREFORE EXPECTED RANDOMIZE GO ABOUT
INHIBITORS.
IN WEEK 16 (VISIT 8), SHALL BE CLASSIFIED AS PATIENTS WITH ANSWER (≥
20% IMPROVEMENT FROM HOME BOTH COUNTS AS SENSITIVE JOINTS INFLAMED) OR NO ANSWER.
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Countries
Argentina, Australia, Belgium, Bulgaria, Canada, Colombia, Czech Republic, Germany, Israel, Italy, Philippines, Poland, Russian Federation, Singapore, Slovakia, Taiwan, Turkey, United Kindgdom, United States
Contacts
Public ContactAlexandra Lopez
NOVARTIS BIOSCIENCES PERU S.A.
Outcome results
None listed