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

Authors
Category Primary study
Registry of TrialsClinical Trials Peruvian Registry
Year 2012
INTERVENTION: 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 RANDOMIZARÁN FITNESS ONE OF THREE TREATMENT GROUPS: .GROUP 1: SECUKINUMAB i.v SECUKINUMAB i.v (10 mg / kg) IN BSL, WEEK 2 AND 4 AND THEN SECUKINUMAB 75 mg sc BEGINNING IN THE WEEK 8 E INJECTED EVERY 4 WEEKS .GROUP 2: SECUKINUMAB i.v (10 mg / kg) IN BSL, WEEK 2 AND 4 AND THEN SECUKINUMAB 150 mg sc BEGINNING IN THE WEEK 8 E INJECTED EVERY 4 WEEKS .GROUP 3: PLACEBO i.v in BSL, WEEK 2, 4, THEN PLACEBO s.c WEEK BEGINNING AT 8 AND 12. PATIENTS WILL BE STRATIFIED THE UNDER INCOMPLETE RESPONSE STATUS (IR) to TNF INHIBITORS WITH OR WITHOUT PRETREATMENT TNRα 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 180 PATIENTS WITH A TNF INHIBITORS AND 420 PATIENTS TREATED WITH PRIOR TNFα 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. CONDITION: PRIMARY OUTCOME: Proportion of patients achieving ACR20 response criteria at week 24 on secukinumab 75 or 150 mg vs. placebo, in the subgroup of subjects who are TNFα inhibitor naïve; NAME OF THE RESULT: Proportion of patients achieving American College of Rheumatology 20% response criteria on secukinumab 75 or 150 mg vs. placebo, in the subgroup of patients who are TNFα inhibitor naïve; USED MEASURING METHOD :Analyzed via logistic regression with treatment as a factor and weight as a covariate.; PERIOD OF TIME WHERE THE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Baseline to Week 24. SECONDARY OUTCOME: Change from baseline in Health Assessment Questionnaire‐Disability Index (HAQ‐DI) at week 24 on secukinumab 75 or 150 mg vs. placebo, in the subgroup of subjects who are TNFα inhibitor naïve. ; NAME OF THE RESULT: Change from baseline in Health Assessment Questionnaire‐Disability Index (HAQ‐DI) at week 24 on secukinumab 75 or 150 mg vs. placebo, in the subgroup of subjects who are TNFα inhibitor naïve. ; USED MEASURING METHOD :ANCOVA model with treatment regimen, weight, and baseline HAQ‐DI as effects. ; PERIOD OF TIME WHERE THE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE SECONDARY RESULT: Baseline to Week 24. 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 6. PATIENTS SHOULD HAVE RECEIVED NSAID PSA FOR AT LEAST 4 WEEKS BEFORE THE INADEQUATE CONTROL 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.
Epistemonikos ID: 70b0d5fba934799c7d3ba218ae86dd0abc4742a2
First added on: Aug 22, 2024