FUTURE 2A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate the Efficacy at 24 Weeks and to Assess the Long Term Efficacy, Safety and Tolerability up to 5 Years in Patients With Active Psoriatic Arthritis
Secukinumab (AIN457)
+ Placebo
Arthritis+10
+ Bone Diseases
+ Joint Diseases
Treatment Study
Summary
Study start date: April 14, 2013
Actual date on which the first participant was enrolled.At baseline (BSL), subjects whose eligibility was confirmed were randomized to one of the following four treatment groups. * 75 mg secukinumab * 150 mg secukinumab * 300 mg secukinumab * Placebo At Week 16, all subjects were classified as responders (≥ 20% improvement from BSL in both tender and swollen joint counts) or non-responders. Subjects who were randomized to a secukinumab treatment group at baseline were targeted to remain on the same dose for the entire trial. Subjects who were randomized to placebo at baseline were re-randomized at Week 16 as follows: Placebo non-responders received secukinumab 150 mg s.c. or 300 mg s.c. (1:1) every 4 weeks, starting after the efficacy assessments at Week 16. Placebo responders continued to receive placebo at Week 16 and Week 20 and received secukinumab 150 mg s.c. or 300 mg s.c. (1:1) every 4 weeks, starting after the efficacy assessments at Week 24. This was a double-blind, double-dummy, randomized treatment trial until week 52 analysis was completed and open label afterwards. An amendment to the study protocol (after all patients were in the trial for 2-3 years) introduced changes whereby patients previously treated with secukinumab 75 mg s.c. could change to receive 150 mg s.c. or 300 mg s.c., and patients previously treated with secukinumab 150 mg s.c. could change to receive 300 mg s.c., as deemed appropriate by the investigators.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.397 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.4 intervention groups are designated in this study
25% chance of being blinded to the placebo group
Treatment Groups
Group I
PlaceboGroup II
ExperimentalGroup III
ExperimentalGroup IV
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 76 locations
Novartis Investigative Site
Aventura, United StatesNovartis Investigative Site
Palm Harbor, United StatesNovartis Investigative Site
Sarasota, United States