Study to demonstrate the efficacy, safety and tolerability of intravenous secukinumab up to 52 weeks in subjects with active Psoriatic Arthritis

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2020
INTERVENTION: Intervention1: Secukinumab 6mg/kg i.v. followed by secukinumab 3mg/kg i.v: Approximately 190 patients with psoriatic arthritis; these patients will receive Secukinumab 6mg/kg i.v. at BSL, followed by the administration of secukinumab 3mg/kg i.v every four weeks starting at Week 4. Control Intervention1: Placebo followed by secukinumab 3mg/kg: Approximately 190 patirnts with Psoriatic arthritis; these patients will receive i.v. placebo at BSL and at Weeks 4, 8 and 12, followed by the administration of secukinumab 3mg/kg i.v. every four weeks starting at week 16 CONDITION: Health Condition 1: M138‐ Other specified arthritis PRIMARY OUTCOME: To demonstrate that the efficacy of i.v. of secukinumab at week 16 is superior to placebo in subjects with active psoriatic arthritis (PsA) based on the proportion of patients achieving an American College of Rheumatology 50 (ACR50) response.Timepoint: To demonstrate that the efficacy of i.v. of secukinumab at week 16 is superior to placebo in subjects with active psoriatic arthritis (PsA) based on the proportion of patients achieving an American College of Rheumatology 50 (ACR50) response. SECONDARY OUTCOME: The efficacy of i.v. secukinumab at week 16 is superior to placebo based on the proportion of patients achieving Minimal Disease Activity MDA 5/7.Timepoint: Week 16 The efficacy of i.v. secukinumab at week 16 is superior to placebo based on the proportion of subjects achieving an ACR20 response.Timepoint: Week 16 The improvement from baseline on i.v. secukinumab is superior to placebo for the PASDAS.Timepoint: Week 16 INCLUSION CRITERIA: 1. Diagnosis of PsA classified by CASPAR criteria and with symptoms for at leasr 6 months with moderate to severe PsA who must have at BSL more than or equal to 3 tender joints out of 78 and more than 3 swollen joints out of 76 (dactylitis of a digit counts as one joint each) 2. Rheumatoid factor (RF)and anti‐cyclic citrullinated peptide (anti‐CCP) antibodies negative at screening. 3. Subjects with PsA should have taken NSAIDs for at least 4 weeks prior to randomization with inadequate control of symptoms or at least one dose if stopped due to intolerance to NSAIDs. 4. Subjects who are regularly taking NSAIDs as part of their PsA therapy are required to be on stable dose for at least 2 weeks before study randomization and should remain on a stable dose up to Week 16.
Epistemonikos ID: b7e570349f9514b180e004783370957f077b0946
First added on: Feb 15, 2022