CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 853 enrolled
Drug / intervention
Secukinumab +1 morebiological
Likely dose
Not stated in record
Key inclusion· 5
  • Diagnosis of PsA classified by CASPAR criteria
  • Rheumatoid factor and anti-CCP antibodies negative
  • Active plaque psoriasis with at least one psoriatic plaque ≥2 cm diameter, or nail changes consistent with psoriasis, or documented history of plaque psoriasis
  • Inadequate control of symptoms with NSAIDs
Key exclusion· 6
  • Pregnant or nursing women
  • Evidence of ongoing infectious or malignant process
  • Previous exposure to any biologic drug for PsA or psoriasis
  • Taking high potency opioid analgesics

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02745080
NCT02745080Phase 3Completed

A Randomized, Double-blind, Active Control, Multicenter Study to Evaluate the Efficacy at Week 52 of Secukinumab Monotherapy Compared With Adalimumab Monotherapy in Patients With Active Psoriatic Arthritis

Novartis Pharmaceuticals·interventional·Posted Apr 20, 2016·Updated Jan 27, 2021

In Brief

A Phase 3 clinical trial evaluating Secukinumab and Adalimumab for Psoriatic Arthritis. Completed, enrolled 853 participants across 156 sites in 26 countries.

Detailed Summary

This was a randomized, double-blind, active controlled, multicenter, parallel-group study evaluating secukinumab monotherapy and adalimumab monotherapy in approximately 850 patients with active psoriatic arthritis (PsA) who are naïve to biologic therapy and are intolerant or having inadequate response to conventional disease modifying anti-rheumatic drugs (also known as non-biologic DMARDs).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Bulgaria, Canada, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, India, Israel, Italy, Latvia, Lithuania, Netherlands, Poland, Portugal, Russia, Slovakia, South Korea, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedApr 20, 2016
Enrollment StartApr 3, 2017
Primary CompletionDec 30, 2019
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 10.2 years ago

Interventions

Secukinumabbiological

Eligible subjects are randomized to one of two treatment arms in a 1:1 ratio

Adalimumabbiological

Eligible subjects are randomized to one of two treatment arms in a 1:1 ratio