NCT02745080

Efficacy of Secukinumab Compared to Adalimumab in Patients With Psoriatic Arthritis

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 853 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The total maximum study duration, including the screening period was up to 76 weeks. At Baseline, patients whose eligibility was confirmed were randomized to 1 of 2 groups (1:1): Group 1 (secukinumab 300 mg) or Group 2 (adalimumab 40 mg). In order to maintain the blind, both groups received 1 or 2 placebo s.c. injections to keep consistency in the number of injections at each dosing visit. Secukinumab (300 mg) was available in 2 x 1.0 mL pre-filled syringes (PFS) and adalimumab was available in 1 x 0.4 mL PFS. Placebo (1.0 and 0.5 mL PFS) was also available. Secukinumab 300 mg s.c injection (2 x 1 mL PFS) was administered at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks to Week 48. Adalimumab 40 mg (1 x 0.4 mL PFS) was administered at Baseline followed by dosing every 2 weeks until Week 50.

Conditions

• Psoriatic Arthritis

Interventions

Type	Name	Description
BIOLOGICAL	Secukinumab	Eligible subjects are randomized to one of two treatment arms in a 1:1 ratio
BIOLOGICAL	Adalimumab	Eligible subjects are randomized to one of two treatment arms in a 1:1 ratio

Timeline

• Start date: 2017-04-03
• Primary completion: 2019-12-30
• Completion: 2019-12-30
• First posted: 2016-04-20
• Last updated: 2021-01-27
• Results posted: 2021-01-27

Locations

156 sites across 26 countries: United States, Australia, 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

Regulatory

• FDA-regulated drug study