Multicenter, Double-Blind, Randomized, 2-Arm, Parallel-Group, Equivalence Study Evaluating Efficacy and Safety Similarity of Mylan Adalimumab (MYL-1401A) Compared With Humira® in Subjects With Moderate-to-Severe Chronic Plaque Psoriasis

NCT02714322 Phase 3 COMPLETED

To assess the equivalence of MYL-1401A to Humira® with regards to efficacy in subjects with moderate-to-severe chronic plaque psoriasis

Details

Lead sponsor	Mylan Inc.
Phase	Phase 3
Status	COMPLETED
Enrolment	294
Start date	2015-06
Completion	2017-03

Conditions

• Psoriasis
• Arthritis, Psoriatic

Interventions

• MYL-1401A (Adalimumab)
• Humira® (Adalimumab)

Primary outcomes

• Percent improvement in PASI from Baseline — Baseline and Week 12

Countries

Bulgaria, Estonia, Hungary, Poland, Russia, Ukraine