Study to Demonstrate Equivalent Efficacy and to Compare Safety of Biosimilar Adalimumab (GP2017) and Humira

Conditions

• Plaque Type Psoriasis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• GP2017 Adalimumab — DRUG
• Humira ® Adalimumab — DRUG

Study Details

The aim of the study is to demonstrate equivalent efficacy and similarity in the safety profile of GP2017 and Humira® in patients with moderate to severe chronic plaque-type psoriasis.

Key Dates

Start date

Dec 31, 2013

Status verified

Apr 2017

Primary completion

Jul 31, 2015

Completion

Feb 29, 2016

Study Design

Enrollment

465 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: GP2017 Adalimumab
  Study arm with intervention being studied in the protocol. Adalimumab Solution for subcutaneous injection with an initial dose of 80 mg s.c. in Week 0, followed by 40 mg s.c. eow, starting at Week 1 and ending at Week 51.
• Active Comparator: Humira ® Adalimumab
  Humira® Adalimumab as a subcutaneous injection with an initial dose of 80 mg s.c. in Week 0, followed by 40 mg s.c. eow, starting at Week 1 and ending at Week 51.

Primary Outcome Measure

PASI 75 Response Rate at Week 16 - GP2017 Adalimumab vs Humira ® Adalimumab [ Time Frame: At Week 16 only ]

Locations (69)

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