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



Status:Active, not recruiting
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:6/11/2016
Start Date:December 2013
End Date:July 2016

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A Randomized, Double-blind, Multicenter Study to Demonstrate Equivalent Efficacy and to Compare Safety and Immunogenicity of a Biosimilar Adalimumab (GP2017) and Humira® in Patients With Moderate to Severe Chronic Plaque-type Psoriasis

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.


Inclusion Criteria:

- Men or women at least 18 years of age at time of screening

- Chronic plaque-type psoriasis diagnosed for at least 6 months before randomization

- Moderate to severe psoriasis as defined at baseline by:

- PASI score of 12 or greater

- Investigator´s Global Assessment score of 3 or greater (based on a scale of 0 -
4) and,

- Body Surface Area affected by plaque-type psoriasis of 10% or greater

- Chronic plaque-type psoriasis patients who have previously received phototherapy or
systemic psoriasis therapy at least once or who are candidates for such therapies in
the opinion of the investigator.

Exclusion Criteria:

- Forms of psoriasis other than chronic plaque-type

- Drug-induced psoriasis

- Ongoing use of prohibited psoriasis treatments

- Previous exposure to adalimumab

- Active ongoing inflammatory diseases other than psoriasis that might confound the
evaluation of the benefit of treatment with adalimumab

Other In-/Exclusion criteria may apply
We found this trial at
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1085 N Harbor Blvd
Anaheim, California 92801
(714) 774-7777
Anaheim Clinical Trials, LLC Anaheim Clinical Trials (ACT) is a research center of excellence for...
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4495 Hale Parkway
Denver, Colorado 80220
303-399-4067
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104 SE 1st Avenue
Ocala, Florida 34471
352-629-5800
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Buffalo, New York 14221
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Charlotte, North Carolina 28209
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
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Louisville, Kentucky 40217
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286 Westward Drive
Miami, Florida 33142
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Ogden, Utah 84405
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3555 NW 58th St # 800
Oklahoma City, Oklahoma 73112
(405) 447-8839
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3100 Duraleigh Rd
Raleigh, North Carolina 27612
(919) 781-2514
Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
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Rancho Mirage, California 92270
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1901 S Hawthorne Rd #306
Winston-Salem, North Carolina 27103
(336) 768-8062
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