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 |
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.
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
70
sites
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Anaheim Clinical Trials, LLC Anaheim Clinical Trials (ACT) is a research center of excellence for...
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Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Lynn Health Science Institute Our mission is to provide clinical trials research and health services...
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Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
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1901 S Hawthorne Rd #306
Winston-Salem, North Carolina 27103
Winston-Salem, North Carolina 27103
(336) 768-8062
PMG Research of Winston-Salem PMG Research of Winston-Salem, founded in 1979, occupies a 10,000 square...
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