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

Information source: Sandoz
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Plaque Type Psoriasis

Intervention: GP2017 Adalimumab (Drug); Humira ® Adalimumab (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Sandoz

Summary

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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: The primary outcome measure is the PASI 75 response rate

Secondary outcome:

PASI response rates

Change from baseline in IGA

Patient's health related quality of life (HRQoL)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

UMHAT Dr. Georgi Stranski, EAD, Pleven, Bulgaria

Center for Skin and Venereal Diseases EOOD Sofia, Sofia, Bulgaria

UMHAT "Alexandrovska", EAD, Sofia, Bulgaria

Diagnostic-consulting center 3-Varna EOOD, Varna, Bulgaria

Hopital de l'Archet 2, Nice Cedex 3, France

H├┤pital Charles Nicolle, Rouen, France

Kozne oddelenie,Nemocnica Kosice-Saca a.s.,1. sukromna nemoc, Kosice-Saca, Slovakia

Pedi-Derma s.r.o., Dermatovenerologicka ambulancia, Kosice, Slovakia

SANARA s.r.o, Dermatovenerologicka Ambulancia, Svidnik 08901, Slovakia

SANARE s.r.o., Svidnik, Slovakia

Total Skin & Beauty Dermatology Center, Birmingham, Alabama, United States

Alliance Dermatology & MOHS Center, PC, Phoenix, Arizona 85032, United States

Burke Pharmaceutical Research, Hot Springs, Arkansas, United States

Anaheim Clinical Trials, Anaheim, California, United States

Bakersfield Dermatology and Skin Cancer Medical Group, Bakersfield, California, United States

Wallace Medical Group, Beverly Hills, California 90211, United States

California Dermatology & Clinical Research Institute, Encinitas, California 92024, United States

Dr. Howard Sofen, Los Angeles, California, United States

Southern California Permanente Medical Group, Los Angeles, California, United States

Palmtree Clinical Research, Rancho Mirage, California 92270, United States

Medical Center For Clinical Research, San Diego, California, United States

Therapeutics Clinical Research, San Diego, California, United States

Clinical Science Institute, Santa Monica, California 90404, United States

Ventura Clinical Trials, Ventura, California 93003, United States

Horizons Clinical Research Center, LLC, Denver, Colorado 80220, United States

Savin Dermatology Center, P.C., New Haven, Connecticut, United States

Florida Academic Dermatology Center, Coral Gables, Florida, United States

Florida Medical Center & Research Inc, Miami, Florida, United States

Renstar Medical Research, Ocala, Florida 34471, United States

Psoriasis Treatment Center of South Florida, Pembroke Pines, Florida 33028, United States

McIlwain Medical Group, PA, Tampa, Florida 33613, United States

MedPhase, Inc., Newnan, Georgia 30263, United States

Pharmaceutical Research Organization, Rigby, Idaho, United States

Dundee Derm., West Dundee, Illinois, United States

Dawes Fretzin Clinical Research Group, LLC, Indianapolis, Indiana 46256, United States

The Dermatology Center, PSC, New Albany, Indiana 47150, United States

The Indiana Clinical Trials Center, Plainfield, Indiana, United States

Dermatology Specialists Research, LLC, Louisville, Kentucky 40202, United States

DermResearch, PLLC, Louisville, Kentucky, United States

Pedia Research, LLC, Owensboro, Kentucky, United States

Medical Development Centers, LLC, Baton Rouge, Louisiana 70808, United States

Dermat. & Adv. Aesthetics, Lake Charles, Louisiana, United States

Clinical Trials of America, Inc., Monroe, Louisiana, United States

Bay State Clinical Trials, Inc., Watertown, Massachusetts, United States

Great Lakes Research Group, Inc., Bay City, Michigan 48706, United States

Somerset Skin Centre, Troy, Michigan, United States

Associated Skin Care Specs, Fridley, Minnesota, United States

MediSearch Clinical Trials, St. Joseph, Missouri, United States

Central Dermatology, St. Louis, Missouri 63117, United States

The Clinical Research Center, L.L.C., St. Louis, Missouri, United States

J. Woodson Dermatology & Associates, Henderson, Nevada, United States

Las Vegas Skin and Cancer Clinic, Las Vegas, Nevada 89128, United States

Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire 03756, United States

Buffalo Medical Group, P.C., Buffalo, New York, United States

Forest Hills Dermatology Group, Forest Hills, New York 11375, United States

New York University Medical, Lake Success, New York 11041, United States

DermResearch Center of New York, Stony Brook, New York, United States

PMG Research of Charlotte, LLC, Charlotte, North Carolina, United States

Wake Research Associates, LLC, Raleigh, North Carolina 27612, United States

Wilmington Dermatology Center, Wilmington, North Carolina 28403, United States

PMG Research of Winston-Salem, LLC, Winston-Salem, North Carolina, United States

Ohio State University Clinical Trials Management Office, Columbus, Ohio, United States

Lynn Health Science Institute, Oklahoma City, Oklahoma 73112, United States

Corvallis Clinic PC, Corvallis, Oregon 97330, United States

Oregon Dermatology and Research Center, Portland, Oregon 97210, United States

Oregon Medical Research Center, P.C., Portland, Oregon 97223, United States

University of Pittsburgh Medical Center Health System, Pittsburgh, Pennsylvania 15213, United States

Clinical Partners, LLC, Johnston, Rhode Island, United States

Radiant Research, Inc., Greer, South Carolina, United States

Health Concepts, Rapid City, South Dakota, United States

PMG Research of Bristol, LLC, Bristol, Tennessee 37620, United States

Austin Dermatology Associates, Austin, Texas 78705, United States

Menter Dermatology Research Institute, Dallas, Texas, United States

Modern Research Associates, Dallas, Texas, United States

Stephen Miller MD, San Antonio, Texas 78249, United States

Center for Clinical Studies, Webster, Texas, United States

Advanced Research Institute, Ogden, Utah, United States

Premier Clinical Research, Spokane, Washington, United States

Mountain State Clinical Research, Clarksburg, West Virginia, United States

Additional Information

Starting date: December 2013
Last updated: February 25, 2015

Page last updated: August 23, 2015

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