Study to Demonstrate Equivalent Efficacy and to Compare Safety of Biosimilar Adalimumab (GP2017) and Humira
- Conditions
- Plaque Type Psoriasis
- Interventions
- Drug: GP2017 Adalimumab
- Registration Number
- NCT02016105
- Lead Sponsor
- Sandoz
- Brief 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.
- Detailed Description
The aim of this study (Treatment Period 1) was to demonstrate equivalent efficacy, primarily based on the PASI75 response rate at Week 16, and similar safety of the proposed biosimilar GP2017 and Humira in patients with moderate to severe chronic plaque-type psoriasis at the end of Treatment Period 1, after 17 weeks of study treatment.
The subsequent Treatment Period 2 (Week 17 to Week 35) and the Extension Period (Week 35 to Week 51) were performed to evaluate long-term effects, including immunogenicity (i.e. ADAs), and the effects of repeated switching between GP2017 and Humira.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 465
-
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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description GP2017 Adalimumab 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. Humira ® Adalimumab 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 Measures
Name Time Method PASI 75 Response Rate at Week 16 - GP2017 Adalimumab vs Humira ® Adalimumab At Week 16 only The primary variable was the PASI75 response rate at Week 16, defined as the proportion of patients achieving a reduction of 75% or more of the PASI score at Week 16 compared with baseline.
- Secondary Outcome Measures
Name Time Method Mean Percent Change From Baseline in PASI Score up to Week 16 (MMRM) Baseline to Week 16 The key secondary efficacy variable was the percentage change from baseline in PASI score at each visit up to Week 16.
PASI 50, PASI 75, PASI 90 and PASI 100 Response Rates At Week 17 only Proportion of patients achieving PASI 50, 75, 90 and 100 at Week 17 (end of Treatment Period 1)
Mean ATE of Percent Change From Baseline in PASI Score up to Week 16 (ANCOVA) Baseline to Week 16 The key secondary efficacy variable was the average treatment effect (ATE) which is the weighted average of % change from baseline in PASI scores between Week 1 and Week 16 (weights based on the time interval between two consecutive visits).
DLQI At Week 51 only Proportion of patients reporting a DLQI of 0 or 1 (no effect at all on patient's life)
PASI 50, PASI75, PASI 90 and PASI100 Response Rates At Week 51 only Proportion of Patients Achieving PASI 50, 75, 90 and 100 at Week 51 (Entire Study)
ADA Formation Against GP2017 Adalimumab and Humira® Adalimumab From Randomization Until Week 51 At Week 51 only Proportion of patients with at least one confirmed positive anti-drug antibodies (ADA) response to adalimumab from Randomization to Week 51.
Patients with ADA positive results at baseline were excluded from subsequent results.IGA Response Rate At Week 51 only Proportion of patients achieving a score of 0 ("clear") or 1 ("almost clear") or improved by at least 2 points of the IGA scale compared to baseline at Week 51
ADA Formation Against GP2017 Adalimumab and Humira® Adalimumab From Randomization Until Week 17 At Week 17 only Proportion of patients with at least one confirmed positive anti-drug antibodies (ADA) response to adalimumab from Randomization to Week 17.
Patients with ADA positive results at baseline were excluded from subsequent results.
Trial Locations
- Locations (79)
Palmtree Clinical Research
🇺🇸Rancho Mirage, California, United States
Menter Dermatology Research Institute
🇺🇸Dallas, Texas, United States
Medical Development Centers, LLC
🇺🇸Baton Rouge, Louisiana, United States
MediSearch Clinical Trials
🇺🇸Saint Joseph, Missouri, United States
Modern Research Associates
🇺🇸Dallas, Texas, United States
Dr. Howard Sofen
🇺🇸Los Angeles, California, United States
Southern California Permanente Medical Group
🇺🇸Los Angeles, California, United States
Pedi-Derma s.r.o., Dermatovenerologicka ambulancia
🇸🇰Kosice, Slovakia
SANARE s.r.o.
🇸🇰Svidnik, Slovakia
Florida Medical Center & Research Inc
🇺🇸Miami, Florida, United States
Dawes Fretzin Clinical Research Group, LLC
🇺🇸Indianapolis, Indiana, United States
Therapeutics Clinical Research
🇺🇸San Diego, California, United States
Stephen Miller MD
🇺🇸San Antonio, Texas, United States
Wallace Medical Group
🇺🇸Beverly Hills, California, United States
Florida Academic Dermatology Center
🇺🇸Coral Gables, Florida, United States
Clinical Trials of America, Inc.
🇺🇸Monroe, Louisiana, United States
Associated Skin Care Specs
🇺🇸Fridley, Minnesota, United States
Clinical Science Institute
🇺🇸Santa Monica, California, United States
Corvallis Clinic PC
🇺🇸Corvallis, Oregon, United States
Medical Center For Clinical Research
🇺🇸San Diego, California, United States
Austin Dermatology Associates
🇺🇸Austin, Texas, United States
Ventura Clinical Trials
🇺🇸Ventura, California, United States
MedPhase, Inc.
🇺🇸Newnan, Georgia, United States
Psoriasis Treatment Center of South Florida
🇺🇸Pembroke Pines, Florida, United States
Las Vegas Skin and Cancer Clinic
🇺🇸Las Vegas, Nevada, United States
Center for Clinical Studies
🇺🇸Webster, Texas, United States
Wake Research Associates, LLC
🇺🇸Raleigh, North Carolina, United States
Center for Skin and Venereal Diseases EOOD Sofia
🇧🇬Sofia, Bulgaria
SANARE s.r.o. Dermatovenerologická ambulancia
🇸🇰Svidník, Slovakia
Dermat. & Adv. Aesthetics
🇺🇸Lake Charles, Louisiana, United States
Bay State Clinical Trials, Inc.
🇺🇸Watertown, Massachusetts, United States
PMG Research of Bristol, LLC
🇺🇸Bristol, Tennessee, United States
Pedia Research, LLC
🇺🇸Owensboro, Kentucky, United States
PMG Research of Charlotte, LLC
🇺🇸Charlotte, North Carolina, United States
Kozne oddelenie,Nemocnica Kosice-Saca a.s.,1. sukromna nemoc
🇸🇰Kosice-Saca, Slovakia
Hôpital Charles Nicolle
🇫🇷Rouen, France
Hopital de l'Archet 2
🇫🇷Nice Cedex 3, France
Diagnostic-consulting center 3-Varna EOOD
🇧🇬Varna, Bulgaria
Central Dermatology
🇺🇸Saint Louis, Missouri, United States
New York University Medical
🇺🇸Lake Success, New York, United States
DermResearch Center of New York
🇺🇸Stony Brook, New York, United States
Wilmington Dermatology Center
🇺🇸Wilmington, North Carolina, 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
California Dermatology & Clinical Research Institute
🇺🇸Encinitas, California, United States
Renstar Medical Research
🇺🇸Ocala, Florida, United States
The Dermatology Center, PSC
🇺🇸New Albany, Indiana, United States
Pharmaceutical Research Organization
🇺🇸Rigby, Idaho, United States
Dundee Derm.
🇺🇸West Dundee, Illinois, United States
The Indiana Clinical Trials Center
🇺🇸Plainfield, Indiana, United States
Somerset Skin Centre
🇺🇸Troy, Michigan, United States
The Clinical Research Center, L.L.C.
🇺🇸Saint Louis, Missouri, United States
Forest Hills Dermatology Group
🇺🇸Forest Hills, New York, United States
Ohio State University Clinical Trials Management Office
🇺🇸Columbus, Ohio, United States
University of Pittsburgh Medical Center Health System
🇺🇸Pittsburgh, Pennsylvania, United States
UMHAT Dr. Georgi Stranski, EAD
🇧🇬Pleven, Bulgaria
Mountain State Clinical Research
🇺🇸Clarksburg, West Virginia, United States
UMHAT "Alexandrovska", EAD
🇧🇬Sofia, Bulgaria
Advanced Research Institute
🇺🇸Ogden, Utah, United States
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
J. Woodson Dermatology & Associates
🇺🇸Henderson, Nevada, United States
Clinical Partners, LLC
🇺🇸Johnston, Rhode Island, United States
Radiant Research, Inc.
🇺🇸Greer, South Carolina, United States
McIlwain Medical Group, PA
🇺🇸Tampa, Florida, United States
Dermatology Specialists Research, LLC
🇺🇸Louisville, Kentucky, United States
DermResearch, PLLC
🇺🇸Louisville, Kentucky, United States
Total Skin & Beauty Dermatology Center
🇺🇸Birmingham, Alabama, United States
Alliance Dermatology & MOHS Center, PC
🇺🇸Phoenix, Arizona, United States
Savin Dermatology Center, P.C.
🇺🇸New Haven, Connecticut, United States
Horizons Clinical Research Center, LLC
🇺🇸Denver, Colorado, United States
PMG Research of Winston-Salem, LLC
🇺🇸Winston-Salem, North Carolina, United States
Lynn Health Science Institute
🇺🇸Oklahoma City, Oklahoma, United States
Oregon Dermatology and Research Center
🇺🇸Portland, Oregon, United States
Oregon Medical Research Center, P.C.
🇺🇸Portland, Oregon, United States
Great Lakes Research Group, Inc.
🇺🇸Bay City, Michigan, United States
Buffalo Medical Group, P.C.
🇺🇸Buffalo, New York, United States
Health Concepts
🇺🇸Rapid City, South Dakota, United States
Premier Clinical Research
🇺🇸Spokane, Washington, United States