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

Primary Purpose

Plaque Type Psoriasis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
GP2017 Adalimumab
Humira ® Adalimumab
Sponsored by
Sandoz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plaque Type Psoriasis focused on measuring plaque type psoriasis, equivalent efficacy, safety and immunogenicity, GP2017, Humira®

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Total Skin & Beauty Dermatology Center
  • Alliance Dermatology & MOHS Center, PC
  • Burke Pharmaceutical Research
  • Anaheim Clinical Trials
  • Bakersfield Dermatology and Skin Cancer Medical Group
  • Wallace Medical Group
  • California Dermatology & Clinical Research Institute
  • Dr. Howard Sofen
  • Southern California Permanente Medical Group
  • Palmtree Clinical Research
  • Medical Center For Clinical Research
  • Therapeutics Clinical Research
  • Clinical Science Institute
  • Ventura Clinical Trials
  • Horizons Clinical Research Center, LLC
  • Savin Dermatology Center, P.C.
  • Florida Academic Dermatology Center
  • Florida Medical Center & Research Inc
  • Renstar Medical Research
  • Psoriasis Treatment Center of South Florida
  • McIlwain Medical Group, PA
  • MedPhase, Inc.
  • Pharmaceutical Research Organization
  • Dundee Derm.
  • Dawes Fretzin Clinical Research Group, LLC
  • The Dermatology Center, PSC
  • The Indiana Clinical Trials Center
  • Dermatology Specialists Research, LLC
  • DermResearch, PLLC
  • Pedia Research, LLC
  • Medical Development Centers, LLC
  • Dermat. & Adv. Aesthetics
  • Clinical Trials of America, Inc.
  • Bay State Clinical Trials, Inc.
  • Great Lakes Research Group, Inc.
  • Somerset Skin Centre
  • Associated Skin Care Specs
  • MediSearch Clinical Trials
  • Central Dermatology
  • The Clinical Research Center, L.L.C.
  • J. Woodson Dermatology & Associates
  • Las Vegas Skin and Cancer Clinic
  • Dartmouth-Hitchcock Medical Center
  • Buffalo Medical Group, P.C.
  • Forest Hills Dermatology Group
  • New York University Medical
  • DermResearch Center of New York
  • PMG Research of Charlotte, LLC
  • Wake Research Associates, LLC
  • Wilmington Dermatology Center
  • PMG Research of Winston-Salem, LLC
  • Ohio State University Clinical Trials Management Office
  • Lynn Health Science Institute
  • Corvallis Clinic PC
  • Oregon Dermatology and Research Center
  • Oregon Medical Research Center, P.C.
  • University of Pittsburgh Medical Center Health System
  • Clinical Partners, LLC
  • Radiant Research, Inc.
  • Health Concepts
  • PMG Research of Bristol, LLC
  • Austin Dermatology Associates
  • Menter Dermatology Research Institute
  • Modern Research Associates
  • Stephen Miller MD
  • Center for Clinical Studies
  • Advanced Research Institute
  • Premier Clinical Research
  • Mountain State Clinical Research
  • UMHAT Dr. Georgi Stranski, EAD
  • Center for Skin and Venereal Diseases EOOD Sofia
  • UMHAT "Alexandrovska", EAD
  • Diagnostic-consulting center 3-Varna EOOD
  • Hopital de l'Archet 2
  • Hôpital Charles Nicolle
  • Kozne oddelenie,Nemocnica Kosice-Saca a.s.,1. sukromna nemoc
  • Pedi-Derma s.r.o., Dermatovenerologicka ambulancia
  • SANARE s.r.o.
  • SANARE s.r.o. Dermatovenerologická ambulancia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

GP2017 Adalimumab

Humira ® Adalimumab

Arm Description

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 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.

Outcomes

Primary Outcome Measures

PASI 75 Response Rate at Week 16 - GP2017 Adalimumab vs Humira ® Adalimumab
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

Mean Percent Change From Baseline in PASI Score up to Week 16 (MMRM)
The key secondary efficacy variable was the percentage change from baseline in PASI score at each visit up to Week 16.
Mean ATE of Percent Change From Baseline in PASI Score up to Week 16 (ANCOVA)
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).
PASI 50, PASI 75, PASI 90 and PASI 100 Response Rates
Proportion of patients achieving PASI 50, 75, 90 and 100 at Week 17 (end of Treatment Period 1)
PASI 50, PASI75, PASI 90 and PASI100 Response Rates
Proportion of Patients Achieving PASI 50, 75, 90 and 100 at Week 35 (end of Treatment Period 2)
PASI 50, PASI75, PASI 90 and PASI100 Response Rates
Proportion of Patients Achieving PASI 50, 75, 90 and 100 at Week 51 (Entire Study)
IGA Response Rate
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 17.
IGA Response Rate
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
IGA Response Rate
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
DLQI
Proportion of patients reporting a DLQI of 0 or 1 (no effect at all on patient's life)
DLQI
Proportion of patients reporting a DLQI of 0 or 1 (no effect at all on patient's life)
DLQI
Proportion of patients reporting a DLQI of 0 or 1 (no effect at all on patient's life)
ADA Formation Against GP2017 Adalimumab and Humira® Adalimumab From Randomization Until Week 17
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.
ADA Formation Against GP2017 Adalimumab and Humira® Adalimumab From Randomization Until Week 51
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.

Full Information

First Posted
December 14, 2013
Last Updated
April 24, 2017
Sponsor
Sandoz
Collaborators
Hexal AG
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1. Study Identification

Unique Protocol Identification Number
NCT02016105
Brief Title
Study to Demonstrate Equivalent Efficacy and to Compare Safety of Biosimilar Adalimumab (GP2017) and Humira
Acronym
ADACCESS
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 Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sandoz
Collaborators
Hexal AG

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Type Psoriasis
Keywords
plaque type psoriasis, equivalent efficacy, safety and immunogenicity, GP2017, Humira®

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
465 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GP2017 Adalimumab
Arm Type
Experimental
Arm Description
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.
Arm Title
Humira ® Adalimumab
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
GP2017 Adalimumab
Intervention Type
Drug
Intervention Name(s)
Humira ® Adalimumab
Primary Outcome Measure Information:
Title
PASI 75 Response Rate at Week 16 - GP2017 Adalimumab vs Humira ® Adalimumab
Description
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.
Time Frame
At Week 16 only
Secondary Outcome Measure Information:
Title
Mean Percent Change From Baseline in PASI Score up to Week 16 (MMRM)
Description
The key secondary efficacy variable was the percentage change from baseline in PASI score at each visit up to Week 16.
Time Frame
Baseline to Week 16
Title
Mean ATE of Percent Change From Baseline in PASI Score up to Week 16 (ANCOVA)
Description
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).
Time Frame
Baseline to Week 16
Title
PASI 50, PASI 75, PASI 90 and PASI 100 Response Rates
Description
Proportion of patients achieving PASI 50, 75, 90 and 100 at Week 17 (end of Treatment Period 1)
Time Frame
At Week 17 only
Title
PASI 50, PASI75, PASI 90 and PASI100 Response Rates
Description
Proportion of Patients Achieving PASI 50, 75, 90 and 100 at Week 35 (end of Treatment Period 2)
Time Frame
At Week 35 only
Title
PASI 50, PASI75, PASI 90 and PASI100 Response Rates
Description
Proportion of Patients Achieving PASI 50, 75, 90 and 100 at Week 51 (Entire Study)
Time Frame
At Week 51 only
Title
IGA Response Rate
Description
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 17.
Time Frame
At Week 17 only
Title
IGA Response Rate
Description
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
Time Frame
At Week 35 only
Title
IGA Response Rate
Description
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
Time Frame
At Week 51 only
Title
DLQI
Description
Proportion of patients reporting a DLQI of 0 or 1 (no effect at all on patient's life)
Time Frame
At Week 17 only
Title
DLQI
Description
Proportion of patients reporting a DLQI of 0 or 1 (no effect at all on patient's life)
Time Frame
At Week 35 only
Title
DLQI
Description
Proportion of patients reporting a DLQI of 0 or 1 (no effect at all on patient's life)
Time Frame
At Week 51 only
Title
ADA Formation Against GP2017 Adalimumab and Humira® Adalimumab From Randomization Until Week 17
Description
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.
Time Frame
At Week 17 only
Title
ADA Formation Against GP2017 Adalimumab and Humira® Adalimumab From Randomization Until Week 51
Description
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.
Time Frame
At Week 51 only

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Total Skin & Beauty Dermatology Center
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Alliance Dermatology & MOHS Center, PC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Burke Pharmaceutical Research
City
Hot Springs
State/Province
Arkansas
Country
United States
Facility Name
Anaheim Clinical Trials
City
Anaheim
State/Province
California
Country
United States
Facility Name
Bakersfield Dermatology and Skin Cancer Medical Group
City
Bakersfield
State/Province
California
Country
United States
Facility Name
Wallace Medical Group
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
California Dermatology & Clinical Research Institute
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Dr. Howard Sofen
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Southern California Permanente Medical Group
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Palmtree Clinical Research
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
Medical Center For Clinical Research
City
San Diego
State/Province
California
Country
United States
Facility Name
Therapeutics Clinical Research
City
San Diego
State/Province
California
Country
United States
Facility Name
Clinical Science Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Ventura Clinical Trials
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Facility Name
Horizons Clinical Research Center, LLC
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Savin Dermatology Center, P.C.
City
New Haven
State/Province
Connecticut
Country
United States
Facility Name
Florida Academic Dermatology Center
City
Coral Gables
State/Province
Florida
Country
United States
Facility Name
Florida Medical Center & Research Inc
City
Miami
State/Province
Florida
Country
United States
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Psoriasis Treatment Center of South Florida
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Facility Name
McIlwain Medical Group, PA
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
MedPhase, Inc.
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30263
Country
United States
Facility Name
Pharmaceutical Research Organization
City
Rigby
State/Province
Idaho
Country
United States
Facility Name
Dundee Derm.
City
West Dundee
State/Province
Illinois
Country
United States
Facility Name
Dawes Fretzin Clinical Research Group, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
The Dermatology Center, PSC
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
The Indiana Clinical Trials Center
City
Plainfield
State/Province
Indiana
Country
United States
Facility Name
Dermatology Specialists Research, LLC
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
DermResearch, PLLC
City
Louisville
State/Province
Kentucky
Country
United States
Facility Name
Pedia Research, LLC
City
Owensboro
State/Province
Kentucky
Country
United States
Facility Name
Medical Development Centers, LLC
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
Dermat. & Adv. Aesthetics
City
Lake Charles
State/Province
Louisiana
Country
United States
Facility Name
Clinical Trials of America, Inc.
City
Monroe
State/Province
Louisiana
Country
United States
Facility Name
Bay State Clinical Trials, Inc.
City
Watertown
State/Province
Massachusetts
Country
United States
Facility Name
Great Lakes Research Group, Inc.
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48706
Country
United States
Facility Name
Somerset Skin Centre
City
Troy
State/Province
Michigan
Country
United States
Facility Name
Associated Skin Care Specs
City
Fridley
State/Province
Minnesota
Country
United States
Facility Name
MediSearch Clinical Trials
City
Saint Joseph
State/Province
Missouri
Country
United States
Facility Name
Central Dermatology
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
The Clinical Research Center, L.L.C.
City
Saint Louis
State/Province
Missouri
Country
United States
Facility Name
J. Woodson Dermatology & Associates
City
Henderson
State/Province
Nevada
Country
United States
Facility Name
Las Vegas Skin and Cancer Clinic
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Buffalo Medical Group, P.C.
City
Buffalo
State/Province
New York
Country
United States
Facility Name
Forest Hills Dermatology Group
City
Forest Hills
State/Province
New York
ZIP/Postal Code
11375
Country
United States
Facility Name
New York University Medical
City
Lake Success
State/Province
New York
ZIP/Postal Code
11041
Country
United States
Facility Name
DermResearch Center of New York
City
Stony Brook
State/Province
New York
Country
United States
Facility Name
PMG Research of Charlotte, LLC
City
Charlotte
State/Province
North Carolina
Country
United States
Facility Name
Wake Research Associates, LLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Wilmington Dermatology Center
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28403
Country
United States
Facility Name
PMG Research of Winston-Salem, LLC
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
Ohio State University Clinical Trials Management Office
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
Lynn Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Corvallis Clinic PC
City
Corvallis
State/Province
Oregon
ZIP/Postal Code
97330
Country
United States
Facility Name
Oregon Dermatology and Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Oregon Medical Research Center, P.C.
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
University of Pittsburgh Medical Center Health System
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Clinical Partners, LLC
City
Johnston
State/Province
Rhode Island
Country
United States
Facility Name
Radiant Research, Inc.
City
Greer
State/Province
South Carolina
Country
United States
Facility Name
Health Concepts
City
Rapid City
State/Province
South Dakota
Country
United States
Facility Name
PMG Research of Bristol, LLC
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
Austin Dermatology Associates
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Menter Dermatology Research Institute
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Modern Research Associates
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Stephen Miller MD
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78249
Country
United States
Facility Name
Center for Clinical Studies
City
Webster
State/Province
Texas
Country
United States
Facility Name
Advanced Research Institute
City
Ogden
State/Province
Utah
Country
United States
Facility Name
Premier Clinical Research
City
Spokane
State/Province
Washington
Country
United States
Facility Name
Mountain State Clinical Research
City
Clarksburg
State/Province
West Virginia
Country
United States
Facility Name
UMHAT Dr. Georgi Stranski, EAD
City
Pleven
Country
Bulgaria
Facility Name
Center for Skin and Venereal Diseases EOOD Sofia
City
Sofia
Country
Bulgaria
Facility Name
UMHAT "Alexandrovska", EAD
City
Sofia
Country
Bulgaria
Facility Name
Diagnostic-consulting center 3-Varna EOOD
City
Varna
Country
Bulgaria
Facility Name
Hopital de l'Archet 2
City
Nice Cedex 3
Country
France
Facility Name
Hôpital Charles Nicolle
City
Rouen
Country
France
Facility Name
Kozne oddelenie,Nemocnica Kosice-Saca a.s.,1. sukromna nemoc
City
Kosice-Saca
Country
Slovakia
Facility Name
Pedi-Derma s.r.o., Dermatovenerologicka ambulancia
City
Kosice
Country
Slovakia
Facility Name
SANARE s.r.o.
City
Svidnik
Country
Slovakia
Facility Name
SANARE s.r.o. Dermatovenerologická ambulancia
City
Svidník
ZIP/Postal Code
08901
Country
Slovakia

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33651341
Citation
Blauvelt A, Leonardi CL, Gaylis N, Jauch-Lembach J, Balfour A, Lemke L, Hachaichi S, Brueckmann I, Festini T, Wiland P. Treatment with SDZ-ADL, an Adalimumab Biosimilar, in Patients with Rheumatoid Arthritis, Psoriasis, or Psoriatic Arthritis: Results of Patient-Reported Outcome Measures from Two Phase III Studies (ADMYRA and ADACCESS). BioDrugs. 2021 Mar;35(2):229-238. doi: 10.1007/s40259-021-00470-1. Epub 2021 Mar 2.
Results Reference
derived

Learn more about this trial

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

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