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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02016105
Recruitment Status : Completed
First Posted : December 19, 2013
Results First Posted : April 7, 2017
Last Update Posted : May 30, 2017
Sponsor:
Collaborator:
Hexal AG
Information provided by (Responsible Party):
Sandoz

Tracking Information
First Submitted Date  ICMJE December 14, 2013
First Posted Date  ICMJE December 19, 2013
Results First Submitted Date  ICMJE February 22, 2017
Results First Posted Date  ICMJE April 7, 2017
Last Update Posted Date May 30, 2017
Study Start Date  ICMJE December 2013
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2017)
PASI 75 Response Rate at Week 16 - GP2017 Adalimumab vs Humira ® Adalimumab [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 14, 2013)
The primary outcome measure is the PASI 75 response rate [ Time Frame: Week 17 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2017)
  • Mean Percent Change From Baseline in PASI Score up to Week 16 (MMRM) [ Time Frame: 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.
  • Mean ATE of Percent Change From Baseline in PASI Score up to Week 16 (ANCOVA) [ Time Frame: 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).
  • PASI 50, PASI 75, PASI 90 and PASI 100 Response Rates [ Time Frame: At Week 17 only ]
    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 [ Time Frame: At Week 35 only ]
    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 [ Time Frame: At Week 51 only ]
    Proportion of Patients Achieving PASI 50, 75, 90 and 100 at Week 51 (Entire Study)
  • IGA Response Rate [ Time Frame: At Week 17 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 17.
  • IGA Response Rate [ Time Frame: At Week 35 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
  • IGA Response Rate [ Time Frame: 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
  • DLQI [ Time Frame: At Week 17 only ]
    Proportion of patients reporting a DLQI of 0 or 1 (no effect at all on patient's life)
  • DLQI [ Time Frame: At Week 35 only ]
    Proportion of patients reporting a DLQI of 0 or 1 (no effect at all on patient's life)
  • DLQI [ Time Frame: At Week 51 only ]
    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 [ Time Frame: 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.
  • ADA Formation Against GP2017 Adalimumab and Humira® Adalimumab From Randomization Until Week 51 [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 14, 2013)
  • PASI 50, 75, 90 and 100 response rates [ Time Frame: Weeks 1,3,5,7,9,11,13, 15,16,17 ]
  • Change from baseline in IGA [ Time Frame: Weeks 1, 3, 5, 7, 9, 11, 13, 15, 16 and 17 ]
  • Patient't health related quality of life (HRQoL) [ Time Frame: Week 11 and 16 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Demonstrate Equivalent Efficacy and to Compare Safety of Biosimilar Adalimumab (GP2017) and Humira
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Plaque Type Psoriasis
Intervention  ICMJE
  • Drug: GP2017 Adalimumab
  • Drug: Humira ® Adalimumab
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Drug: GP2017 Adalimumab
  • Active Comparator: 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.
    Intervention: Drug: Humira ® Adalimumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 1, 2016)
465
Original Estimated Enrollment  ICMJE
 (submitted: December 14, 2013)
448
Actual Study Completion Date  ICMJE February 2016
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   France,   Slovakia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02016105
Other Study ID Numbers  ICMJE GP17-301
2013-000747-11 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Sandoz
Study Sponsor  ICMJE Sandoz
Collaborators  ICMJE Hexal AG
Investigators  ICMJE Not Provided
PRS Account Sandoz
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP