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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02016105
First Posted: December 19, 2013
Last Update Posted: May 30, 2017
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.
Collaborator:
Hexal AG
Information provided by (Responsible Party):
Sandoz
  Purpose
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.

Condition Intervention Phase
Plaque Type Psoriasis Drug: GP2017 Adalimumab Drug: Humira ® Adalimumab Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Sandoz:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.



Enrollment: 465
Study Start Date: December 2013
Study Completion Date: February 2016
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
Drug: Humira ® Adalimumab

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02016105


  Show 79 Study Locations
Sponsors and Collaborators
Sandoz
Hexal AG
  More Information

Responsible Party: Sandoz
ClinicalTrials.gov Identifier: NCT02016105     History of Changes
Other Study ID Numbers: GP17-301
2013-000747-11 ( EudraCT Number )
First Submitted: December 14, 2013
First Posted: December 19, 2013
Results First Submitted: February 22, 2017
Results First Posted: April 7, 2017
Last Update Posted: May 30, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Sandoz:
plaque type psoriasis
equivalent efficacy
safety and immunogenicity
GP2017
Humira®

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents